Abiraterone Therapy for Metastatic Castration Resistant Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
Abiraterone is approved in the United States by the U.S. Food and Drug Administration (FDA) to treat metastatic prostate cancer at 1000 mg daily.The purpose of this study is to find out if an on and off schedule of taking abiraterone would prolong the participant's cancer's response to this drug and maintain their functionality to perform their daily activities.
Will I have to stop taking my current medications?
You may need to stop certain medications. The trial requires stopping any prostate cancer therapies, except for GnRH analogue therapy, at least 3 weeks before starting the study drugs. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
Is abiraterone acetate safe for humans?
What makes the drug abiraterone acetate unique for treating metastatic castration-resistant prostate cancer?
Abiraterone acetate (Zytiga) is unique because it is an oral medication that selectively inhibits the cytochrome P450 17A1 enzyme, which is crucial for testosterone production, and is used in combination with prednisone to improve survival in patients with metastatic castration-resistant prostate cancer who have previously received chemotherapy.12346
What data supports the effectiveness of the drug Abiraterone Acetate (Zytiga) for metastatic castration-resistant prostate cancer?
In clinical trials, Abiraterone Acetate (Zytiga) combined with prednisone significantly improved overall survival and delayed disease progression in patients with metastatic castration-resistant prostate cancer compared to a placebo with prednisone. This drug is considered an important first-line option for this condition due to its effectiveness and manageable safety profile.12467
Who Is on the Research Team?
Jingsong Zhang, MD
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
Are You a Good Fit for This Trial?
This trial is for men with metastatic castration-resistant prostate cancer who are minimally symptomatic and have seen a significant drop in PSA levels after standard abiraterone treatment. They should be able to perform daily activities, not require opioids for pain, and have no major health issues or recent surgeries.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive adaptive abiraterone therapy, with cycles defined by PSA response
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Abiraterone Acetate
Abiraterone Acetate 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