Abiraterone Therapy for Metastatic Castration Resistant Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Jingsong Zhang, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

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.

Eligibility Criteria

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

Ability to give written informed consent

My prostate cancer is advanced but not causing major symptoms, and my PSA levels have dropped by at least 50% since starting abiraterone.

My prostate cancer diagnosis was confirmed through a tissue sample.

Exclusion Criteria

Inability to comply with protocol requirements

Treatment with any investigational compound within 30 days prior to the first dose of study drugs

My cancer has spread to my brain or liver.

Participant Groups

The study tests if taking abiraterone on an intermittent schedule can extend the drug's effectiveness in controlling prostate cancer while maintaining patients' ability to carry out everyday tasks.

Group I: Abiraterone Acetate Therapy Experimental Treatment 1 Intervention

Study schedule involves stopping FDA Approved abiraterone after participants achieve a good PSA response (50% or more decline of pre-abiraterone PSA) and then restarting abiraterone after their PSA reaches the level of pre-abiraterone PSA.

Abiraterone Acetate is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Zytiga for:

• Metastatic castration-resistant prostate cancer
• Metastatic high-risk castration-sensitive prostate cancer

🇪🇺 Approved in European Union as Zytiga for:

• Metastatic castration-resistant prostate cancer
• Newly diagnosed high-risk metastatic hormone-sensitive prostate cancer

🇨🇦 Approved in Canada as Zytiga for:

• Metastatic castration-resistant prostate cancer
• Metastatic castration-sensitive prostate cancer

🇯🇵 Approved in Japan as Zytiga for:

• Prostate cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

H. Lee Moffitt Cancer Center and Research Institute Tampa, FL

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute Lead Sponsor

References