NCT02415621

Adaptive Abiraterone Therapy for Metastatic Castration Resistant Prostate Cancer

A Pilot Study of Adaptive Abiraterone Therapy for Metastatic Castration Resistant Prostate Cancer

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In this pilot study, 10 black participants and 15 non-black participants will be enrolled after achieving 50% or more decline of their prostatic specific antigen (PSA) while on abiraterone for asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer (mCRPC). Abiraterone will be stopped and will not be re-initiated until there is 50% or more increase of the PSA. Each time abiraterone is stopped, it will be defined as the start of a new adaptive therapy cycle. Participants who cannot achieve a 50% decline of their PSA after restarting abiraterone will continue abiraterone until they develop radiographic disease progression. If the decline in performance status does not occur at the time of radiographic disease progression, participants will be followed until they develop radiographic disease progression. The study will be terminated early if less than 3 of the first 10 enrolled participants can complete 2 cycles of the adaptive abiraterone.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Abiraterone Acetate	1000 mg by mouth (PO) every day (QD)

Timeline

• Start date: 2015-04-13
• Primary completion: 2019-08-12
• Completion: 2026-07-01
• First posted: 2015-04-14
• Last updated: 2025-12-04

Locations

1 site across 1 country: United States