Study on the Effectiveness of Ra-223 in Patients with Prostate Cancer Selected by PSMA PET Scans

Sponsor: University of California, San Francisco

Sponsor score: 40

ClinicalTrials ID:NCT05924672

This clinical trial is exploring how well a specific type of scan, called PSMA PET, can help choose patients with prostate cancer that has spread to the bones for treatment with Ra-223, a radiation therapy. The study aims to see if this approach can effectively target and treat cancer cells in the bones.

Patient Parameters

Program Overview

This study is investigating whether using PSMA PET scans, along with bone scans, can help select patients with prostate cancer that has spread to the bones for treatment with Ra-223. Ra-223 is a type of radiation therapy that targets cancer cells in the bones. The PSMA PET scan uses a special tracer to highlight areas where prostate cancer cells are active, helping doctors decide if Ra-223 treatment is suitable. The study will assess how well this method works in treating prostate cancer that is resistant to standard hormone therapy and has spread to the bones.

Description

The main goal of this study is to find out how many patients experience a significant drop in their PSA levels (a marker of prostate cancer) after receiving Ra-223 treatment. Researchers will also look at how long patients live after treatment, how quickly symptoms related to bone cancer appear, and the safety of Ra-223. Additionally, the study will compare how well PSMA PET scans and other imaging methods detect cancer activity.

Participants will undergo a series of scans and tests before starting Ra-223 treatment, which is given through an IV every 28 days for up to 6 cycles. After completing the treatment, participants will have follow-up visits to monitor their health and the effects of the treatment. Blood samples will be collected at various points to check for changes in cancer markers and overall health. The study will also explore how the cancer responds to subsequent treatments after Ra-223.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older.
  • Have prostate cancer that has spread to the bones and is resistant to hormone therapy.
  • Eligible for Ra-223 treatment as part of standard care.
  • Cancer must be visible on a PSMA PET scan, with no significant changes in size over the past six months.
  • Have previously tried at least one advanced hormone therapy.
  • Meet specific blood count and health criteria.
  • Able to understand and sign a consent form.
  • Willing to use birth control if they have a partner who can become pregnant.

Exclusion Criteria

  • Previous treatment with certain radioactive therapies or chemotherapy.
  • Recent use of other cancer treatments within 21 days before starting the study.
  • Cancer that involves more than 75% of the bones or has spread to other organs.
  • Recent blood transfusions.
  • Any condition that might prevent following the study procedures.

Locations

FACILITYZIPCITYSTATE
University of California, San Francisco94143San FranciscoCalifornia

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