Study Comparing Cabazitaxel with or without Carboplatin to 177Lu-PSMA-617 in Advanced Prostate Cancer

Sponsor: Case Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06738303

Provider View

This clinical trial is exploring which treatment is more effective for patients with advanced prostate cancer that has spread and is not responding to hormone therapy and docetaxel. The study focuses on patients whose cancer cells have a specific marker called PSMA.

Patient Parameters

Program Overview

The study aims to determine the best treatment for patients with advanced prostate cancer that has spread and is not responding to hormone therapy. Initially, prostate cancer responds well to treatments that lower male hormones, but over time, it can become resistant. This type of cancer, known as metastatic castrate-resistant prostate cancer (mCRPC), has a poor outlook, with survival often less than three years. There are several treatments available, but not all patients respond well to them. This study will compare the effectiveness of two treatments: Cabazitaxel with or without Carboplatin, and 177Lu-PSMA-617, to find out which works better for patients with PSMA-positive cancer.

Description

Prostate cancer that has spread to other parts of the body and no longer responds to hormone therapy is called metastatic castrate-resistant prostate cancer (mCRPC). This type of cancer is challenging to treat, and patients often have a limited time to live. There are several treatments available, but they don't work for everyone, and it's not always clear which treatment should be tried first. This study is comparing two treatment options to see which is more effective for patients with mCRPC that is PSMA-positive. The treatments being compared are Cabazitaxel, with or without Carboplatin, and 177Lu-PSMA-617. The goal is to find out which treatment helps patients live longer and feel better.

Eligibility Criteria

Inclusion Criteria

  • Have advanced prostate cancer that has spread and is not responding to hormone therapy.
  • Have a specific marker called PSMA on cancer cells, confirmed by a scan within 12 weeks before starting the study.
  • Be 18 years or older.
  • Be in good overall health, with a performance status score between 0 and 2.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count over 1000/μL
    • Platelet count over 90,000/μL
    • Hemoglobin over 8.5 g/dL
    • Normal liver and kidney function as indicated by specific blood tests.
  • Be on a stable dose of bone-targeting therapy if applicable.
  • Agree to use effective birth control during the study and for three months after the last treatment.
  • Be able to understand and sign a consent form.
  • All races and ethnic groups are welcome to participate.

Exclusion Criteria

  • Have prostate cancer that is still sensitive to hormone therapy.
  • Have a type of prostate cancer called small cell prostate cancer.
  • Be taking any other experimental treatments.
  • Have had another significant cancer within the last two years, except for certain skin or bladder cancers.
  • Have untreated brain metastases or central nervous system disease.
  • Have allergies to the study drugs.
  • Have uncontrolled health issues, such as infections, heart problems, or mental health conditions that could interfere with the study.
  • Have unresolved side effects from previous treatments.

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