A Feasibility Study Evaluating a Role for Maintenance Therapy in Patients With Biochemically Progressive Castration Sensitive Prostate Cancer on Intermittent Androgen Deprivation Therapy

PHASE1RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 11, 2024

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2027

Conditions
Castration Sensitive Prostate Cancer
Interventions
DRUG

Metformin

Subjects will start with metformin 500 mg by mouth (po) two times daily (bid) with meals for 14 days. Metformin titration will then increase to 850 milligram (mg) po bid for 14 days before increasing titration to a desired dosage of 1,000 mg po bid. For those subjects currently taking Metformin, they will continue current dose (if 1,000 mg po bid) or titrate dose as just described until maximum dose is achieved.

DRUG

Turmeric

Each subject will start with 1,500 mg turmeric po daily with meals. The dose can be temporarily reduced to 1,000 mg po daily for those who report GI discomfort. If GI discomfort has resolved within one month of the dose reduction, subjects will resume 1,500 mg po daily. If GI discomfort has not resolved or resumes at increased dose, the subject may be instructed to stop taking the study treatment and removed from the study.

Trial Locations (1)

72205

RECRUITING

University of Arkansas for Medical Sciences, Little Rock

All Listed Sponsors
lead

University of Arkansas

OTHER