Androgen Deprivation Therapy for Advanced Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
Adaptive Androgen Deprivation Therapy (ADT) plus Standard of Care. The purpose of this study is to develop adaptive therapy for high risk metastatic castration sensitive prostate cancer (mCSPC).
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking any investigational drugs, you must stop them at least 30 days before starting the trial.
Is androgen deprivation therapy with abiraterone and prednisone safe for humans?
Abiraterone acetate, used with prednisone, is generally considered safe for treating advanced prostate cancer, but it can cause side effects like low potassium levels, high blood pressure, fluid retention, and liver issues. These side effects were relatively low in frequency in clinical trials.12345
How is the drug Abiraterone with ADT and Prednisone unique for advanced prostate cancer?
This drug combination is unique because Abiraterone, taken orally, blocks a specific enzyme (cytochrome P450 17A1) that helps produce male hormones, and when combined with Prednisone and ADT, it significantly improves survival in patients with advanced prostate cancer compared to other treatments.12678
What data supports the effectiveness of the drug Abiraterone in treating advanced prostate cancer?
Who Is on the Research Team?
Jingsong Zhang, M.D., Ph.D.
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
Are You a Good Fit for This Trial?
Men with advanced prostate cancer that responds to initial hormone therapy can join. They must be in good physical shape (ECOG 0-1), have normal organ function, and no serious health issues or surgeries in the last month. Excluded are those who've had certain treatments for prostate cancer, uncontrolled high blood pressure, severe heart problems, GI diseases affecting drug absorption, brain or liver metastases, another recent cancer diagnosis or treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in Period
Participants undergo 12-16 weeks of GnRH analog, along with 8-12 weeks of combinational therapy with GnRH analog and abiraterone plus prednisone
Treatment
Study treatment is restarted if participant's PSA reaches 2 fold or higher of his baseline PSA. Selection of treatment will be based on participant's testosterone level
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Abiraterone
- Adaptive Androgen Deprivation Therapy (ADT)
- Prednisone
Abiraterone is already approved in United States, European Union, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor