Castration-Resistant Prostate CarcinomaPhase 2NCT06039371
Supraphysiological Androgen to Enhance Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study
A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Bone Scan in people with Castration-Resistant Prostate Carcinoma and Metastatic Prostate Adenocarcinoma, run by University of Washington at 1 site in United States.
Trial summary
This phase II trial studies how well giving testosterone at levels higher than normally found in the body (supraphysiological) works to enhance chemotherapy treatment, and Lutetium 177Lu-prostate specific-membrane antigen (PSMA)-617 (LuPSMA) in patients with prostate cancer that has progressed despite being previously… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
- What is being tested?
- Biopsy Procedure, Biospecimen Collection and Bone Scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2024to 1 Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be willing to provide informed consent prior to any study specific procedures
- Age >= 18 years
- Documented histologically confirmed adenocarcinoma of the prostate
- Patient must have evidence of castration resistant prostate cancer as evidenced by PSA progression (per Prostate Cancer Working Group 3 [PCWG3] criteria) and a castrate serum testosterone level (i.e., =< 50 mg/dL)
- PSA must be at least 2 ng/ml and rising on two successive measurements at least two weeks apart
- Patients must have progressed on at least one prior next-generation androgen receptor-signalling inhibitor (e.g., abiraterone, enzalutamide, etc.). There must be at least a 2-week washout period after stopping the most recent approved therapy for metastatic castration-resistant prostate cancer (mCRPC) (e.g., abiraterone, enzalutamide, Ra-223, sipuleucel-t) prior to cycle 1, day 1. If applicable, patients should be weaned off steroids at least 1 week prior to starting treatment
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- Subjects enrolling to Cohort 3 must demonstrate evidence of PSMA expression on 68Ga-PSMA-11 PET as defined in the VISION trial
- No prior chemotherapy for the treatment of mCRPC. Patients may have received docetaxel for the treatment of hormone-sensitive prostate cancer
- Prior treatment with non-chemotherapy investigational agents is permitted. There must be at least a 2-week washout period after stopping any investigational cancer agent prior to cycle 1, day 1
- Hemoglobin >= 9 g/dL with no blood transfusion in the past 28 days (within 30 days prior to administration of study treatment)
- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (within 30 days prior to administration of study treatment)
- Platelet count >= 100 x 10^9/L (within 30 days prior to administration of study treatment)
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 30 days prior to administration of study treatment)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be =< 5x ULN (within 30 days prior to administration of study treatment)
- Patients must have creatinine clearance estimated using the Cockcroft-Gault equation or based on 24 hour urine test of >= 51 mL/min (within 30 days prior to administration of study treatment)
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Patients must have a life expectancy >= 16 weeks
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
- At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by CT, positron emission tomography (PET), magnetic resonance imaging (MRI) and/or bone scan and is suitable for repeated assessment
- Must be willing to undergo metastatic biopsy and have a lesion amenable for biopsy
- Male patients and their partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination, throughout the period of taking study treatment and for 6 months after last dose of study drug(s) to prevent pregnancy in a partner
Who cannot join
- Involvement in the planning and/or conduct of the study
- Other malignancy unless curatively treated with no evidence of disease for >= 2 years except: adequately treated non-melanoma skin cancer, non-muscle invasive bladder cancer
- Persistent toxicities (Common Terminology Criteria for Adverse Event (CTCAE) grade > 2) caused by previous cancer therapy, excluding alopecia
- Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
- Use of corticosteroids at a dose equivalent to > 10 mg of prednisone daily
- Planning to receive concurrent treatment with another systemic cancer therapy, aside from a luteinizing hormone releasing hormone (LHRH) analogue
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- Use of warfarin is not permitted. Low-molecular weight heparin and direct oral anticoagulants are allowed, but their use should be discussed with the principal investigator (PI) first
- Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, uncontrolled major seizure disorder, uncontrolled hypertension (blood pressure [BP] >= 165/100), history of prior stroke, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease or any psychiatric disorder that prohibits obtaining informed consent
- Patients with a known hypersensitivity to the testosterone cypionate, etoposide, carboplatin or any of the excipients of these products
- Patients with known active hepatitis (i.e., hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids
- Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
- Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
- Evidence of disease that, in the opinion of the investigator, would put the patient at risk from testosterone therapy (e.g. femoral metastases with concern over fracture risk, spinal metastases with concern over spinal cord compression, lymph node disease with concern for ureteral obstruction)
- Patients with pain attributable to their prostate cancer.
- Excluded due to concern for pain flare due to testosterone supplementation
- Tumor causing urinary outlet obstruction that requires catheterization for voiding. Patients that require catheterization to void secondary to benign strictures or other non-cancer causes will be permitted to enroll. Patients with percutaneous nephrostomy tubes will also be permitted to enroll
- Prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to enrollment in the study and not currently on systemic anticoagulation.
- Excluded due to risk of venous thromboembolism from hormone supplementation
- Patients with NYHA (New York Heart Association) class III or IV heart failure or history of a prior myocardial infarction (MI) within 5 years of enrollment to the study.
- Excluded due to increased risk of cardiovascular events with testosterone supplementation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Michael Schweizer, 206-606-6252, schweize@uw.edu
Michael Schweizer
About this study
Official title: SPECTRA: Supraphysiological Androgen to Enhance Treatment Activity
This phase II trial studies how well giving testosterone at levels higher than normally found in the body (supraphysiological) works to enhance chemotherapy treatment, and Lutetium 177Lu-prostate specific-membrane antigen (PSMA)-617 (LuPSMA) in patients with prostate cancer that has progressed despite being previously treated with androgen therapies and has spread from where it first started (prostate) to other places in the body (metastatic castration-resistant prostate cancer). In patients that have developed progressive cancer in spite of standard hormonal treatment, administering supraphysiological testosterone may result in regression of tumors by causing deoxyribonucleic acid (DNA) damage in tumor cells that have adapted to low testosterone conditions. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Radioactive drugs, such as LuPSMA, may carry radiation directly to tumor cells and not harm normal cells. Giving supraphysiological levels of testosterone and carboplatin or etoposide or LuPSMA together may be an effective treatment for metastatic castration-resistant prostate cancer.
Read the detailed description
OUTLINE:
Patients are assigned based on personal preference to 1 of 3 cohorts.
COHORT I: Patients are then assigned to 1 of 3 sub-cohorts within cohort I.
COHORT Ia: Patients continue to receive ADT and receive testosterone cypionate intramuscularly (IM) on day 1 of cycle 1. Patients then receive testosterone cypionate IM and carboplatin intravenously (IV) on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
COHORT Ib: Patients continue to receive ADT and receive carboplatin IV on day 1 of cycle 1. Patients then receive testosterone cypionate IM and carboplatin IV on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
COHORT Ic: Patients continue to receive ADT and receive testosterone cypionate IM and carboplatin IV on day 1 of cycle 1. Patients then receive testosterone cypionate IM and carboplatin IV on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
COHORT II: Patients are then assigned to 1 of 3 sub-cohorts within cohort II.
COHORT IIa: Patients continue to receive ADT and receive testosterone cypionate IM on day 1 of cycle 1. Patients then receive testosterone cypionate IM on day 1 and etoposide orally (PO) once daily (QD) on days 1-14 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
COHORT IIb: Patients continue to receive ADT and receive etoposide PO QD on days 1-14 of cycle 1. Patients then receive testosterone cypionate IM on day 1 and etoposide PO QD on days 1-14 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
COHORT IIc: Patients continue to receive ADT and receive testosterone cypionate IM on day 1 and etoposide PO QD on days 1-14 of cycle 1. Patients then receive testosterone cypionate IM on day 1 and etoposide PO QD on days 1-14 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
COHORT III: Patients are assigned to 1 of 3 sub-cohorts within cohort III.
COHORT IIIa: Patients continue to receive ADT and receive testosterone cypionate intramuscularly (IM) on day 1 of cycles 1-6. Patients receive LuPSMA IV on day 1 of cycles 2-6. Cycles repeat every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive testosterone cypionate intramuscularly (IM) on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo 68Ga-PSMA positron emission tomography (PET) at screening and single photon emission computed tomography (SPECT)/CT throughout the study.
COHORT IIIb: Patients continue to receive ADT and LuPSMA IV on day 1 of cycles 1-6. Patients also receive receive testosterone cypionate IM on day 1 of cycles 2-6 . Cycles repeat every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive testosterone cypionate IM on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo 68Ga-PSMA PET at screening and single SPECT/CT throughout the study.
COHORT IIIc: Patients continue to receive ADT and receive testosterone cypionate IM on day 1 and LuPSMA IV on day 1 of cycles 1-6. Cycles repeat every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive testosterone cypionate IM on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo 68Ga-PSMA PET at screening and single SPECT/CT throughout the study.
All patients undergo a biopsy on study and blood sample collection on study, and bone scans, dual x-ray absorptiometry (DEXA) and computed tomography (CT) scans throughout the trial. Patients may also undergo an optional second biopsy at the end of study treatment.
After completion of study treatment, patients are followed up at 30 days, and then every 6 months for 2 years.
- Conditions
- Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
- Being tested
- Biopsy Procedure, Biospecimen Collection, Bone Scan, Carboplatin, Computed Tomography
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy ProcedureProcedure or surgery
Also called Biopsy, BIOPSY_TYPE, Bx
Undergo a biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Bone ScanProcedure or surgery
Also called Bone Scintigraphy
Undergo bone scan
CarboplatinDrug
Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino
Given IV
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
EtoposideDrug
Also called Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar
Given PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Testosterone CypionateDrug
Also called depAndro, Depo-Testosterone, Depotest, Depovirin
Given IM
RadioconjugateOther
Also called Radio Conjugates
Given LuPSMA IV
Dual X-ray AbsorptiometryProcedure or surgery
Also called BMD scan, bone mineral density scan, DEXA, DEXA scan
Undergo DEXA
Gallium Ga 68-PSMA-617Other
Also called 2247839-19-4, 68Ga-PSMA-617, Gallium-68 PSMA-617, VIPIVOTIDE TETRAXETAN GALLIUM GA-68
Given gallium 68Ga-PSMA-617
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, PET, PET scan
Undergo 68Ga-PSMA PET
Single Photon Emission Computed TomographyProcedure or surgery
Also called Medical Imaging, SPECT
Undergo SPECT/CT
| Study group | Role | What they receive |
|---|---|---|
| Cohort Ia (testosterone cypionate, carboplatin) | Active comparator | Patients continue to receive ADT per standard of care and receive testosterone cypionate IM on day 1 of cycle 1. Patients then receive testosterone cypionate IM and carboplatin IV on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy, blood sample collection, bone scan and CT scan throughout the study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Drug: Carboplatin; Procedure: Computed Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Testosterone Cypionate; Procedure: Dual X-ray Absorptiometry |
| Cohort Ib (testosterone cypionate, carboplatin) | Active comparator | Patients continue to receive ADT per standard of care and receive carboplatin IV on day 1 of cycle 1. Patients then receive testosterone cypionate IM and carboplatin IV on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy, blood sample collection, bone scan and CT scan throughout the study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Drug: Carboplatin; Procedure: Computed Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Testosterone Cypionate; Procedure: Dual X-ray Absorptiometry |
| Cohort Ic (testosterone cypionate, carboplatin) | Experimental | Patients continue to receive ADT per standard of care and receive testosterone cypionate IM and carboplatin IV on day 1 of cycle 1. Patients then receive testosterone cypionate IM and carboplatin IV on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy, blood sample collection, bone scan and CT scan throughout the study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Drug: Carboplatin; Procedure: Computed Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Testosterone Cypionate; Procedure: Dual X-ray Absorptiometry |
| Cohort IIa (testosterone cypionate, etoposide) | Active comparator | Patients continue to receive ADT per standard of care and receive testosterone cypionate IM on day 1 of cycle 1. Patients then receive testosterone cypionate IM on day 1 and etoposide PO QD on days 1-14 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy, blood sample collection, bone scan and CT scan throughout the study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Drug: Etoposide; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Testosterone Cypionate; Procedure: Dual X-ray Absorptiometry |
| Cohort IIb (testosterone cypionate, etoposide) | Active comparator | Patients continue to receive ADT per standard of care and receive etoposide PO QD on days 1-14 of cycle 1. Patients then receive testosterone cypionate IM on day 1 and etoposide PO QD on days 1-14 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy, blood sample collection, bone scan and CT scan throughout the study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Drug: Etoposide; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Testosterone Cypionate; Procedure: Dual X-ray Absorptiometry |
| Cohort IIc (testosterone cypionate, etoposide) | Experimental | Patients continue to receive ADT per standard of care and receive testosterone cypionate IM on day 1 and etoposide PO QD on days 1-14 of cycle 1. Patients then receive testosterone cypionate IM on day 1 and etoposide PO QD on days 1-14 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy, blood sample collection, bone scan and CT scan throughout the study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Drug: Etoposide; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Testosterone Cypionate; Procedure: Dual X-ray Absorptiometry |
| Cohort IIIa (ADT, testosterone cypionate, LuPSMA) | Experimental | Patients continue to receive ADT per standard of care and receive testosterone cypionate IM on day 1 of cycles 1-6. Patients receive LuPSMA IV on day 1 of cycles 2-6. Cycles repeat every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive testosterone cypionate IM on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy on study and blood sample collection on study, and bone scans, DEXA and CT scans throughout the trial. Patients may also undergo an optional second biopsy at the end of study treatment. Patients also undergo 68Ga-PSMA PET at screening and SPECT/CT throughout the study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Testosterone Cypionate; Other: Radioconjugate; Procedure: Dual X-ray Absorptiometry; Other: Gallium Ga 68-PSMA-617; Procedure: Positron Emission Tomography; Procedure: Single Photon Emission Computed Tomography |
| Cohort IIIb (ADT, testosterone cypionate, LuPSMA) | Experimental | Patients continue to receive ADT per standard of care and LuPSMA IV on day 1 of cycles 1-6. Patients also receive testosterone cypionate IM on day 1 of cycles 2-6 . Cycles repeat every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive testosterone cypionate IM on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo 68Ga-PSMA PET at screening and SPECT/CT throughout the study. All patients undergo a biopsy on study and blood sample collection on study, and bone scans, DEXA and CT scans throughout the trial. Patients may also undergo an optional second biopsy at the end of study treatment. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Testosterone Cypionate; Other: Radioconjugate; Procedure: Dual X-ray Absorptiometry; Other: Gallium Ga 68-PSMA-617; Procedure: Positron Emission Tomography; Procedure: Single Photon Emission Computed Tomography |
| Cohort IIIc (ADT, testosterone cypionate, LuPSMA) | Experimental | Patients continue to receive ADT per standard of care and receive testosterone cypionate IM on day 1 and LuPSMA IV on day 1 of cycles 1-6. Cycles repeat every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive testosterone cypionate IM on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo 68Ga-PSMA PET at screening and SPECT/CT throughout the study. All patients undergo a biopsy on study and blood sample collection on study, and bone scans, DEXA and CT scans throughout the trial. Patients may also undergo an optional second biopsy at the end of study treatment. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Testosterone Cypionate; Other: Radioconjugate; Procedure: Dual X-ray Absorptiometry; Other: Gallium Ga 68-PSMA-617; Procedure: Positron Emission Tomography; Procedure: Single Photon Emission Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Greater than or equal to 50% decline in prostate-specific antigen from baseline (PSA50) response rate
Will assess >= 50% decline in PSA following treatment with combination bipolar androgen therapy (BAT) and genotoxic chemotherapy (at least 12 weeks of total therapy). Will be calculated as the percentage with 95% confidence interval (CI) of the total number of subjects that achieved a PSA50 response.
Measured: From baseline up to 3 years
Secondary outcomes (6)
Radiographic response
Will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Best radiographic response for each patient will be presented in a waterfall plot.
Measured: Up to 3 years
Radiographic progression-free survival (PFS)
Will be assessed using RECIST 1.1 and Prostate Cancer Working Group 3 (PCWG3) criteria. Will be presented with Kaplan-Meier curves, and the median survival with 95% CI will be calculated. Rates will be reported as percentages with 95% CI.
Measured: The start of treatment until disease progression (per modified RECIST criteria or PCWG3 criteria for bone lesions), clinical progression (as determined by the treating physician), or death, whichever occurs first, assessed up to 3 years
PSA PFS
Will be assessed using PCWG3 criteria. Will be presented with Kaplan-Meier curves, and the median survival with 95% CI will be calculated. Rates will be reported as percentages with 95% CI. Best on study PSA for each patient will be presented in a waterfall plot.
Measured: Time from the start of treatment until PSA progression (as defined by PCWG3 criteria), assessed up to 3 years
Overall survival
Will be presented with Kaplan-Meier curves, and the median survival with 95% CI will be calculated. Rates will be reported as percentages with 95% CI.
Measured: The start of treatment until death from any cause, assessed up to 3 years
Patient-reported outcome measure (PROMS) questionnaires
Will be assessed by average change in quality of life (QOL) scores (total and for each domain) for each survey will be calculated at each timepoint. A paired t-test will used to assess for statistically significant changes in QOL from baseline to subsequent timepoints, and linear mixed effects models will be used to evaluate trends over all timepoints.
Measured: Up to 3 years
Incidence of adverse events
Will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 30 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start21 May 2024
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration-Resistant Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael Schweizer, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039371
- Sponsor's protocol ID
- RG1123642
- Other IDs
- NCI-2023-05597, FHIRB0020106, 2P50CA097186
- Status last verified
- Jul 2026
- First submitted
- 21 Aug 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPECTRA: Supraphysiological Androgen to Enhance Treatment Activity
- ClinicalTrials.gov ID
- NCT06039371
- Acronym / sponsor ID
- RG1123642
- Conditions
- Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 May 2024 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well giving testosterone at levels higher than normally found in the body (supraphysiological) works to enhance chemotherapy treatment, and Lutetium 177Lu-prostate specific-membrane antigen (PSMA)-617 (LuPSMA) in patients with prostate cancer that has progressed despite being previously treated with androgen therapies and has spread from where it first started (prostate) to other places in the body (metastatic castration-resistant prostate cancer). In patients that have developed progressive cancer in spite of standard hormonal treatment, administering supraphysiological testosterone may result in regression of tumors by causing deoxyribonucleic acid (DNA) damage in tumor cells that have adapted to low testosterone conditions. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Radioactive drugs, such as LuPSMA, may carry radiation directly to tumor cells and not harm normal cells. Giving supraphysiological levels of testosterone and carboplatin or etoposide or LuPSMA together may be an effective treatment for metastatic castration-resistant prostate cancer.
Detailed description
OUTLINE:
Patients are assigned based on personal preference to 1 of 3 cohorts.
COHORT I: Patients are then assigned to 1 of 3 sub-cohorts within cohort I.
COHORT Ia: Patients continue to receive ADT and receive testosterone cypionate intramuscularly (IM) on day 1 of cycle 1. Patients then receive testosterone cypionate IM and carboplatin intravenously (IV) on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
COHORT Ib: Patients continue to receive ADT and receive carboplatin IV on day 1 of cycle 1. Patients then receive testosterone cypionate IM and carboplatin IV on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
COHORT Ic: Patients continue to receive ADT and receive testosterone cypionate IM and carboplatin IV on day 1 of cycle 1. Patients then receive testosterone cypionate IM and carboplatin IV on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
COHORT II: Patients are then assigned to 1 of 3 sub-cohorts within cohort II.
COHORT IIa: Patients continue to receive ADT and receive testosterone cypionate IM on day 1 of cycle 1. Patients then receive testosterone cypionate IM on day 1 and etoposide orally (PO) once daily (QD) on days 1-14 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
COHORT IIb: Patients continue to receive ADT and receive etoposide PO QD on days 1-14 of cycle 1. Patients then receive testosterone cypionate IM on day 1 and etoposide PO QD on days 1-14 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
COHORT IIc: Patients continue to receive ADT and receive testosterone cypionate IM on day 1 and etoposide PO QD on days 1-14 of cycle 1. Patients then receive testosterone cypionate IM on day 1 and etoposide PO QD on days 1-14 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
COHORT III: Patients are assigned to 1 of 3 sub-cohorts within cohort III.
COHORT IIIa: Patients continue to receive ADT and receive testosterone cypionate intramuscularly (IM) on day 1 of cycles 1-6. Patients receive LuPSMA IV on day 1 of cycles 2-6. Cycles repeat every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive testosterone cypionate intramuscularly (IM) on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo 68Ga-PSMA positron emission tomography (PET) at screening and single photon emission computed tomography (SPECT)/CT throughout the study.
COHORT IIIb: Patients continue to receive ADT and LuPSMA IV on day 1 of cycles 1-6. Patients also receive receive testosterone cypionate IM on day 1 of cycles 2-6 . Cycles repeat every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive testosterone cypionate IM on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo 68Ga-PSMA PET at screening and single SPECT/CT throughout the study.
COHORT IIIc: Patients continue to receive ADT and receive testosterone cypionate IM on day 1 and LuPSMA IV on day 1 of cycles 1-6. Cycles repeat every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive testosterone cypionate IM on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo 68Ga-PSMA PET at screening and single SPECT/CT throughout the study.
All patients undergo a biopsy on study and blood sample collection on study, and bone scans, dual x-ray absorptiometry (DEXA) and computed tomography (CT) scans throughout the trial. Patients may also undergo an optional second biopsy at the end of study treatment.
After completion of study treatment, patients are followed up at 30 days, and then every 6 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort Ia (testosterone cypionate, carboplatin) | Active comparator | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Drug: Carboplatin, Procedure: Computed Tomography, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Testosterone Cypionate, Procedure: Dual X-ray AbsorptiometryPatients continue to receive ADT per standard of care and receive testosterone cypionate IM on day 1 of cycle 1. Patients then receive testosterone cypionate IM and carboplatin IV on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy, blood sample collection, bone scan and CT scan throughout the study. |
| Cohort Ib (testosterone cypionate, carboplatin) | Active comparator | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Drug: Carboplatin, Procedure: Computed Tomography, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Testosterone Cypionate, Procedure: Dual X-ray AbsorptiometryPatients continue to receive ADT per standard of care and receive carboplatin IV on day 1 of cycle 1. Patients then receive testosterone cypionate IM and carboplatin IV on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy, blood sample collection, bone scan and CT scan throughout the study. |
| Cohort Ic (testosterone cypionate, carboplatin) | Experimental | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Drug: Carboplatin, Procedure: Computed Tomography, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Testosterone Cypionate, Procedure: Dual X-ray AbsorptiometryPatients continue to receive ADT per standard of care and receive testosterone cypionate IM and carboplatin IV on day 1 of cycle 1. Patients then receive testosterone cypionate IM and carboplatin IV on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy, blood sample collection, bone scan and CT scan throughout the study. |
| Cohort IIa (testosterone cypionate, etoposide) | Active comparator | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Procedure: Computed Tomography, Drug: Etoposide, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Testosterone Cypionate, Procedure: Dual X-ray AbsorptiometryPatients continue to receive ADT per standard of care and receive testosterone cypionate IM on day 1 of cycle 1. Patients then receive testosterone cypionate IM on day 1 and etoposide PO QD on days 1-14 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy, blood sample collection, bone scan and CT scan throughout the study. |
| Cohort IIb (testosterone cypionate, etoposide) | Active comparator | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Procedure: Computed Tomography, Drug: Etoposide, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Testosterone Cypionate, Procedure: Dual X-ray AbsorptiometryPatients continue to receive ADT per standard of care and receive etoposide PO QD on days 1-14 of cycle 1. Patients then receive testosterone cypionate IM on day 1 and etoposide PO QD on days 1-14 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy, blood sample collection, bone scan and CT scan throughout the study. |
| Cohort IIc (testosterone cypionate, etoposide) | Experimental | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Procedure: Computed Tomography, Drug: Etoposide, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Testosterone Cypionate, Procedure: Dual X-ray AbsorptiometryPatients continue to receive ADT per standard of care and receive testosterone cypionate IM on day 1 and etoposide PO QD on days 1-14 of cycle 1. Patients then receive testosterone cypionate IM on day 1 and etoposide PO QD on days 1-14 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy, blood sample collection, bone scan and CT scan throughout the study. |
| Cohort IIIa (ADT, testosterone cypionate, LuPSMA) | Experimental | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Procedure: Computed Tomography, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Testosterone Cypionate, Other: Radioconjugate, Procedure: Dual X-ray Absorptiometry, Other: Gallium Ga 68-PSMA-617, Procedure: Positron Emission Tomography, Procedure: Single Photon Emission Computed TomographyPatients continue to receive ADT per standard of care and receive testosterone cypionate IM on day 1 of cycles 1-6. Patients receive LuPSMA IV on day 1 of cycles 2-6. Cycles repeat every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive testosterone cypionate IM on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy on study and blood sample collection on study, and bone scans, DEXA and CT scans throughout the trial. Patients may also undergo an optional second biopsy at the end of study treatment. Patients also undergo 68Ga-PSMA PET at screening and SPECT/CT throughout the study. |
| Cohort IIIb (ADT, testosterone cypionate, LuPSMA) | Experimental | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Procedure: Computed Tomography, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Testosterone Cypionate, Other: Radioconjugate, Procedure: Dual X-ray Absorptiometry, Other: Gallium Ga 68-PSMA-617, Procedure: Positron Emission Tomography, Procedure: Single Photon Emission Computed TomographyPatients continue to receive ADT per standard of care and LuPSMA IV on day 1 of cycles 1-6. Patients also receive testosterone cypionate IM on day 1 of cycles 2-6 . Cycles repeat every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive testosterone cypionate IM on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo 68Ga-PSMA PET at screening and SPECT/CT throughout the study. All patients undergo a biopsy on study and blood sample collection on study, and bone scans, DEXA and CT scans throughout the trial. Patients may also undergo an optional second biopsy at the end of study treatment. |
| Cohort IIIc (ADT, testosterone cypionate, LuPSMA) | Experimental | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Procedure: Computed Tomography, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Testosterone Cypionate, Other: Radioconjugate, Procedure: Dual X-ray Absorptiometry, Other: Gallium Ga 68-PSMA-617, Procedure: Positron Emission Tomography, Procedure: Single Photon Emission Computed TomographyPatients continue to receive ADT per standard of care and receive testosterone cypionate IM on day 1 and LuPSMA IV on day 1 of cycles 1-6. Cycles repeat every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive testosterone cypionate IM on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo 68Ga-PSMA PET at screening and SPECT/CT throughout the study. All patients undergo a biopsy on study and blood sample collection on study, and bone scans, DEXA and CT scans throughout the trial. Patients may also undergo an optional second biopsy at the end of study treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Must be willing to provide informed consent prior to any study specific procedures
- Age >= 18 years
- Documented histologically confirmed adenocarcinoma of the prostate
- Patient must have evidence of castration resistant prostate cancer as evidenced by PSA progression (per Prostate Cancer Working Group 3 [PCWG3] criteria) and a castrate serum testosterone level (i.e., =< 50 mg/dL)
- PSA must be at least 2 ng/ml and rising on two successive measurements at least two weeks apart
Key exclusion criteria (21 listed)
- Involvement in the planning and/or conduct of the study
- Other malignancy unless curatively treated with no evidence of disease for >= 2 years except: adequately treated non-melanoma skin cancer, non-muscle invasive bladder cancer
- Persistent toxicities (Common Terminology Criteria for Adverse Event (CTCAE) grade > 2) caused by previous cancer therapy, excluding alopecia
- Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
- Use of corticosteroids at a dose equivalent to > 10 mg of prednisone daily
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy ProcedureAlso: Biopsy, BIOPSY_TYPE, BxUndergo a biopsy | Procedure or surgery | Cohort IIIa (ADT, testosterone cypionate, LuPSMA), Cohort IIIb (ADT, testosterone cypionate, LuPSMA), Cohort IIIc (ADT, testosterone cypionate, LuPSMA), Cohort IIa (testosterone cypionate, etoposide), Cohort IIb (testosterone cypionate, etoposide), Cohort IIc (testosterone cypionate, etoposide), Cohort Ia (testosterone cypionate, carboplatin), Cohort Ib (testosterone cypionate, carboplatin), Cohort Ic (testosterone cypionate, carboplatin) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Cohort IIIa (ADT, testosterone cypionate, LuPSMA), Cohort IIIb (ADT, testosterone cypionate, LuPSMA), Cohort IIIc (ADT, testosterone cypionate, LuPSMA), Cohort IIa (testosterone cypionate, etoposide), Cohort IIb (testosterone cypionate, etoposide), Cohort IIc (testosterone cypionate, etoposide), Cohort Ia (testosterone cypionate, carboplatin), Cohort Ib (testosterone cypionate, carboplatin), Cohort Ic (testosterone cypionate, carboplatin) |
| Bone ScanAlso: Bone ScintigraphyUndergo bone scan | Procedure or surgery | Cohort IIIa (ADT, testosterone cypionate, LuPSMA), Cohort IIIb (ADT, testosterone cypionate, LuPSMA), Cohort IIIc (ADT, testosterone cypionate, LuPSMA), Cohort IIa (testosterone cypionate, etoposide), Cohort IIb (testosterone cypionate, etoposide), Cohort IIc (testosterone cypionate, etoposide), Cohort Ia (testosterone cypionate, carboplatin), Cohort Ib (testosterone cypionate, carboplatin), Cohort Ic (testosterone cypionate, carboplatin) |
| CarboplatinAlso: Blastocarb, Carboplat, Carboplatin Hexal, CarboplatinoGiven IV | Drug | Cohort Ia (testosterone cypionate, carboplatin), Cohort Ib (testosterone cypionate, carboplatin), Cohort Ic (testosterone cypionate, carboplatin) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Cohort IIIa (ADT, testosterone cypionate, LuPSMA), Cohort IIIb (ADT, testosterone cypionate, LuPSMA), Cohort IIIc (ADT, testosterone cypionate, LuPSMA), Cohort IIa (testosterone cypionate, etoposide), Cohort IIb (testosterone cypionate, etoposide), Cohort IIc (testosterone cypionate, etoposide), Cohort Ia (testosterone cypionate, carboplatin), Cohort Ib (testosterone cypionate, carboplatin), Cohort Ic (testosterone cypionate, carboplatin) |
| EtoposideAlso: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, ToposarGiven PO | Drug | Cohort IIa (testosterone cypionate, etoposide), Cohort IIb (testosterone cypionate, etoposide), Cohort IIc (testosterone cypionate, etoposide) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Cohort IIIa (ADT, testosterone cypionate, LuPSMA), Cohort IIIb (ADT, testosterone cypionate, LuPSMA), Cohort IIIc (ADT, testosterone cypionate, LuPSMA), Cohort IIa (testosterone cypionate, etoposide), Cohort IIb (testosterone cypionate, etoposide), Cohort IIc (testosterone cypionate, etoposide), Cohort Ia (testosterone cypionate, carboplatin), Cohort Ib (testosterone cypionate, carboplatin), Cohort Ic (testosterone cypionate, carboplatin) |
| Questionnaire AdministrationAncillary studies | Other | Cohort IIIa (ADT, testosterone cypionate, LuPSMA), Cohort IIIb (ADT, testosterone cypionate, LuPSMA), Cohort IIIc (ADT, testosterone cypionate, LuPSMA), Cohort IIa (testosterone cypionate, etoposide), Cohort IIb (testosterone cypionate, etoposide), Cohort IIc (testosterone cypionate, etoposide), Cohort Ia (testosterone cypionate, carboplatin), Cohort Ib (testosterone cypionate, carboplatin), Cohort Ic (testosterone cypionate, carboplatin) |
| Testosterone CypionateAlso: depAndro, Depo-Testosterone, Depotest, DepovirinGiven IM | Drug | Cohort IIIa (ADT, testosterone cypionate, LuPSMA), Cohort IIIb (ADT, testosterone cypionate, LuPSMA), Cohort IIIc (ADT, testosterone cypionate, LuPSMA), Cohort IIa (testosterone cypionate, etoposide), Cohort IIb (testosterone cypionate, etoposide), Cohort IIc (testosterone cypionate, etoposide), Cohort Ia (testosterone cypionate, carboplatin), Cohort Ib (testosterone cypionate, carboplatin), Cohort Ic (testosterone cypionate, carboplatin) |
| RadioconjugateAlso: Radio ConjugatesGiven LuPSMA IV | Other | Cohort IIIa (ADT, testosterone cypionate, LuPSMA), Cohort IIIb (ADT, testosterone cypionate, LuPSMA), Cohort IIIc (ADT, testosterone cypionate, LuPSMA) |
| Dual X-ray AbsorptiometryAlso: BMD scan, bone mineral density scan, DEXA, DEXA scanUndergo DEXA | Procedure or surgery | Cohort IIIa (ADT, testosterone cypionate, LuPSMA), Cohort IIIb (ADT, testosterone cypionate, LuPSMA), Cohort IIIc (ADT, testosterone cypionate, LuPSMA), Cohort IIa (testosterone cypionate, etoposide), Cohort IIb (testosterone cypionate, etoposide), Cohort IIc (testosterone cypionate, etoposide), Cohort Ia (testosterone cypionate, carboplatin), Cohort Ib (testosterone cypionate, carboplatin), Cohort Ic (testosterone cypionate, carboplatin) |
| Gallium Ga 68-PSMA-617Also: 2247839-19-4, 68Ga-PSMA-617, Gallium-68 PSMA-617, VIPIVOTIDE TETRAXETAN GALLIUM GA-68Given gallium 68Ga-PSMA-617 | Other | Cohort IIIa (ADT, testosterone cypionate, LuPSMA), Cohort IIIb (ADT, testosterone cypionate, LuPSMA), Cohort IIIc (ADT, testosterone cypionate, LuPSMA) |
| Positron Emission TomographyAlso: Medical Imaging, PET, PET scanUndergo 68Ga-PSMA PET | Procedure or surgery | Cohort IIIa (ADT, testosterone cypionate, LuPSMA), Cohort IIIb (ADT, testosterone cypionate, LuPSMA), Cohort IIIc (ADT, testosterone cypionate, LuPSMA) |
| Single Photon Emission Computed TomographyAlso: Medical Imaging, SPECTUndergo SPECT/CT | Procedure or surgery | Cohort IIIa (ADT, testosterone cypionate, LuPSMA), Cohort IIIb (ADT, testosterone cypionate, LuPSMA), Cohort IIIc (ADT, testosterone cypionate, LuPSMA) |
Primary outcome
Greater than or equal to 50% decline in prostate-specific antigen from baseline (PSA50) response rate
Time frame: From baseline up to 3 years
Will assess >= 50% decline in PSA following treatment with combination bipolar androgen therapy (BAT) and genotoxic chemotherapy (at least 12 weeks of total therapy). Will be calculated as the percentage with 95% confidence interval (CI) of the total number of subjects that achieved a PSA50 response.
6 secondary outcomes
Radiographic response
Time frame: Up to 3 years
Radiographic progression-free survival (PFS)
Time frame: The start of treatment until disease progression (per modified RECIST criteria or PCWG3 criteria for bone lesions), clinical progression (as determined by the treating physician), or death, whichever occurs first, assessed up to 3 years
PSA PFS
Time frame: Time from the start of treatment until PSA progression (as defined by PCWG3 criteria), assessed up to 3 years
Overall survival
Time frame: The start of treatment until death from any cause, assessed up to 3 years
Patient-reported outcome measure (PROMS) questionnaires
Time frame: Up to 3 years
Incidence of adverse events
Time frame: Up to 30 days after completion of study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Schweizer principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Bone Scan in people with Castration-Resistant Prostate Carcinoma and Metastatic Prostate Adenocarcinoma, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Schweizer (206-606-6252, schweize@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Greater than or equal to 50% decline in prostate-specific antigen from baseline (PSA50) response rate (time frame: From baseline up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.