Study on 64Cu-SAR-BBN and 67Cu-SAR-BBN for Identifying and Treating a Specific Type of Prostate Cancer

Sponsor: Clarity Pharmaceuticals Ltd

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05633160

Provider View

This clinical trial is exploring a new treatment for patients with a type of prostate cancer that has spread and is resistant to standard hormone therapy. The study focuses on patients who cannot receive a different treatment called 177Lu-PSMA-617.

Patient Parameters

Program Overview

The purpose of this study is to test the safety and effectiveness of a new treatment, 67Cu-SAR-BBN, in patients with a specific type of prostate cancer that has spread and is resistant to standard hormone therapy. This study is for patients who cannot receive another treatment called 177Lu-PSMA-617.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of prostate cancer.
  • Must have at least one cancerous area that can be seen on a scan.
  • Must have a positive result on a specific PET/CT scan.
  • Must have low testosterone levels due to previous treatments.
  • Must have prostate cancer that is progressing despite previous treatments.
  • Must not be eligible for 177Lu-PSMA therapy due to specific reasons.
  • Must have recovered from any significant side effects of previous treatments.
  • Must have adequate organ function, including:
    • Sufficient white blood cells, neutrophils, and platelets.
    • Hemoglobin level of at least 9 g/dL.
    • Normal liver and kidney function.
  • If HIV positive, must be healthy and at low risk for complications.
  • If sexually active with a partner who can become pregnant, must use effective birth control.

Exclusion Criteria

  • Recent major surgery within the last 12 weeks.
  • Cancer that has spread to the brain and is causing symptoms.
  • A type of prostate cancer called small cell prostate cancer.
  • History of certain blood disorders like leukemia.
  • Recent blood clots in veins or lungs.
  • Severe urinary tract blockage.
  • Cancer areas that do not show up on a specific PET/CT scan.
  • Previous treatment with certain radioactive drugs within specific time frames.
  • Recent treatment with other cancer therapies or investigational drugs.
  • Allergies to the study drugs or similar medications.
  • Need for blood transfusions to qualify for the study.
  • Cancer spread to the spine causing symptoms or risk of 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.
  • Conditions that pose a radiation safety risk.
  • Scheduled for external radiation therapy after joining the study.
  • Heart rhythm issues with QTc over 470 milliseconds.
  • Ongoing pancreatitis.

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