Metastatic Castration-Resistant Prostate CancerPhase 2NCT06972628
Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617
A Phase 2 study testing Administering Lutetium-177-PSMA-617 (PLUVICTO) in people with Metastatic Castration-Resistant Prostate Cancer and Prostate Cancer Patients With Bone Metastasis, run by Ebrahim S Delpassand at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of Lutetium-177-PSMA-617 (PLUVICTO) in patients with metastatic castration-resistant prostate cancer (mCRPC) and extensive bone metastases, which appear as a "super scan" pattern on a bone scan. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-Resistant Prostate Cancer, Prostate Cancer Patients With Bone Metastasis, Prostate Cancer (CRPC)
- What is being tested?
- Administering Lutetium-177-PSMA-617 (PLUVICTO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2025to 1 Apr 2029
- 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
- Ability to understand and sign an informed consent form (ICF).
- Willingness and ability to comply with study requirements.
- Age ≥18 years.
- Presence of skeletal metastases with a superscan pattern on a 99mTc-MDP/HDP bone scan, defined by significantly increased skeletal radioisotope uptake relative to soft tissues and faint or absent renal activity.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Hemoglobin ≥9.0 g/dL.
Show all 14Show fewer
- Platelet count ≥90 × 10⁹/L.
- White blood cell count ≥2.0 × 10⁹/L, absolute neutrophil count (ANC) >1.5 × 10⁹/L.
- o These hematologic criteria must be met without recent transfusions (within 28 days prior to the first study treatment) or growth factor support (within 21 days).
- Serum/plasma creatinine ≤1.5 × upper limit of normal (ULN).
- Histological, pathological, or cytological confirmation of prostate cancer.
- Positive PSMA PET/CT scan showing at least one PSMA-positive metastatic lesion.
- Castrate-level serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
- Prior treatment with at least one androgen receptor-axis-targeted therapy (ARAT).
Who cannot join
- Prior treatment with radiopharmaceuticals (e.g., Strontium-89, Samarium-153, Rhenium- 186, Rhenium-188, Radium-223, hemi-body irradiation) within six months before start of treatment under this protocol.
- Prior PSMA-targeted radioligand therapy.
- Systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, monoclonal antibodies) within four weeks before screening visit.
- Known hypersensitivity to PLUVICTO or its components.
- Concurrent treatment with other cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
- Renal impairment (estimated glomerular filtration rate <60 mL/min), hemoglobin <9 g/dL, ANC <1.5 × 10⁹/L, or platelets < 90 × 10⁹/L.
Show all 11Show fewer
- History of CNS metastases unless treated and stable for 6 months, with no ongoing corticosteroid use.
- Symptomatic or impending spinal cord compression.
- Other malignancies impacting life expectancy or interfering with study assessments. Exceptions include non-melanoma skin cancer or superficial bladder cancer that has been adequately treated.
- Major surgery within 30 days prior to enrollment.
- Plans to conceive or father a child during treatment and up to six months post-treatment.
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
Excel Diagnostics & Nuclear Oncology Center
Houston, Texas, 77042
Susan Cork Therapy Coordinator, 713-781-6200 ext. 3203, scork@exceldiagnostics.com
Nereyda Sauceda, Therapy Coordinator, 713-781-6200 ext. 3246, nsauceda@exceldiagnostics.com
About this study
Official title: 177Lu-PSMA-617 (Pluvicto) for the Treatment of Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Super Scan Bone Scan
The purpose of this study is to evaluate the safety and tolerability of Lutetium-177-PSMA-617 (PLUVICTO) in patients with metastatic castration-resistant prostate cancer (mCRPC) and extensive bone metastases, which appear as a "super scan" pattern on a bone scan.
Pluvicto is FDA-approved, but patients with super scan bone scans were previously excluded from the VISION clinical trial, leaving a knowledge gap.
Read more
The study will enroll up to 30 men with metastatic castration-resistant prostate cancer, with an initial dosing approach that differs from the standard dose.
The safety and tolerability of PLUVICTO will be evaluated in this study, with a focus on identifying the optimal dose for this population.
This study addresses an important gap in understanding how Pluvicto performs in mCRPC patients with super scan findings.
Read the detailed description
This clinical study investigates the safety and effectiveness of the FDA-approved drug Pluvicto (Lu-177-PSMA617).
It focuses on a unique group of patients with metastatic castration-resistant prostate cancer (mCRPC) who present with a "super scan" on bone scintigraphy-a pattern indicating widespread cancer in the bones.
These patients were excluded from prior trials like the VISION study, leaving a critical gap in clinical understanding.
The trial aims to identify the optimal safe dose of Pluvicto using a modified 3+3 dose-escalation method, beginning at a low dose that increases, and eventually reaching up to 200 mCi.
Participants will receive a total of six doses, spaced every 6 ± 1 weeks. Primary objectives include determining the maximum tolerated dose and monitoring safety using CTCAE version 5.0 criteria.
Efficacy will be evaluated through PSA level reductions based on PCWG3 guidelines.
Secondary endpoints include quality of life, radiologic response (RECIST v1.1), and overall survival.
Exploratory endpoints involve PSMA PET/CT imaging to measure treatment response through SUVmean and lesion changes.
The study includes up to 30 participants and will include expanded enrollment once the optimal dose is determined.
Routine lab tests (CBC, CMP, PSA, testosterone) and patient-reported side effects will be monitored throughout the study.
Long-term follow-up for survival and safety will continue every six months for up to five years.
Imaging (CT/MRI, bone scans, and optional PET/CT) will be performed at baseline, mid-treatment, end of treatment, and every three months post-treatment.
A complete or partial response, stable disease, or progression will be defined using both RECIST and PCWG3 guidelines.
Monthly PSA checks will continue for up to 24 months or until disease progression.
PLUVICTO is administered via IV infusion over 2-5 minutes during each session. Participants may discontinue due to progression, intolerable side effects, non-compliance, or other clinical decisions.
This study is essential in determining how to safely extend Pluvicto therapy to a previously unstudied and high-risk patient group.
Its results may expand access to this radioligand therapy and guide future treatment decisions in prostate cancer care.
- Conditions
- Metastatic Castration-Resistant Prostate Cancer, Prostate Cancer Patients With Bone Metastasis, Prostate Cancer (CRPC), Prostate Cancer, Prostate Cancer Metastatic
- Being tested
- Administering Lutetium-177-PSMA-617 (PLUVICTO)
- Keywords
- Metastatic Castration-Resistant Prostate Cancer (mCRPC), super scan bone scan, Prostate Cancer patients with bone metastasis, prostate cancer (CRPC), Prostate cancer, Prostate cancer metastatic
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administering Lutetium-177-PSMA-617 (PLUVICTO)Drug
The study begins with a first cohort of three participants, each receiving a dose of 100 millicuries (mCi). After administration, participants are monitored for any dose-limiting toxicities (DLTs) during a predefined observation window. If fewer than two participants experience a DLT in a given cohort, the dose will be escalated for the next group. The dose escalation schedule is structured as follows: the second cohort receives 130 mCi (a 30% increase), the third cohort receives 162.5 mCi (a 25% increase), and the fourth cohort receives 200 mCi, a dose that is already FDA-approved and clinically accepted for mCRPC. This stepwise escalation continues until the 200 mCi dose is reached, or until two or more DLTs are observed in any cohort. If that occurs, escalation stops immediately, and the maximum tolerated dose is considered to be the previous lower dose. This becomes the optimal tolerated dose (OTD). After identifying the OTD, additional participants will be enrolled for treatment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Drug: Administering Lutetium-177-PSMA-617 (PLUVICTO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic progression-free survival
rPFS: Defined as the time from enrollment to radiographic disease progression, based on Prostate Cancer Working Group 3 (PCWG3) Guidelines (Scher et al., 2016), or death from any cause.
Measured: From date of enrollment until the date of first documented radiographic disease progression or date of death from any cause, whichever came first, assessed up to 24 months.
Overall Survival
OS: Defined as the time from enrollment to death from any cause.
Measured: From date of enrollment until the date of death from any cause, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start23 May 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Metastatic Castration-Resistant Prostate CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study uses an FDA-approved drug (PLUVICTO). Therefore, it is not subject to phase categorization.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ebrahim S Delpassand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ebrahim S Delpassand, Excel Diagnostics and Nuclear Oncology Center
- Investigators
- Ebrahim S. Delpassand, M.D. Chairman & Medical Director, MD., Nuclear Medicine, Principal investigator, Excel Diagnostics & Nuclear Oncology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972628
- Sponsor's protocol ID
- Super-Lu-177
- Status last verified
- May 2025
- First submitted
- 7 Apr 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hartrampf PE, Weinzierl FX, Buck AK, Rowe SP, Higuchi T, Seitz AK, Kubler H, Schirbel A, Essler M, Bundschuh RA, Werner RA. Matched-pair analysis of [177Lu]Lu-PSMA I&T and [177Lu]Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer. Eur J Nucl Med Mol Imaging. 2022 Jul;49(9):3269-3276. doi: 10.1007/s00259-022-05744-6. Epub 2022 Mar 4.
PubMed 35243517Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
PubMed 19097774Banerjee SR, Pullambhatla M, Byun Y, Nimmagadda S, Green G, Fox JJ, Horti A, Mease RC, Pomper MG. 68Ga-labeled inhibitors of prostate-specific membrane antigen (PSMA) for imaging prostate cancer. J Med Chem. 2010 Jul 22;53(14):5333-41. doi: 10.1021/jm100623e.
PubMed 20568777Hope TA, Abbott A, Colucci K, Bushnell DL, Gardner L, Graham WS, Lindsay S, Metz DC, Pryma DA, Stabin MG, Strosberg JR. NANETS/SNMMI Procedure Standard for Somatostatin Receptor-Based Peptide Receptor Radionuclide Therapy with 177Lu-DOTATATE. J Nucl Med. 2019 Jul;60(7):937-943. doi: 10.2967/jnumed.118.230607.
PubMed 31263080Ahmadzadehfar H, Eppard E, Kurpig S, Fimmers R, Yordanova A, Schlenkhoff CD, Gartner F, Rogenhofer S, Essler M. Therapeutic response and side effects of repeated radioligand therapy with 177Lu-PSMA-DKFZ-617 of castrate-resistant metastatic prostate cancer. Oncotarget. 2016 Mar 15;7(11):12477-88. doi: 10.18632/oncotarget.7245.
PubMed 26871285Messiou C, Cook G, deSouza NM. Imaging metastatic bone disease from carcinoma of the prostate. Br J Cancer. 2009 Oct 20;101(8):1225-32. doi: 10.1038/sj.bjc.6605334. Epub 2009 Sep 29.
PubMed 19789531Caglar M, Tuncel M, Yildiz E, Karabulut E. Bone scintigraphy as a gatekeeper for the detection of bone metastases in patients with prostate cancer: comparison with Ga-68 PSMA PET/CT. Ann Nucl Med. 2020 Dec;34(12):932-941. doi: 10.1007/s12149-020-01529-9. Epub 2020 Sep 25.
PubMed 32975741Askari E, Shakeri S, Roustaei H, Fotouhi M, Sadeghi R, Harsini S, Vali R. Superscan Pattern on Bone Scintigraphy: A Comprehensive Review. Diagnostics (Basel). 2024 Oct 6;14(19):2229. doi: 10.3390/diagnostics14192229.
PubMed 39410633Manov JJ, Roth PJ, Kuker R. Clinical Pearls: Etiologies of Superscan Appearance on Fluorine-18-Fludeoxyglucose Positron Emission Tomography-Computed Tomography. Indian J Nucl Med. 2017 Oct-Dec;32(4):259-265. doi: 10.4103/ijnm.IJNM_56_17.
PubMed 29142340Manohar PR, Rather TA, Khan SH, Malik D. Skeletal Metastases Presenting as Superscan on Technetium 99m Methylene Diphosphonate Whole Body Bone Scintigraphy in Different Type of Cancers: A 5-Year Retro-prospective Study. World J Nucl Med. 2017 Jan-Mar;16(1):39-44. doi: 10.4103/1450-1147.181153.
PubMed 28217018
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 177Lu-PSMA-617 (Pluvicto) for the Treatment of Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Super Scan Bone Scan
- ClinicalTrials.gov ID
- NCT06972628
- Acronym / sponsor ID
- Super-Lu-177
- Conditions
- Metastatic Castration-Resistant Prostate Cancer, Prostate Cancer Patients With Bone Metastasis, Prostate Cancer (CRPC), Prostate Cancer, Prostate Cancer Metastatic
- Keywords
- Metastatic Castration-Resistant Prostate Cancer (mCRPC), super scan bone scan, Prostate Cancer patients with bone metastasis, prostate cancer (CRPC), Prostate cancer, Prostate cancer metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ebrahim S DelpassandUniversity, hospital or other
- Study start
- 23 May 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 15 May 2025 (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.
The purpose of this study is to evaluate the safety and tolerability of Lutetium-177-PSMA-617 (PLUVICTO) in patients with metastatic castration-resistant prostate cancer (mCRPC) and extensive bone metastases, which appear as a "super scan" pattern on a bone scan.
Pluvicto is FDA-approved, but patients with super scan bone scans were previously excluded from the VISION clinical trial, leaving a knowledge gap.
The study will enroll up to 30 men with metastatic castration-resistant prostate cancer, with an initial dosing approach that differs from the standard dose.
The safety and tolerability of PLUVICTO will be evaluated in this study, with a focus on identifying the optimal dose for this population.
This study addresses an important gap in understanding how Pluvicto performs in mCRPC patients with super scan findings.
Detailed description
This clinical study investigates the safety and effectiveness of the FDA-approved drug Pluvicto (Lu-177-PSMA617).
It focuses on a unique group of patients with metastatic castration-resistant prostate cancer (mCRPC) who present with a "super scan" on bone scintigraphy-a pattern indicating widespread cancer in the bones.
These patients were excluded from prior trials like the VISION study, leaving a critical gap in clinical understanding.
The trial aims to identify the optimal safe dose of Pluvicto using a modified 3+3 dose-escalation method, beginning at a low dose that increases, and eventually reaching up to 200 mCi.
Participants will receive a total of six doses, spaced every 6 ± 1 weeks. Primary objectives include determining the maximum tolerated dose and monitoring safety using CTCAE version 5.0 criteria.
Efficacy will be evaluated through PSA level reductions based on PCWG3 guidelines.
Secondary endpoints include quality of life, radiologic response (RECIST v1.1), and overall survival.
Exploratory endpoints involve PSMA PET/CT imaging to measure treatment response through SUVmean and lesion changes.
The study includes up to 30 participants and will include expanded enrollment once the optimal dose is determined.
Routine lab tests (CBC, CMP, PSA, testosterone) and patient-reported side effects will be monitored throughout the study.
Long-term follow-up for survival and safety will continue every six months for up to five years.
Imaging (CT/MRI, bone scans, and optional PET/CT) will be performed at baseline, mid-treatment, end of treatment, and every three months post-treatment.
A complete or partial response, stable disease, or progression will be defined using both RECIST and PCWG3 guidelines.
Monthly PSA checks will continue for up to 24 months or until disease progression.
PLUVICTO is administered via IV infusion over 2-5 minutes during each session. Participants may discontinue due to progression, intolerable side effects, non-compliance, or other clinical decisions.
This study is essential in determining how to safely extend Pluvicto therapy to a previously unstudied and high-risk patient group.
Its results may expand access to this radioligand therapy and guide future treatment decisions in prostate cancer care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study uses an FDA-approved drug (PLUVICTO). Therefore, it is not subject to phase categorization.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Administering Lutetium-177-PSMA-617 (PLUVICTO) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Ability to understand and sign an informed consent form (ICF).
- Willingness and ability to comply with study requirements.
- Age ≥18 years.
- Presence of skeletal metastases with a superscan pattern on a 99mTc-MDP/HDP bone scan, defined by significantly increased skeletal radioisotope uptake relative to soft tissues and faint or absent renal activity.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Key exclusion criteria (11 listed)
- Prior treatment with radiopharmaceuticals (e.g., Strontium-89, Samarium-153, Rhenium- 186, Rhenium-188, Radium-223, hemi-body irradiation) within six months before start of treatment under this protocol.
- Prior PSMA-targeted radioligand therapy.
- Systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, monoclonal antibodies) within four weeks before screening visit.
- Known hypersensitivity to PLUVICTO or its components.
- Concurrent treatment with other cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
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 |
|---|---|---|
| Administering Lutetium-177-PSMA-617 (PLUVICTO)The study begins with a first cohort of three participants, each receiving a dose of 100 millicuries (mCi). After administration, participants are monitored for any dose-limiting toxicities (DLTs) during a predefined observation window. If fewer than two participants experience a DLT in a given cohort, the dose will be escalated for the next group. The dose escalation schedule is structured as follows: the second cohort receives 130 mCi (a 30% increase), the third cohort receives 162.5 mCi (a 25% increase), and the fourth cohort receives 200 mCi, a dose that is already FDA-approved and clinically accepted for mCRPC. This stepwise escalation continues until the 200 mCi dose is reached, or until two or more DLTs are observed in any cohort. If that occurs, escalation stops immediately, and the maximum tolerated dose is considered to be the previous lower dose. This becomes the optimal tolerated dose (OTD). After identifying the OTD, additional participants will be enrolled for treatment. | Drug | Treatment Arm |
Primary outcome
Radiographic progression-free survival
Time frame: From date of enrollment until the date of first documented radiographic disease progression or date of death from any cause, whichever came first, assessed up to 24 months.
rPFS: Defined as the time from enrollment to radiographic disease progression, based on Prostate Cancer Working Group 3 (PCWG3) Guidelines (Scher et al., 2016), or death from any cause.
Overall Survival
Time frame: From date of enrollment until the date of death from any cause, assessed up to 24 months.
OS: Defined as the time from enrollment to death from any cause.
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 15 May 2025.
- Background: PubMed 35243517Hartrampf PE, Weinzierl FX, Buck AK, Rowe SP, Higuchi T, Seitz AK, Kubler H, Schirbel A, Essler M, Bundschuh RA, Werner RA. Matched-pair analysis of [177Lu]Lu-PSMA I&T and [177Lu]Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer. Eur J Nucl Med Mol Imaging. 2022 Jul;49(9):3269-3276. doi: 10.1007/s00259-022-05744-6. Epub 2022 Mar 4.
- Background: PubMed 19097774Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
- Background: PubMed 20568777Banerjee SR, Pullambhatla M, Byun Y, Nimmagadda S, Green G, Fox JJ, Horti A, Mease RC, Pomper MG. 68Ga-labeled inhibitors of prostate-specific membrane antigen (PSMA) for imaging prostate cancer. J Med Chem. 2010 Jul 22;53(14):5333-41. doi: 10.1021/jm100623e.
- Background: PubMed 31263080Hope TA, Abbott A, Colucci K, Bushnell DL, Gardner L, Graham WS, Lindsay S, Metz DC, Pryma DA, Stabin MG, Strosberg JR. NANETS/SNMMI Procedure Standard for Somatostatin Receptor-Based Peptide Receptor Radionuclide Therapy with 177Lu-DOTATATE. J Nucl Med. 2019 Jul;60(7):937-943. doi: 10.2967/jnumed.118.230607.
- Background: PubMed 26871285Ahmadzadehfar H, Eppard E, Kurpig S, Fimmers R, Yordanova A, Schlenkhoff CD, Gartner F, Rogenhofer S, Essler M. Therapeutic response and side effects of repeated radioligand therapy with 177Lu-PSMA-DKFZ-617 of castrate-resistant metastatic prostate cancer. Oncotarget. 2016 Mar 15;7(11):12477-88. doi: 10.18632/oncotarget.7245.
- Background: PubMed 19789531Messiou C, Cook G, deSouza NM. Imaging metastatic bone disease from carcinoma of the prostate. Br J Cancer. 2009 Oct 20;101(8):1225-32. doi: 10.1038/sj.bjc.6605334. Epub 2009 Sep 29.
- Background: PubMed 32975741Caglar M, Tuncel M, Yildiz E, Karabulut E. Bone scintigraphy as a gatekeeper for the detection of bone metastases in patients with prostate cancer: comparison with Ga-68 PSMA PET/CT. Ann Nucl Med. 2020 Dec;34(12):932-941. doi: 10.1007/s12149-020-01529-9. Epub 2020 Sep 25.
- Background: PubMed 39410633Askari E, Shakeri S, Roustaei H, Fotouhi M, Sadeghi R, Harsini S, Vali R. Superscan Pattern on Bone Scintigraphy: A Comprehensive Review. Diagnostics (Basel). 2024 Oct 6;14(19):2229. doi: 10.3390/diagnostics14192229.
- Background: PubMed 29142340Manov JJ, Roth PJ, Kuker R. Clinical Pearls: Etiologies of Superscan Appearance on Fluorine-18-Fludeoxyglucose Positron Emission Tomography-Computed Tomography. Indian J Nucl Med. 2017 Oct-Dec;32(4):259-265. doi: 10.4103/ijnm.IJNM_56_17.
- Background: PubMed 28217018Manohar PR, Rather TA, Khan SH, Malik D. Skeletal Metastases Presenting as Superscan on Technetium 99m Methylene Diphosphonate Whole Body Bone Scintigraphy in Different Type of Cancers: A 5-Year Retro-prospective Study. World J Nucl Med. 2017 Jan-Mar;16(1):39-44. doi: 10.4103/1450-1147.181153.
- American Cancer Society . Cancer Facts and Statistics: American Cancer Society. 2015Link provided by the sponsor.
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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.
Ebrahim S. Delpassand, M.D. Chairman & Medical Director, MD., Nuclear Medicine principal investigator
Excel Diagnostics & Nuclear Oncology Center
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 Administering Lutetium-177-PSMA-617 (PLUVICTO) in people with Metastatic Castration-Resistant Prostate Cancer and Prostate Cancer Patients With Bone Metastasis, run by Ebrahim S Delpassand 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 14 inclusion and 11 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 15 May 2025. 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 Susan Cork Therapy Coordinator (713-781-6200 ext. 3203, scork@exceldiagnostics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic progression-free survival (time frame: From date of enrollment until the date of first documented radiographic disease progression or date of death from any cause, whichever came first, assessed up to 24 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?
On the ClinicalTrials.gov record for NCT06972628, which also lists 10 linked publications.
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 15 May 2025.