Study on Targeted Radiation Without Hormone Therapy for Advanced Prostate Cancer

Sponsor: VA Office of Research and Development

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06084338

Provider View

This clinical trial is exploring a new treatment approach for men with advanced prostate cancer that no longer responds to hormone therapy. The study tests if combining targeted radiation and a specific drug therapy, while stopping hormone therapy, can effectively treat the cancer. Some participants will also receive testosterone replacement therapy.

Patient Parameters

Program Overview

The trial aims to find out if a combination of precise radiation therapy, a drug targeting PSMA, and stopping hormone therapy can effectively treat metastatic castration-resistant prostate cancer. All participants will receive radiation and the PSMA-targeted drug, and half will be randomly chosen to also receive testosterone replacement therapy.

Description

This study is testing a new treatment for men with advanced prostate cancer that has spread and is resistant to hormone therapy. The treatment involves using a precise form of radiation therapy called stereotactic body radiation therapy (SBRT) to target all cancer sites, along with a drug that targets PSMA, a protein found on prostate cancer cells. Participants will stop hormone therapy, and some will also receive testosterone replacement therapy. The study is designed to see if this approach can effectively control the cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must provide written consent to participate.
  • Diagnosed with prostate cancer of a specific type (adenocarcinoma).
  • Cancer has spread to bones or soft tissues, confirmed by scans.
  • Cancer shows PSMA activity on specific scans.
  • Cancer is resistant to hormone therapy, with low testosterone levels and signs of progression.
  • Previously used certain hormone therapy drugs.
  • Good overall health with an ECOG score of 0-2.
  • Up to 10 cancer sites detectable on scans and treatable with radiation.
  • Life expectancy of at least 6 months.
  • Adequate organ function based on blood tests.
  • Agree to use contraception during and after the study.

Exclusion Criteria

  • Cancer has spread to the liver or brain.
  • Certain types of prostate cancer (small cell/neuroendocrine carcinoma).
  • Recent cancer treatments must be completed before starting the study.
  • Cannot use certain herbal products that affect PSA levels.
  • Recent radiotherapy must be completed before starting the study.
  • Recent major surgery must be recovered from before starting the study.
  • History of other active cancers requiring treatment in the past 2 years.
  • Active infections or conditions needing antibiotics.
  • Local cancer recurrence after previous treatment.
  • Conditions that might interfere with the study or participant's health.
  • Planning to have children during or shortly after the study.
  • Urgent need for radiation therapy for spinal cord compression or other conditions.

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