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ACTIVE NOT RECRUITING
NCT03511196
EARLY_PHASE1

Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

Summary

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).

Official title: A Phase 1b Study of Adaptive Androgen Deprivation Therapy for State IV Castration Sensitive Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

17

Start Date

2018-09-17

Completion Date

2026-09

Last Updated

2025-12-04

Healthy Volunteers

No

Interventions

DRUG

Adaptive Androgen Deprivation Therapy (ADT)

ADT with Leuprolide, Goserelin, or Triptorelin, as GnRH agonist, every 4 weeks as outlined in study arm description.

DRUG

Abiraterone

Prednisone 5 mg once a day with food.

DRUG

Prednisone

Abiraterone 1000 mg daily with empty stomach.

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States