Study on 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identifying and Treating PSMA-Expressing Metastatic Castrate Resistant Prostate Cancer

Sponsor: Clarity Pharmaceuticals Ltd

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04868604

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment, 67Cu-SAR-bisPSMA, for men with advanced prostate cancer that has spread and is resistant to standard hormone therapy.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how safe and effective the new treatment 67Cu-SAR-bisPSMA is for men with advanced prostate cancer that has spread to other parts of the body and is not responding to hormone therapy. The study will involve participants who have prostate cancer that shows a specific marker called PSMA, which can be detected using a special scan.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and have signed a consent form.
  • Have a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Expected to live more than 6 months.
  • Confirmed diagnosis of prostate cancer.
  • Positive result on a special PET/CT scan showing PSMA marker in cancer lesions.
  • Low testosterone levels due to previous hormone therapy.
  • Prostate cancer that has progressed despite previous treatments like enzalutamide or abiraterone.
  • At least one metastatic lesion visible on recent imaging scans.
  • Recovered from side effects of previous treatments to a manageable level.
  • Adequate organ function, including specific blood cell counts and liver and kidney function.
  • If HIV positive, must be healthy with a low risk of AIDS-related outcomes.
  • Must use effective birth control if there is a risk of pregnancy.

Exclusion Criteria

  • Major surgery within the last 12 weeks.
  • Cancer spread to the brain.
  • Diagnosis of small cell or neuroendocrine prostate cancer.
  • History of leukemia or Myelodysplastic Syndrome.
  • Recent blood clots in veins or lungs.
  • Severe urinary tract blockage.
  • Cancer lesions that do not show the PSMA marker on the scan.
  • Previous treatment with certain radioactive drugs within the last 6 months.
  • Recent treatment with other cancer therapies, except for certain hormone therapies.
  • Recent participation in another clinical trial.
  • Allergic reaction to the study drugs.
  • Blood transfusion just to qualify for the study.
  • Spinal metastasis causing or threatening spinal cord compression.
  • Serious medical conditions that could interfere with the study.
  • Other cancers that could affect life expectancy or study results, unless treated and disease-free for over 3 years.
  • Any condition that poses a radiation safety risk.
  • Scheduled for external beam radiation therapy after joining the study.

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