Castration-Sensitive Prostate CarcinomaPhase 2NCT06244004
FDG-PET-Guided Metastasis Directed Radiation Therapy for the Treatment of Metastatic Hormone Sensitive Prostate Cancer, The PRTY Trial
A Phase 2 study testing Antiandrogen Therapy, Bone Scan and Computed Tomography in people with Castration-Sensitive Prostate Carcinoma and Metastatic Prostate Carcinoma, run by Northwestern University at 6 sites in United States.
Trial summary
This phase II trial compares the effect of FDG-positron emission tomography (PET)-guided metastasis directed radiation therapy (MDRT) in combination with standard treatments to standard treatments alone in treating patients with prostate cancer that is sensitive to androgen-deprivation therapy (ADT) and has spread… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
- What is being tested?
- Antiandrogen Therapy, Bone Scan and Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Feb 2024to 18 Feb 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
- Patients must have metastatic prostate cancer on conventional imaging (CT scan, MRI, and/or bone scan).
- Note; Patients who had metastatic disease on conventional imaging prior to beginning ADT, but which has now resolved, are still eligible if they meet remaining eligibility criteria
- Patients must be ≥ 18 years of age at the time of informed consent.
- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- Planned treatment requirements:
- Cohort 1
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- Patients must have mHSPC and be planning therapy with cytotoxic therapy, with or without an androgen receptor (AR) pathway inhibitor (ARPI), to be eligible for Cohort 1. Patients may also enroll if they are currently receiving or have completed cytotoxic therapy, if they are within 26 weeks +/- 4 weeks (30 weeks) of starting cytotoxic therapy and 26 weeks +/- 26 weeks (one year) of starting ADT.
- Note:
- Typically cytotoxic therapy means docetaxel. Patients planning other cytotoxic therapy (e.g. cabazitaxel) should discuss this with the study principal investigator (PI).
- If a patient registers as part of cohort 1 but ends up not receiving any cytotoxic therapy, the patient may be switched to cohort 2. This must be discussed with the study PI. If the patient received at least one cycle of cytotoxic therapy, they would remain in cohort 1.
- Patients will continue their standard of care treatment while on study (plus MDRT if they are on Arm 1A). Change in standard of care therapy will be allowed for toxicity or for de-escalation, and the patient will remain on study. Change in therapy for progression is considered a progression event.
- Cohort 2
- Patients must have mHSPC and be planning therapy with androgen deprivation therapy (ADT), with or without an ARPI, and not planning cytotoxic therapy, to be eligible for Cohort 2. Patients may also enroll if they are within 26 weeks +/- 4 weeks (30 weeks) of starting an AR pathway inhibitor and 26 weeks +/- 26 weeks (one year) of starting ADT.
- Note:
- If patients register as part of cohort 2 but end up receiving one or more cycles of cytotoxic therapy, they may be switched to cohort 1. This must be discussed with the study PI.
- Patients will continue their standard of care treatment while on study (plus MDRT if they are on Arm 2A). If they switch therapy because of progression, they will be considered to have progressed.
- Patients can be enrolled anytime within the initial ~6 month standard of care time period, though early enrollment is preferred. Screening can take place prior to starting standard of care (SOC) therapy or during standard of care therapy, as long as they are within 30 weeks of starting therapy.
- Leukocytes (WBC) ≥ 2,500/mcL (growth factor use allowed) (obtained prior to registration).
- Absolute neutrophil count (ANC) ≥ 1,500/mcL (growth factor use allowed) (obtained prior to registration).
- Platelets (PLT) ≥ 80,000/mcL (transfusions allowed) (obtained prior to registration).
- Patient must be able to lie flat and still for approximately 15-20 minutes AND able to tolerate FDG-PET/CT radiographical imaging and radiation treatment planning and delivery.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the endpoints for this study, in the opinion of the treating investigator, are eligible.
- Note; Patients are ineligible if another known malignancy makes it difficult to interpret if FDG-avid lesions represent prostate cancer, or if the malignancy is expected to interfere with patients receiving standard therapy for prostate cancer for 2 years from study enrollment.
- Patients must have a life expectancy of at least 6 months, in the opinion of the treating investigator.
- Patients must have the ability to understand and the willingness to sign a written informed consent document prior to registration.
- Note: Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
Who cannot join
- Patients with prostate cancer that is castration resistant, which is defined as two consecutive rising PSA values despite testosterone level < 50 ng/dL.
- Patients who started androgen deprivation therapy (ADT) more than 26 weeks +/- 26 weeks (1 year) prior to enrollment.
- Note: ADT is defined as luteinizing hormone-releasing hormone (LHRH) agonist (e.g. leuprolide, goserelin) or antagonist (e.g. degarelix, relugolix) or surgical castration. Bicalutamide 50 mg daily does not count as ADT.
- Note: Patients will not be excluded if they were previously on intermittent therapy, as long as the current "on" period started within one year of enrollment.
- Patients who started intensification of therapy beyond ADT (e.g., AR pathway inhibitor, cytotoxic therapy) more than 26 weeks +/- 4 weeks (30 weeks) prior to registration.
- Note: First generation antiandrogens (bicalutamide) are not considered intensification of therapy beyond ADT.
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- Subjects with a known allergy to contrast material and/or contraindication to FDG-PET
- Note: Contrast allergies: Patients with a known allergy to imaging contrast agent(s) are eligible, provided prior reactions have not been severe, and the patient is willing and able to receive pre-medications and/or supportive care according to institutional standard practice (e.g., corticosteroids, antihistamines, etc.) to manage reactions adequately.
- Patients who are enrolled in another therapeutic clinical trial that would preclude them from participating in this trial.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
David VanderWeele, 312-926-2413, david.vanderweele@northwestern.edu
David VanderWeele
- Recruiting
Northwestern Medicine: Kishwaukee
DeKalb, Illinois, 60115
Study Coordinator, 3126951301, cancer@northwestern.edu
David VanderWeele, MD, PHD
- Recruiting
Northwestern Medicine: Delnor
Geneva, Illinois, 60134
Study Coordinator, 3126951301, cancer@northwestern.edu
David VanderWeele, M
- Recruiting
Northwestern University Oak Brook IL453
Oak Brook, Illinois, 60523
Study Coordinator, MD, PhD, (331) 732-4490, cancer@northwestern.edu
David VanderWeele, MD, PhD
- Not yet recruiting
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
Study Coordinator, 3126951301, cancer@northwestern.edu
David VanderWeele, MD, PhD
- Recruiting
Northwestern Medicine: Warrenville
Warrenville, Illinois, 60555
Study Coordinator, 3126951301, cancer@northwestern.edu
David VanderWeele, MD, PhD
About this study
Official title: A Randomized Open Label Phase II Trial of FDG-PET-Guided Metastasis Directed Therapy in Patients With Metastatic Hormone Sensitive Prostate Cancer: PRTY Trial: PET- Guided Radiotherapy Consolidation
This phase II trial compares the effect of FDG-positron emission tomography (PET)-guided metastasis directed radiation therapy (MDRT) in combination with standard treatments to standard treatments alone in treating patients with prostate cancer that is sensitive to androgen-deprivation therapy (ADT) and has spread from where it first started (primary site) to other places in the body (metastatic). Prostate cancer is the second leading cause of cancer death among men in the United States, despite the approval of several life-prolonging treatments by the Food and Drug Administration. However, over the past 10 years, there have been significant improvements in prolonging the lives of those with metastatic hormone sensitive prostate cancer, specifically by adding treatments to standard therapy, such as ADT. More recently, trials have demonstrated a benefit of using radiotherapy (high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors) to delay the progression of cancer and prolong life for patients with metastatic disease. Imaging scans with FDG-PET may be able to identify cancer sites that remain active despite standard treatment. Giving MDRT plus standard treatment to patients with FDG-PET-identified cancer sites may work better than standard treatment alone in treating metastatic hormone sensitive prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare the progression free survival (PFS) between standard of care (SOC) + MDRT (Arm 1A) versus (vs) SOC alone (Arm 1B). (Cohort 1 [cytotoxic therapy cohort]) II. To compare the proportions of patients in Arm 2A vs Arm 2B who attain complete response (CR) 6 months after randomization. (Cohort 2 [non-cytotoxic therapy cohort])
SECONDARY OBJECTIVES:
- To compare the radiographic progression-free survival (rPFS) between Arms 1A and 1B. (Cohort 1 [cytotoxic therapy cohort]) II. To determine the proportions of patients with metastatic hormone sensitive prostate cancer (mHSPC) who achieve a serum prostate-specific antigen (PSA) level < 4 ng/mL and < 0.01 ng/mL and compare them between Arm 1A and 1B. (Cohort 1 [cytotoxic therapy cohort]) III. To determine the proportion of patients with skeletal related events (SRE), and compare them between Arms 1A and 1B. (Cohort 1 [cytotoxic therapy cohort]) IV. To assess the safety and toxicity of MDRT during and following MDRT completion. (Cohort 1 [cytotoxic therapy cohort]) V. To determine the objective response rate (ORR), defined as the proportion of patients who experience a confirmed complete response (CR) or confirmed partial response (PR) on fludeoxyglucose F-18 (FDG)-PET-2, and to compare ORR between Arms 2A and 2B. (Cohort 2 [non-cytotoxic therapy cohort]) VI. To determine the progression-free survival (PFS) and radiographic progression-free survival (rPFS), and to compare between Arms 2A and 2B. (Cohort 2 [non-cytotoxic therapy cohort]) VII. To determine the proportions of patients with mHSPC who achieve a serum PSA level < 4 ng/mL and < 0.01 ng/mL (undetectable), and compare them between Arms 2A and 2B. (Cohort 2 [non-cytotoxic therapy cohort]) VIII. To determine the proportion of patients with skeletal related events (SRE), and compare them between Arms 2A and 2B. (Cohort 2 [non-cytotoxic therapy cohort]) IX. To assess the safety and toxicity of MDRT during and following MDRT completion. (Cohort 2 [non-cytotoxic therapy cohort])
EXPLORATORY OBJECTIVES:
- To examine association between imaging features and progression free survival (Cohort 1) or likelihood of response (Cohort 2).
II. To determine the time to treatment discontinuation (TTD) in Cohort 1 Arm 1A, 1B, and 1C, and Cohort 2 Arms 2A, 2B and 2C.
OUTLINE: Patients undergoing cytotoxic chemotherapy are assigned to Cohort 1, while patients not undergoing cytotoxic chemotherapy are assigned to Cohort 2.
COHORT 1: Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + androgen deprivation therapy (ADT). Patients with PET-avid disease are randomized to Arm 1A or 1B. Patients without PET-avid disease are assigned to Arm 1C.
ARM 1A: Patients continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients also undergo computed tomography (CT) and bone scans throughout the trial.
ARM 1B: Patients continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial.
ARM 1C: Patients continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial.
COHORT 2: Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients with PET-avid disease are randomized to Arm 2A or 2B. Patients without PET-avid disease are assigned to Arm 2C.
ARM 2A: Patients continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.
ARM 2B: Patients continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.
ARM 2C: Patients continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.
After completion of study treatment, patients are followed up at 3 months (Arms 1A, 1B, 2A, 2B only) and 6 months, and then every 6 months until 36 months.
- Conditions
- Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
- Being tested
- Antiandrogen Therapy, Bone Scan, Computed Tomography, Cytotoxic Chemotherapy, FDG-Positron Emission 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.
Antiandrogen TherapyDrug
Also called ADT, Androgen Deprivation Therapy, Androgen Deprivation Therapy (ADT), Anti-androgen Therapy
Undergo SOC ADT
Bone ScanProcedure or surgery
Also called Bone Scintigraphy
Undergo bone scan
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Cytotoxic ChemotherapyDrug
Also called Cytotoxic, Cytotoxic Therapy
Receive SOC cytotoxic chemotherapy
FDG-Positron Emission TomographyProcedure or surgery
Also called FDG, FDG-PET, FDG-PET Imaging
Undergo FDG-PET
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate
Undergo MDRT
| Study group | Role | What they receive |
|---|---|---|
| Arm 1A (FDG-PET, MDRT, SOC cytotoxic chemotherapy & ADT) | Experimental | Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients with PET-avid disease continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients also undergo CT and bone scans throughout the trial. Receives: Drug: Antiandrogen Therapy; Procedure: Bone Scan; Procedure: Computed Tomography; Drug: Cytotoxic Chemotherapy; Procedure: FDG-Positron Emission Tomography; Radiation: Radiation Therapy |
| Arm 1B (FDG-PET, SOC cytotoxic chemotherapy & ADT) | Active comparator | Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients with PET-avid disease continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial. Receives: Drug: Antiandrogen Therapy; Procedure: Bone Scan; Procedure: Computed Tomography; Drug: Cytotoxic Chemotherapy; Procedure: FDG-Positron Emission Tomography |
| Arm 1C (FDG-PET, SOC cytotoxic chemotherapy & ADT) | Active comparator | Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients without PET-avid disease continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial. Receives: Drug: Antiandrogen Therapy; Procedure: Bone Scan; Procedure: Computed Tomography; Drug: Cytotoxic Chemotherapy; Procedure: FDG-Positron Emission Tomography |
| Arm 2A (FDG-PET, MDRT, SOC ADT) | Experimental | Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients with PET-avid disease continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial. Receives: Drug: Antiandrogen Therapy; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: FDG-Positron Emission Tomography; Radiation: Radiation Therapy |
| Arm 2B (FDG-PET, SOC ADT) | Active comparator | Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients with PET-avid disease continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial. Receives: Drug: Antiandrogen Therapy; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: FDG-Positron Emission Tomography |
| Arm 2C (FDG-PET, SOC ADT) | Active comparator | Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients without PET-avid disease continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial. Receives: Drug: Antiandrogen Therapy; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: FDG-Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) (Cohort 1)
Will be estimated using the method of Kaplan-Meier and compared between treatment arms (Arms 1A and 1B) using the log-rank test. PFS rate at 18 months following randomization will be estimated and reported with the corresponding confidence intervals.
Measured: From randomization to first radiographic or prostate-specific antigen (PSA)-based disease progression, or death, assessed up to 36 months
Complete response rate (Cohort 2)
Will be estimated as the proportion of patients who demonstrate response based on fludeoxyglucose F-18-positron emission tomography (FDG-PET)-2 as compared to baseline (FDG-PET-1), and will be reported with the corresponding Clopper-Pearson confidence intervals. Response rates will be compared between Arms 2A and 2B using Fisher's exact test.
Measured: At 6 months
Secondary outcomes (10)
Radiographic PFS (rPFS) (Cohort 1)
Will be estimated using the method of Kaplan-Meier and compared between treatment arms (Arms 1A and 1B) using the log-rank test. rPFS rate at 18 months following randomization will be estimated and reported with the corresponding confidence intervals.
Measured: From randomization until disease progression on computed tomography (CT) and/or bone scan, or death from any cause, assessed up to 36 months
Proportions of patients with metastatic hormone sensitive prostate cancer (mHSPC) who achieve a serum PSA level < 0.4 ng/mL and < 0.01 ng/mL (Cohort 1)
Will be compared using the Fisher's exact test, and estimates by arm will be reported with the corresponding Clopper-Pearson confidence intervals.
Measured: Up to 36 months
Proportion of patients with Skeletal Related Events (SRE) (Cohort 1)
Will be compared using the Fisher's exact test, and estimates by arm will be reported with the corresponding Clopper-Pearson confidence intervals.
Measured: Up to 36 months
Incidence of adverse events (AEs) of metastasis directed radiation therapy (MDRT) (Cohort 1)
Will be summarized by arm using the Common Terminology Criteria in Adverse Events (CTCAE) version (v) 5.0 system organ class and term. For each subject, highest AE grade across multiple occurrences of the same event will be recorded, and the number of patients will be summarized by AE type and grade.
Measured: Up to 36 months
Objective response rate (Cohort 2)
Defined as the proportion of patients who experience a complete response or partial response on FDG-PET-2. Will be summarized by arm and compared between Arms 2A and 2B.
Measured: Up to 36 months
PFS (Cohort 2)
Will be estimated using the method of Kaplan-Meier and compared between treatment arms (Arms 2A and 2B) using the log-rank test. PFS and rate at key time points, e.g. 6 and 18 months following randomization, will be estimated and reported with the corresponding confidence intervals.
Measured: From randomization to first radiographic or PSA-based disease progression, or death, assessed up to 36 months
rPFS (Cohort 2)
Will be estimated using the method of Kaplan-Meier and compared between treatment arms (Arms 2A and 2B) using the log-rank test. rPFS at key time points, e.g. 6 and 18 months following randomization, will be estimated and reported with the corresponding confidence intervals.
Measured: From randomization until disease progression on CT and/or bone scan, or death from any cause, assessed up to 36 months
Proportions of patients with mHSPC who achieve a serum PSA level < 0.4 ng/mL and < 0.01 ng/mL (Cohort 2)
Will be summarized by arm and compared between Arms 2A and 2B.
Measured: Up to 36 months
Proportion of patients with SREs (Cohort 2)
Will be summarized by arm and compared between Arms 2A and 2B.
Measured: Up to 36 months
Incidence of AEs of MDRT (Cohort 2)
Will report frequency of adverse events by grade ≥ 2 assessed according to the CTCAE v 5.0.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start18 Feb 2024
- Primary completion18 Feb 2027 (estimated)
- Study completion18 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration-Sensitive Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David VanderWeele, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244004
- Sponsor's protocol ID
- NU 23U09
- Other IDs
- NCI-2023-10764, STU00220350, NU 23U09, P30CA060553
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open Label Phase II Trial of FDG-PET-Guided Metastasis Directed Therapy in Patients With Metastatic Hormone Sensitive Prostate Cancer: PRTY Trial: PET- Guided Radiotherapy Consolidation
- ClinicalTrials.gov ID
- NCT06244004
- Acronym / sponsor ID
- NU 23U09
- Conditions
- Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 18 Feb 2027 (estimated)
- Study completion
- 18 Feb 2028 (estimated)
- First posted
- 6 Feb 2024 (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 compares the effect of FDG-positron emission tomography (PET)-guided metastasis directed radiation therapy (MDRT) in combination with standard treatments to standard treatments alone in treating patients with prostate cancer that is sensitive to androgen-deprivation therapy (ADT) and has spread from where it first started (primary site) to other places in the body (metastatic). Prostate cancer is the second leading cause of cancer death among men in the United States, despite the approval of several life-prolonging treatments by the Food and Drug Administration. However, over the past 10 years, there have been significant improvements in prolonging the lives of those with metastatic hormone sensitive prostate cancer, specifically by adding treatments to standard therapy, such as ADT. More recently, trials have demonstrated a benefit of using radiotherapy (high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors) to delay the progression of cancer and prolong life for patients with metastatic disease. Imaging scans with FDG-PET may be able to identify cancer sites that remain active despite standard treatment. Giving MDRT plus standard treatment to patients with FDG-PET-identified cancer sites may work better than standard treatment alone in treating metastatic hormone sensitive prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
- To compare the progression free survival (PFS) between standard of care (SOC) + MDRT (Arm 1A) versus (vs) SOC alone (Arm 1B). (Cohort 1 [cytotoxic therapy cohort]) II. To compare the proportions of patients in Arm 2A vs Arm 2B who attain complete response (CR) 6 months after randomization. (Cohort 2 [non-cytotoxic therapy cohort])
SECONDARY OBJECTIVES:
- To compare the radiographic progression-free survival (rPFS) between Arms 1A and 1B. (Cohort 1 [cytotoxic therapy cohort]) II. To determine the proportions of patients with metastatic hormone sensitive prostate cancer (mHSPC) who achieve a serum prostate-specific antigen (PSA) level < 4 ng/mL and < 0.01 ng/mL and compare them between Arm 1A and 1B. (Cohort 1 [cytotoxic therapy cohort]) III. To determine the proportion of patients with skeletal related events (SRE), and compare them between Arms 1A and 1B. (Cohort 1 [cytotoxic therapy cohort]) IV. To assess the safety and toxicity of MDRT during and following MDRT completion. (Cohort 1 [cytotoxic therapy cohort]) V. To determine the objective response rate (ORR), defined as the proportion of patients who experience a confirmed complete response (CR) or confirmed partial response (PR) on fludeoxyglucose F-18 (FDG)-PET-2, and to compare ORR between Arms 2A and 2B. (Cohort 2 [non-cytotoxic therapy cohort]) VI. To determine the progression-free survival (PFS) and radiographic progression-free survival (rPFS), and to compare between Arms 2A and 2B. (Cohort 2 [non-cytotoxic therapy cohort]) VII. To determine the proportions of patients with mHSPC who achieve a serum PSA level < 4 ng/mL and < 0.01 ng/mL (undetectable), and compare them between Arms 2A and 2B. (Cohort 2 [non-cytotoxic therapy cohort]) VIII. To determine the proportion of patients with skeletal related events (SRE), and compare them between Arms 2A and 2B. (Cohort 2 [non-cytotoxic therapy cohort]) IX. To assess the safety and toxicity of MDRT during and following MDRT completion. (Cohort 2 [non-cytotoxic therapy cohort])
EXPLORATORY OBJECTIVES:
- To examine association between imaging features and progression free survival (Cohort 1) or likelihood of response (Cohort 2).
II. To determine the time to treatment discontinuation (TTD) in Cohort 1 Arm 1A, 1B, and 1C, and Cohort 2 Arms 2A, 2B and 2C.
OUTLINE: Patients undergoing cytotoxic chemotherapy are assigned to Cohort 1, while patients not undergoing cytotoxic chemotherapy are assigned to Cohort 2.
COHORT 1: Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + androgen deprivation therapy (ADT). Patients with PET-avid disease are randomized to Arm 1A or 1B. Patients without PET-avid disease are assigned to Arm 1C.
ARM 1A: Patients continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients also undergo computed tomography (CT) and bone scans throughout the trial.
ARM 1B: Patients continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial.
ARM 1C: Patients continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial.
COHORT 2: Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients with PET-avid disease are randomized to Arm 2A or 2B. Patients without PET-avid disease are assigned to Arm 2C.
ARM 2A: Patients continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.
ARM 2B: Patients continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.
ARM 2C: Patients continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.
After completion of study treatment, patients are followed up at 3 months (Arms 1A, 1B, 2A, 2B only) and 6 months, and then every 6 months until 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1A (FDG-PET, MDRT, SOC cytotoxic chemotherapy & ADT) | Experimental | Drug: Antiandrogen Therapy, Procedure: Bone Scan, Procedure: Computed Tomography, Drug: Cytotoxic Chemotherapy, Procedure: FDG-Positron Emission Tomography, Radiation: Radiation TherapyPatients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients with PET-avid disease continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients also undergo CT and bone scans throughout the trial. |
| Arm 1B (FDG-PET, SOC cytotoxic chemotherapy & ADT) | Active comparator | Drug: Antiandrogen Therapy, Procedure: Bone Scan, Procedure: Computed Tomography, Drug: Cytotoxic Chemotherapy, Procedure: FDG-Positron Emission TomographyPatients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients with PET-avid disease continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial. |
| Arm 1C (FDG-PET, SOC cytotoxic chemotherapy & ADT) | Active comparator | Drug: Antiandrogen Therapy, Procedure: Bone Scan, Procedure: Computed Tomography, Drug: Cytotoxic Chemotherapy, Procedure: FDG-Positron Emission TomographyPatients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients without PET-avid disease continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial. |
| Arm 2A (FDG-PET, MDRT, SOC ADT) | Experimental | Drug: Antiandrogen Therapy, Procedure: Bone Scan, Procedure: Computed Tomography, Procedure: FDG-Positron Emission Tomography, Radiation: Radiation TherapyPatients undergo an FDG-PET scan after 6 months of SOC ADT. Patients with PET-avid disease continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial. |
| Arm 2B (FDG-PET, SOC ADT) | Active comparator | Drug: Antiandrogen Therapy, Procedure: Bone Scan, Procedure: Computed Tomography, Procedure: FDG-Positron Emission TomographyPatients undergo an FDG-PET scan after 6 months of SOC ADT. Patients with PET-avid disease continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial. |
| Arm 2C (FDG-PET, SOC ADT) | Active comparator | Drug: Antiandrogen Therapy, Procedure: Bone Scan, Procedure: Computed Tomography, Procedure: FDG-Positron Emission TomographyPatients undergo an FDG-PET scan after 6 months of SOC ADT. Patients without PET-avid disease continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Patients must have metastatic prostate cancer on conventional imaging (CT scan, MRI, and/or bone scan).
- Patients must be ≥ 18 years of age at the time of informed consent.
- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- Planned treatment requirements:
- Leukocytes (WBC) ≥ 2,500/mcL (growth factor use allowed) (obtained prior to registration).
Key exclusion criteria (9 listed)
- Patients with prostate cancer that is castration resistant, which is defined as two consecutive rising PSA values despite testosterone level < 50 ng/dL.
- Patients who started androgen deprivation therapy (ADT) more than 26 weeks +/- 26 weeks (1 year) prior to enrollment.
- Patients who started intensification of therapy beyond ADT (e.g., AR pathway inhibitor, cytotoxic therapy) more than 26 weeks +/- 4 weeks (30 weeks) prior to registration.
- Subjects with a known allergy to contrast material and/or contraindication to FDG-PET
- Patients who are enrolled in another therapeutic clinical trial that would preclude them from participating in this trial.
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 |
|---|---|---|
| Antiandrogen TherapyAlso: ADT, Androgen Deprivation Therapy, Androgen Deprivation Therapy (ADT), Anti-androgen TherapyUndergo SOC ADT | Drug | Arm 1A (FDG-PET, MDRT, SOC cytotoxic chemotherapy & ADT), Arm 1B (FDG-PET, SOC cytotoxic chemotherapy & ADT), Arm 1C (FDG-PET, SOC cytotoxic chemotherapy & ADT), Arm 2A (FDG-PET, MDRT, SOC ADT), Arm 2B (FDG-PET, SOC ADT), Arm 2C (FDG-PET, SOC ADT) |
| Bone ScanAlso: Bone ScintigraphyUndergo bone scan | Procedure or surgery | Arm 1A (FDG-PET, MDRT, SOC cytotoxic chemotherapy & ADT), Arm 1B (FDG-PET, SOC cytotoxic chemotherapy & ADT), Arm 1C (FDG-PET, SOC cytotoxic chemotherapy & ADT), Arm 2A (FDG-PET, MDRT, SOC ADT), Arm 2B (FDG-PET, SOC ADT), Arm 2C (FDG-PET, SOC ADT) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Arm 1A (FDG-PET, MDRT, SOC cytotoxic chemotherapy & ADT), Arm 1B (FDG-PET, SOC cytotoxic chemotherapy & ADT), Arm 1C (FDG-PET, SOC cytotoxic chemotherapy & ADT), Arm 2A (FDG-PET, MDRT, SOC ADT), Arm 2B (FDG-PET, SOC ADT), Arm 2C (FDG-PET, SOC ADT) |
| Cytotoxic ChemotherapyAlso: Cytotoxic, Cytotoxic TherapyReceive SOC cytotoxic chemotherapy | Drug | Arm 1A (FDG-PET, MDRT, SOC cytotoxic chemotherapy & ADT), Arm 1B (FDG-PET, SOC cytotoxic chemotherapy & ADT), Arm 1C (FDG-PET, SOC cytotoxic chemotherapy & ADT) |
| FDG-Positron Emission TomographyAlso: FDG, FDG-PET, FDG-PET ImagingUndergo FDG-PET | Procedure or surgery | Arm 1A (FDG-PET, MDRT, SOC cytotoxic chemotherapy & ADT), Arm 1B (FDG-PET, SOC cytotoxic chemotherapy & ADT), Arm 1C (FDG-PET, SOC cytotoxic chemotherapy & ADT), Arm 2A (FDG-PET, MDRT, SOC ADT), Arm 2B (FDG-PET, SOC ADT), Arm 2C (FDG-PET, SOC ADT) |
| Radiation TherapyAlso: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, IrradiateUndergo MDRT | Radiation | Arm 1A (FDG-PET, MDRT, SOC cytotoxic chemotherapy & ADT), Arm 2A (FDG-PET, MDRT, SOC ADT) |
Primary outcome
Progression free survival (PFS) (Cohort 1)
Time frame: From randomization to first radiographic or prostate-specific antigen (PSA)-based disease progression, or death, assessed up to 36 months
Will be estimated using the method of Kaplan-Meier and compared between treatment arms (Arms 1A and 1B) using the log-rank test. PFS rate at 18 months following randomization will be estimated and reported with the corresponding confidence intervals.
Complete response rate (Cohort 2)
Time frame: At 6 months
Will be estimated as the proportion of patients who demonstrate response based on fludeoxyglucose F-18-positron emission tomography (FDG-PET)-2 as compared to baseline (FDG-PET-1), and will be reported with the corresponding Clopper-Pearson confidence intervals. Response rates will be compared between Arms 2A and 2B using Fisher's exact test.
10 secondary outcomes
Radiographic PFS (rPFS) (Cohort 1)
Time frame: From randomization until disease progression on computed tomography (CT) and/or bone scan, or death from any cause, assessed up to 36 months
Proportions of patients with metastatic hormone sensitive prostate cancer (mHSPC) who achieve a serum PSA level < 0.4 ng/mL and < 0.01 ng/mL (Cohort 1)
Time frame: Up to 36 months
Proportion of patients with Skeletal Related Events (SRE) (Cohort 1)
Time frame: Up to 36 months
Incidence of adverse events (AEs) of metastasis directed radiation therapy (MDRT) (Cohort 1)
Time frame: Up to 36 months
Objective response rate (Cohort 2)
Time frame: Up to 36 months
PFS (Cohort 2)
Time frame: From randomization to first radiographic or PSA-based disease progression, or death, assessed up to 36 months
rPFS (Cohort 2)
Time frame: From randomization until disease progression on CT and/or bone scan, or death from any cause, assessed up to 36 months
Proportions of patients with mHSPC who achieve a serum PSA level < 0.4 ng/mL and < 0.01 ng/mL (Cohort 2)
Time frame: Up to 36 months
Proportion of patients with SREs (Cohort 2)
Time frame: Up to 36 months
Incidence of AEs of MDRT (Cohort 2)
Time frame: Up to 36 months
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 8 Oct 2026.
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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.
David VanderWeele, MD, PhD principal investigator
Northwestern University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antiandrogen Therapy, Bone Scan and Computed Tomography in people with Castration-Sensitive Prostate Carcinoma and Metastatic Prostate Carcinoma, run by Northwestern University at 6 sites 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 26 inclusion and 9 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 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 Study Coordinator (13126959367, cancer@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (Cohort 1) (time frame: From randomization to first radiographic or prostate-specific antigen (PSA)-based disease progression, or death, assessed up to 36 months). The study lists 2 primary outcomes in all. 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 8 Oct 2026.