Muscadine Grape Skin Extract in Biochemically Recurrent Prostate Cancer: A Randomized, Placebo‐Controlled, Biomarker‐Enriched Trial in Patients With the SOD2 Ala/Ala Variant DOI
Adel Mandl, Marianna Zahurak, Najwa‐Joelle Metri

et al.

The Prostate, Journal Year: 2025, Volume and Issue: unknown

Published: May 5, 2025

Background Many patients with biochemically recurrent prostate cancer (BCRPC) prefer to delay androgen deprivation therapy (ADT) due its adverse effects, highlighting the need for better‐tolerated, effective alternatives. A subgroup analysis of our prior Phase II trial showed that muscadine grape skin extract (MPX) increased PSA doubling time (PSADT) in SOD2 Ala/Ala variant which provided rationale this trial. Methods This randomized, double‐blind, placebo‐controlled trial, conducted at 14 sites, evaluated BCRPC and genotype. Patients received 4000 mg MPX or placebo daily. The primary endpoint was on‐study slope comparisons between treatment arms. Secondary endpoints were PSADT, response (≥ 50% decrease), progression free survival (PFS). Correlative studies included markers oxidative stress gastrointestinal microbiota composition. Results At interim analysis, fifty‐nine randomized (MPX, n = 29; placebo, 30). On‐study slopes 12, 24, 36, 48 weeks no significant differences arms ( p 0.49). study stopped futility. No observed response, median PFS, biomarkers. well‐tolerated, grade 3–4 AEs attributable drug. Microbiome alpha diversity but revealed relative abundance Roseburia faecis Akkermansia muciniphila group. Conclusions Although supplementation had effect on men variant, provides a rigorous evaluation natural product highlights importance well‐designed clinical trials advancing evidence‐based integrative oncology. Trial registration ClinicalTrials. gov, NCT03535675.

Language: Английский

Muscadine Grape Skin Extract in Biochemically Recurrent Prostate Cancer: A Randomized, Placebo‐Controlled, Biomarker‐Enriched Trial in Patients With the SOD2 Ala/Ala Variant DOI
Adel Mandl, Marianna Zahurak, Najwa‐Joelle Metri

et al.

The Prostate, Journal Year: 2025, Volume and Issue: unknown

Published: May 5, 2025

Background Many patients with biochemically recurrent prostate cancer (BCRPC) prefer to delay androgen deprivation therapy (ADT) due its adverse effects, highlighting the need for better‐tolerated, effective alternatives. A subgroup analysis of our prior Phase II trial showed that muscadine grape skin extract (MPX) increased PSA doubling time (PSADT) in SOD2 Ala/Ala variant which provided rationale this trial. Methods This randomized, double‐blind, placebo‐controlled trial, conducted at 14 sites, evaluated BCRPC and genotype. Patients received 4000 mg MPX or placebo daily. The primary endpoint was on‐study slope comparisons between treatment arms. Secondary endpoints were PSADT, response (≥ 50% decrease), progression free survival (PFS). Correlative studies included markers oxidative stress gastrointestinal microbiota composition. Results At interim analysis, fifty‐nine randomized (MPX, n = 29; placebo, 30). On‐study slopes 12, 24, 36, 48 weeks no significant differences arms ( p 0.49). study stopped futility. No observed response, median PFS, biomarkers. well‐tolerated, grade 3–4 AEs attributable drug. Microbiome alpha diversity but revealed relative abundance Roseburia faecis Akkermansia muciniphila group. Conclusions Although supplementation had effect on men variant, provides a rigorous evaluation natural product highlights importance well‐designed clinical trials advancing evidence‐based integrative oncology. Trial registration ClinicalTrials. gov, NCT03535675.

Language: Английский

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