This Phase I/II open-label trial aims to evaluate the safety and efficacy of the herbal supplement INM176 in patients with a history of prostate cancer or low-risk disease under active surveillance. The study will determine the recommended Phase II dose (RP2D) and assess the efficacy of INM176 in stabilizing or decreasing plasma PSA levels in post-radical prostatectomy (RP) and post-radiation therapy (RT) patients with rising PSA levels.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Safety of INM176 after 1, 2, 3,4, 5, and 6 cycles of exposure at RP2D
Timeframe: 10 months
Efficacy of INM176 by Measuring PSA Level Changes After 6 Cycles of Treatment at the Recommended Phase II Dose (RP2D)
Timeframe: 10 months
Maximum Tolerated Dose (MTD)
Timeframe: 28 days
Recommended Phase II Dose (RP2D)
Timeframe: 28 days
Dose-Limiting Toxicities (DLTs)
Timeframe: 28 days