Study on Bortezomib for Treating Advanced Prostate Cancer with PTEN Deletion

Sponsor: University of Utah

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06029998

This clinical trial is testing the effectiveness of bortezomib in reducing PSA levels in men with advanced prostate cancer that has spread and is resistant to hormone therapy, specifically in those with a PTEN gene deletion.

Patient Parameters

Program Overview

The purpose of this study is to evaluate if bortezomib can help lower PSA levels in men with metastatic castration-resistant prostate cancer (mCRPC) who have a PTEN gene deletion. Participants will receive bortezomib through a subcutaneous injection for up to 8 cycles, with each cycle lasting about 21 days.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 years or older.
  • Diagnosed with prostate cancer confirmed by lab tests, without small cell features.
  • Have had surgery to remove the testicles or are on ongoing hormone therapy, with low testosterone levels.
  • Previously treated with at least one advanced hormone therapy, such as abiraterone or enzalutamide.
  • No prior systemic treatment for mCRPC, except for certain hormone therapies.
  • Available tumor tissue sample or able to provide a new biopsy.
  • Have a PTEN gene deletion confirmed by genetic testing.
  • Cancer must be progressing according to the study doctor.
  • General health status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Adequate organ function based on specific blood tests.
  • Agree to use effective contraception during the study and for 4 months after the last dose.
  • Recovery from any previous treatment side effects to a mild level.
  • Able to understand and sign a consent form.
  • Life expectancy of more than 3 months.

Exclusion Criteria

  • Have nerve damage of grade 2 or higher.
  • Currently receiving other experimental treatments.
  • Have had other cancer treatments or experimental drugs within 14 days before starting the study.
  • Have had major surgery within 14 days before starting the study and not fully recovered.
  • Diagnosed with another cancer within the last 2 years, except for certain skin or localized cancers.
  • Have known brain metastases or disease affecting the brain lining, unless treated and stable for at least 4 weeks.
  • Have uncontrolled or significant health issues, such as severe heart problems or recent stroke.
  • Have a known HIV infection with a detectable viral load, unless on effective treatment.
  • Have active infections like tuberculosis or hepatitis B or C, unless resolved or controlled.
  • Have severe allergies to the study drug or its components.
  • Taking medications that are not allowed during the study, unless stopped for a sufficient time before starting treatment.

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