Re-treatment with a radioactive drug for advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial evaluates the effectiveness of re-treatment with 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC) who previously responded well to this therapy. The study aims to assess treatment efficacy, safety, and various survival outcomes after administering up to six additional cycles of the drug. Patients will be monitored for prostate-specific antigen (PSA) response, progression-free survival, and overall survival, along with quality of life assessments. The trial also includes exploratory objectives related to dosimetry in organs affected by the treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• UCLA / Jonsson Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Jeremie Calais, MD — UCLA / Jonsson Comprehensive Cancer Center
• Study coordinator: Stephanie Lira
• Email: StephanieLira@mednet.ucla.edu
• Phone: 3102060596

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.