Study on Carboplatin, Cabazitaxel, and Abiraterone for Treating Metastatic Castration Sensitive Prostate Cancer
Sponsor: Masonic Cancer Center, University of Minnesota
ClinicalTrials ID:NCT03934840
This phase II clinical trial is testing a combination of chemotherapy and hormone therapy to see if it can effectively treat metastatic castration sensitive prostate cancer. The study will assess how well the treatment works and its safety.
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Program Overview
This study is exploring a treatment for metastatic castration sensitive prostate cancer using a combination of chemotherapy drugs (carboplatin and cabazitaxel) and hormone therapy (ADT and abiraterone). Patients will receive six cycles of chemotherapy with carboplatin and cabazitaxel, alongside ADT. After completing chemotherapy, they will continue with abiraterone and ADT. The main goal is to see how many patients have no progression of their cancer after one year. The study will also look at how long patients remain free from cancer progression and how quickly their PSA levels drop and rise again.
Eligibility Criteria
Inclusion Criteria
- Able to provide written consent to participate in the study.
- Diagnosed with prostate cancer that has spread to other parts of the body.
- Have a high volume of metastatic disease, such as cancer in organs or multiple bone lesions.
- Have been on hormone therapy (ADT) for 3 months or less.
- Low testosterone levels (below 50 ng/dL) and continuing hormone therapy if not surgically castrated.
- In good general health with an ECOG performance status of 0 or 1.
- Have adequate blood cell counts and organ function based on specific lab tests.
- Men must use condoms during intercourse while on the study drugs and for 30 days after stopping treatment to prevent drug exposure to partners.
- Must be 18 years or older.
Exclusion Criteria
- Have previously received chemotherapy, PARP inhibitors, or immunotherapy for prostate cancer.
- Have taken abiraterone or enzalutamide for more than 2 weeks.
- Have had recent radiation therapy or major surgery.
- Have used other prostate cancer treatments recently, except for certain anti-androgens.
- Have a PSA level below 2.0 ng/mL at diagnosis.
- Have significant nerve damage (peripheral neuropathy) above a certain level.
- Have another active cancer that could interfere with the study.
- Have cancer that has spread to the brain unless stable and treated.
- Have severe psychiatric conditions or social issues that could affect participation.
- Have a history of not following medical advice or unable to consent.
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