Study on Pembrolizumab and 177Lu-PSMA-617 for Treating Advanced Prostate Cancer

Sponsor: University of California, San Francisco

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05766371

Provider View

This clinical trial is testing a new combination treatment using pembrolizumab and 177Lu-PSMA-617 for men with advanced prostate cancer that has continued to grow despite previous treatments. The study aims to see if this combination can help control the cancer and improve survival.

Patient Parameters

Program Overview

This study is exploring a new treatment for men with advanced prostate cancer that has not responded to previous therapies. The treatment combines pembrolizumab, an immunotherapy drug, with 177Lu-PSMA-617, a targeted radionuclide therapy. The main goal is to determine if this combination can help control the cancer and improve survival rates. Participants will receive up to six doses of 177Lu-PSMA-617, with pembrolizumab, and will be monitored for safety and effectiveness. Follow-up visits will occur every three months to assess health and treatment outcomes.

Description

The primary aim of this study is to find out how long patients with advanced prostate cancer can live without their cancer getting worse when treated with pembrolizumab and 177Lu-PSMA-617. Secondary goals include measuring how many patients respond to the treatment, how long these responses last, and the overall survival rate. The study will also evaluate the safety of the treatment combination.

Participants will receive up to six doses of 177Lu-PSMA-617, with at least six weeks between doses, unless the cancer progresses or side effects become too severe. Pembrolizumab will be given alongside, and treatment will continue until the cancer progresses or the doctor decides to stop based on the patient's condition. After treatment ends, participants will have follow-up visits to monitor their health and cancer status every three months until the study ends or they withdraw consent.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older with advanced prostate cancer that has continued to grow despite previous treatments.
  • Must have low testosterone levels and continue hormone therapy if they haven't had surgery to remove the testicles.
  • Have tried at least one chemotherapy treatment or are unable or unwilling to undergo chemotherapy.
  • Cancer must have progressed after using at least one second-generation hormone therapy.
  • Must have a PSMA PET scan showing cancer activity.
  • Be in good general health with a performance status score of 0 or 1.
  • Have adequate blood, liver, and kidney function based on specific medical tests.
  • Agree to use effective birth control during the study and for six months after the last treatment.
  • Willing to follow safety precautions related to radiation exposure.
  • Agree to undergo a tumor biopsy if possible.
  • If previously treated for brain metastases, must meet specific conditions such as stability and no need for steroids.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Have a specific type of prostate cancer with low PSMA expression.
  • Have certain types of cancer lesions that do not show up on PSMA PET scans.
  • Have received other cancer treatments recently or have untreated brain metastases.
  • Have had previous PSMA-targeted treatments or certain immunotherapies.
  • Are currently in another clinical trial or have recently participated in one.
  • Have had more than two lines of chemotherapy.
  • Have severe allergies to pembrolizumab or its ingredients.
  • Have active autoimmune diseases requiring treatment in the past two years.
  • Have a history of lung disease or pneumonitis.
  • Have received a live vaccine recently.
  • Have significant heart disease or recent heart events.
  • Have had major surgery recently or have active infections.
  • Have a history of HIV, active hepatitis B or C, or tuberculosis.
  • Have psychiatric or substance abuse issues that could interfere with the study.
  • Are on blood thinners that cannot be stopped for a biopsy.

Get This Program In Your Inbox

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