Study on Targeted Alpha Therapy with 225Actinium-PSMA-I&T for Advanced Prostate Cancer

Sponsor: Fusion Pharmaceuticals Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05219500

Provider View

This clinical trial is testing a new treatment called FPI-2265 for men with advanced prostate cancer that has not responded to standard hormone therapy. The study involves four doses of the treatment given over several weeks.

Patient Parameters

Program Overview

The study is exploring a new treatment for advanced prostate cancer that no longer responds to hormone therapy. The treatment, called FPI-2265, will be given in four doses over a period of weeks. Researchers aim to see if this approach can help manage the disease more effectively.

Description

This clinical trial is testing a new treatment for advanced prostate cancer that has become resistant to standard hormone therapy. The treatment involves four doses of a drug called FPI-2265, given every eight weeks. The initial dose is based on the patient's weight, and adjustments may be made if certain side effects occur or if there is a significant reduction in prostate-specific antigen (PSA) levels, which indicate cancer activity.

Participants must meet specific health criteria to join the study, including having a confirmed diagnosis of prostate cancer that has spread and is not operable, a life expectancy of at least six months, and evidence of disease progression. They must also have undergone certain previous treatments if they have specific genetic mutations. The study will monitor participants' health and response to the treatment through regular medical assessments.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Able to understand and sign a consent form.
  • Able to follow study requirements.
  • Have a confirmed diagnosis of prostate cancer.
  • Life expectancy of at least 6 months.
  • Cancer that cannot be surgically removed.
  • Evidence of disease progression based on specific medical criteria.
  • If certain genetic mutations are present, must have tried specific approved therapies.
  • Cancer must be resistant to hormone therapy, with low testosterone levels.
  • Positive PSMA PET/CT scans showing cancer spread.
  • Good overall health with specific blood counts and organ function within normal limits.
  • Must have tried at least one androgen receptor-targeted therapy.
  • Can continue anti-androgen therapy if advised by a doctor.

Exclusion Criteria

  • Recent treatment with certain cancer therapies within the last 6 weeks.
  • More than four previous lines of treatment for advanced prostate cancer.
  • Urinary tract blockage or specific bone scan results.
  • Persistent side effects from previous treatments.
  • Abnormal kidney function or blood counts.
  • Recent use of experimental drugs.
  • Cancer spread to the brain or liver.
  • Other active cancers, except for certain types of skin or bladder cancer.
  • Serious medical conditions that could affect participation.
  • Recent major surgery.
  • Planning to conceive a child during or shortly after the study.

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