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RecruitingPhase 2

Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial

Re-Treatment With 177Lu-PSMA-617 Molecular Radiotherapy for Metastatic Castration Resistant Prostate Cancer: A Prospective Phase 2 Trial (RE-LuPSMA STUDY)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: CT scans, Questionnaires, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To determine radiographic progression-free survival (rPFS) according to Response Evaluation Criteria in PSMA positron emission tomography (PET)/computed tomography (CT) (RECIP) criteria."
  • "To determine the impact of re-challenge 177Lu-PSMA-617 therapy on bone pain level, health-related quality of life, and performance status (Eastern Cooperative Oncology Group \[ECOG\]) using established standardized questionnaires."
  • "Patients also receive gallium Ga 68 gozetotide IV and undergo PET/CT at screening and on study, undergo single photon emission computed tomography (SPECT)/CT on study, and undergo collection of blood samples throughout the trial."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests repeat treatment with 177Lu-PSMA-617, a radioactive drug that targets some prostate cancer cells. It is for people whose prostate cancer has spread and keeps growing despite treatment to lower male hormones. Their cancer must have responded well to earlier treatment with this drug.

This phase II trial tests how well re-treatment with 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic), that continues to grow or spread after the surgical removal of the testes or medical treatment to block androgen production (castration-resistant), and that has shown a favorable response to initial treatment with 177Lu-PSMA-617. 177Lu-PSMA-617 is a radioactive drug. It binds to a protein called prostate specific membrane antigen (PSMA), which is expressed by some types of prostate tumor cells. When 177Lu-PSMA-617 binds to PSMA-expressing tumor cells, it delivers radiation to the cells, which may kill them. Re-treatment with 177Lu-PSMA-617 in patients who had a favorable response to initial 177Lu-PSMA-617 treatment may improve survival outcomes and disease response in patients with metastatic castration-resistant prostate cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have prostate cancer that has spread and keeps growing despite surgery or medicine to lower male hormones.
  • Have had chemotherapy for this cancer and at least one medicine that blocks male hormone signals.
  • Have completed at least 4 rounds of 177Lu-PSMA-617.
  • During earlier treatment, PSA—a blood marker for prostate cancer—fell by at least half. No new prostate cancer treatment started within 2 months afterward, except standard hormone-lowering treatment. Treatments already being taken could continue.
  • PSA rose after earlier treatment, confirmed by a second blood test at least 3 weeks later.
  • Have a PSMA PET/CT scan that meets the study rules. It must be done within 8 weeks before repeat treatment and at least 6 weeks after the earlier treatment ended.
  • Have blood counts above these levels: white blood cells 2,500/µL; neutrophils, a type of white blood cell, 1,500/µL; hemoglobin, which carries oxygen, 9.0 g/dL; and platelets, which help stop bleeding, 100,000/µL.
  • Be able to understand and sign the consent form and follow the study rules.

Who can't join

  • Started a new prostate cancer treatment within 2 months after earlier 177Lu-PSMA-617 treatment ended. Standard hormone-lowering treatment is allowed, and treatments already being taken could continue.
  • Had treatment that lowers blood cell production, or another radioactive drug treatment, within the last 6 weeks.
  • Have a kidney filtering test result called creatinine clearance below 50 mL/min.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Patients must have mCRPC * Patients must have received at least one regimen of chemotherapy for mCRPC * Patients must have received at least one androgen receptor signaling inhibitor (ARSI) * Patients must have previously completed at least 4 cycles of 177Lu-PSMA-617 therapy * Patients must have had a favorable response to the first regimen of 177Lu-PSMA-617 therapy defined as: * PSA decline of ≥ 50% at any time during the first regimen of 177Lu-PSMA-617 therapy AND * No new prostate cancer therapy within two months of completing the first regimen of 177Lu-PSMA-617 therapy (first-generation androgen deprivation therapy \[ADT\] is allowed). Concomitant prostate cancer therapy that was administrated during the first regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed * Patients must have had a PSA increase after the first regimen of 177Lu-PSMA-617 therapy, confirmed by a second measurement ≥ 3 weeks apart * Patients must meet PSMA PET/CT VISION criteria. PSMA PET/CT must have been completed within 8 weeks of the planned first cycle of re-challenge 177Lu-PSMA-617 therapy and at least 6 weeks after completion of the first regimen of 177Lu-PSMA-617 therapy * White blood cells \> 2,500 cells/µL * Absolute neutrophil count \> 1,500 cells/µL * Hemoglobin \> 9.0 g/dL * Platelets \> 100,000 cells/µL * Patients must have the ability to understand and sign an approved informed consent form (ICF) and comply with all protocol requirements Exclusion Criteria: * Patient received new prostate cancer therapy within two months of completing the first regimen of 177Lu-PSMA-617 therapy (first-generation ADT (adenosine triphosphate) is allowed). This can include apalutamide, enzalutamide, abiraterone, chemotherapy, immunotherapy, radionuclide therapy, PARP inhibitor, or any biological therapy. Concomitant prostate cancer therapy that was administrated during the first regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed * Patient received myelosuppressive therapy (including docetaxel, cabazitaxel, 223Ra, and 153Sm) or other radionuclide therapy within the last 6 weeks * Patient with creatinine clearance \< 50 mL/min

Study sites (1)

CA