Phase 2 Study on Flexible Dosing of 177Lu-PSMA-617 for Treating Advanced Prostate Cancer

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06216249

Provider View

This clinical trial is exploring a flexible dosing schedule of the drug 177Lu-PSMA-617 for men with advanced prostate cancer that has spread and is resistant to standard hormone therapy. The study compares a flexible schedule with a fixed schedule to see which is more effective and safer.

Patient Parameters

Program Overview

The study aims to find out if a flexible dosing schedule of the drug 177Lu-PSMA-617, which includes possible breaks in treatment, can improve survival in men with advanced prostate cancer. This flexible approach is compared to a standard fixed schedule of treatment every 6 weeks. The flexible schedule is adjusted based on how the cancer responds to the treatment, as seen in scans.

Description

The main goal of this study is to see if a flexible dosing schedule of the drug 177Lu-PSMA-617 can help men with advanced prostate cancer live longer. This schedule allows for up to 12 treatment cycles and includes possible breaks, depending on how the cancer responds. The study will also look at the safety of this flexible schedule and compare it to the standard schedule of 6 treatment cycles every 6 weeks.

Other goals include comparing how long patients live without the cancer getting worse, the overall control of the disease, the impact on bone pain, and the quality of life between the two schedules. The study will also explore how the drug is distributed in the body and its effects on organs and tumors.

Participants are divided into two groups:

  • Group 1: Receives 177Lu-PSMA-617 every 6 weeks, with the possibility of extending the time between treatments based on response. This can continue for up to 12 cycles if the cancer does not progress and side effects are manageable. Participants will have regular scans to monitor the cancer.

  • Group 2: Receives 177Lu-PSMA-617 every 6 weeks for up to 6 cycles, as long as the cancer does not progress and side effects are manageable. Participants will also have regular scans.

After completing the treatment, participants will have follow-up visits every 3 months for 2 years to monitor their health and the cancer's status.

Eligibility Criteria

Inclusion Criteria

  • Must have prostate cancer confirmed by medical tests.
  • Must have at least one area where the cancer has spread, visible on scans.
  • Must have previously received chemotherapy for advanced prostate cancer.
  • Must have tried at least one hormone therapy that targets androgen receptors.
  • Must meet specific criteria based on PSMA PET scans done within 8 weeks before starting treatment.
  • Must have adequate blood cell counts and organ function as shown by specific blood tests.
  • Must be in good general health, with a performance status score between 0 and 2.
  • Must be 18 years or older.
  • Must be able to understand and sign a consent form.
  • Must be able to follow all study requirements.

Exclusion Criteria

  • Have not received 177Lu-PSMA-617 therapy before.
  • Have had certain cancer treatments within the last 6 weeks.
  • Have poor kidney function, with a filtration rate below 30 ml/min.
  • Have significant urinary tract blockage or severe kidney swelling.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.