Study on the Anti-Tumor Effects of (177Lu) rhPSMA-10.1 Injection for Advanced Prostate Cancer

Sponsor: Blue Earth Therapeutics Ltd

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05413850

Provider View

This clinical trial is testing a new treatment called 177Lu-rhPSMA-10.1 to see if it is safe and effective in treating 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 find out if a new treatment, 177Lu-rhPSMA-10.1, is safe and can help shrink tumors in men with advanced prostate cancer that no longer responds to hormone therapy. The study will be conducted in two parts: the first part will focus on finding the right dose and ensuring safety, while the second part will assess how well the treatment works at the selected dose. Participants must have prostate cancer that shows a specific marker called PSMA, which will be confirmed through a special scan.

Description

This study involves testing a new treatment, 177Lu-rhPSMA-10.1, for men with advanced prostate cancer that has spread and is resistant to hormone therapy. The study is divided into two phases. In Phase 1, researchers will determine the safest dose and monitor any side effects. In Phase 2, they will evaluate how effective the treatment is at shrinking tumors. Participants must have prostate cancer that expresses a marker called PSMA, confirmed by a special scan. The study will include men who have previously undergone chemotherapy and those who have not received taxane chemotherapy. Participants will need to meet specific health criteria and agree to use contraception during the study.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older with confirmed prostate cancer.
  • Low testosterone levels after surgical or chemical castration.
  • Cancer that can be seen on scans and shows PSMA markers.
  • At least 4 weeks since last cancer treatment, except for certain hormone therapies.
  • Recovery from previous treatment side effects, except for certain conditions like hair loss or mild nerve issues.
  • Major surgery must have been done at least 12 weeks before joining the study.
  • Good overall health with a life expectancy of at least 6 months.
  • Adequate blood cell counts and organ function.
  • Willingness to use effective contraception.
  • Participation in specific study groups based on previous treatments.

Exclusion Criteria

  • Allergies to the study treatment or its components.
  • Significant cancer areas that do not show PSMA markers.
  • Extensive cancer spread in the bone marrow.
  • Spinal cord issues or risk of compression.
  • History of blood cancers or brain metastases.
  • Prostate cancer with neuroendocrine features.
  • Other cancers that affect life expectancy or study results.
  • Unresolved urinary blockages.
  • Uncontrolled medical or psychiatric conditions.
  • Current use of certain bone treatments.
  • Severe urinary incontinence.
  • Single kidney or kidney transplant, or treatments that may harm kidneys.
  • Abnormal heart test results.
  • Previous extensive radiation treatments.
  • Prior treatments with specific radioactive therapies.
  • Significant metal implants that affect imaging.

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