Study on Sipuleucel-T and Bipolar Androgen Therapy for Men with Advanced Prostate Cancer

Sponsor: Yale University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06100705

Provider View

This clinical trial is exploring a new treatment combination for men with advanced prostate cancer that has spread and is resistant to standard hormone therapy. The study aims to see if adding bipolar androgen therapy to Sipuleucel-T can enhance the immune response against cancer.

Patient Parameters

Program Overview

This study is testing a combination of treatments for men with metastatic castration-resistant prostate cancer (mCRPC). It involves using Sipuleucel-T, a standard treatment, along with bipolar androgen therapy (BAT). The goal is to see if this combination can improve the body's immune response to cancer. Researchers will measure the immune response and other health outcomes over 26 weeks to determine the effectiveness of this approach.

Description

Participants in this study will receive testosterone injections every four weeks. After two doses of testosterone, they will start receiving Sipuleucel-T infusions every two weeks for a total of three infusions. The testosterone injections will continue every four weeks until certain criteria for stopping treatment are met.

The study will monitor the immune response to a specific protein (PA2024) and other health markers to see if the combination of treatments is effective. Researchers will also look at how the cancer responds to the treatment, including changes in PSA levels, tumor size, and overall survival. Safety and tolerability of the treatment will also be assessed.

Participants will have regular health checks, including physical exams and PSA tests every four weeks, and imaging scans every 12 weeks to track the cancer's progress. The treatment will continue until the cancer progresses, side effects become unacceptable, or the participant decides to stop.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent before starting the study.
  • Have advanced prostate cancer that meets the criteria for Sipuleucel-T treatment.
  • Confirmed diagnosis of prostate adenocarcinoma.
  • Cancer has spread to other parts of the body, as shown by scans.
  • Prostate cancer that continues to grow despite low testosterone levels.
  • Must show signs of cancer progression, such as rising PSA levels or new cancer growth.
  • Low testosterone levels confirmed by blood tests.
  • Good overall health with a performance status of 0 or 1.
  • Adequate liver function based on specific blood tests.
  • Acceptable kidney function.
  • Healthy blood cell counts, including neutrophils, platelets, and hemoglobin.

Exclusion Criteria

  • PSA levels over 20 ng/dL in the last four weeks.
  • Previously treated with three or more specific hormone therapies.
  • Prior chemotherapy for advanced prostate cancer, unless it was for earlier stages.
  • Previous treatment with Sipuleucel-T or high-dose testosterone for prostate cancer.
  • Recent treatment with certain cancer therapies within four weeks.
  • Recent use of prednisone over 10 mg within two weeks.
  • Recent immunotherapy or specific radiotherapy within six weeks.
  • Recent palliative radiotherapy within two weeks.
  • Cancer spread to the liver.
  • Use of strong pain medications for cancer pain within four weeks.
  • Active autoimmune disease requiring high-dose steroids.
  • Active infections like HIV, Hepatitis B or C, unless resolved.
  • Recent serious infection requiring antibiotics or causing fever.
  • Life expectancy less than six months.
  • Any condition that could interfere with the study, as judged by the investigator.

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