Muscadine Plus (MPX) In Men With Prostate Cancer

Phase 3 Terminated 59 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Greater Washington Community Foundation · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This research is being done to determine if men with rising PSA after initial therapy for localized prostate cancer who display the Alanine/Alanine SOD2 genotype of MnSOD and supplement their diet with MPX have greater decrease in PSA slope following treatment compared to men that do not supplement with MPX.

Timeline

Start: 2018-10-30
Primary completion: 2022-07-06
Completion: 2022-11-03

Outcome

Missed primary endpoint

Stopped: “The study was terminated by DSMB due to futility.”

paper On-study PSA slopes at 12, 24, 36, and 48 weeks showed no significant differences between the MPX and placebo arms (p = 0.49). PMID 40325900 ↗

Publications

Mandl A, Zahurak ML, Metri NA, Shore ND, Mao S, McKay RR, Taplin ME, Szmulewitz RZ, Maughan BL, Reichert ZR, Kessler ER, Heath EI, Dreicer R, Stein CA, Milne GL, Sfanos KS, Ernst SE, Mummert LA, Cruz-Lebron A, Michel SLJ, Kane MA, Hursey M, Worth MA, Wagner WD, Eshleman JR, Debeljak M, Xu L, Cao H, Dowling D, Marshall CH, Markowski MC, Denmeade SR, Eisenberger MA, Antonarakis ES, Carducci MA, Paller CJ. Muscadine Grape Skin Extract in Biochemically Recurrent Prostate Cancer: A Randomized, Placebo-Controlled, Biomarker-Enriched Trial in Patients With the SOD2 Ala/Ala Variant. Prostate. 2025 Jul;85(10):966-976. doi: 10.1002/pros.24903. Epub 2025 May 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Muscadine Plus	Unknown	4000 mg	Oral