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A Bioluminescent and Fluorescent Orthotopic Syngeneic Murine Model of Androgen-dependent and Castration-resistant Prostate Cancer
Published on: March 6, 2018
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Muscadine Grape Skin Extract in Biochemically Recurrent Prostate Cancer: A Randomized, Placebo-Controlled,
A Mandl1, M L Zahurak1, N A Metri1
1Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins, Baltimore, MD, USA.
The Prostate
|May 6, 2025
Summary
Muscadine grape skin extract (MPX) did not significantly alter PSA slope in men with biochemically recurrent prostate cancer (BCRPC) and the SOD2 Ala/Ala variant. This trial underscores the need for rigorous studies in integrative oncology.
Area of Science:
- Integrative Oncology
- Prostate Cancer Research
- Clinical Trial Design
Background:
- Biochemically recurrent prostate cancer (BCRPC) patients often delay androgen deprivation therapy (ADT) due to side effects.
- Muscadine grape skin extract (MPX) showed promise in a prior Phase II trial subgroup, increasing PSA doubling time (PSADT) in patients with the SOD2 Ala/Ala variant.
- This rationale led to a larger, randomized trial evaluating MPX in this specific patient population.
Purpose of the Study:
- To evaluate the efficacy of MPX compared to placebo in patients with BCRPC and the SOD2 Ala/Ala genotype.
- To determine the effect of MPX on PSA slope, PSADT, PSA response, and PSA progression-free survival (PFS).
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 59 patients with BCRPC and SOD2 Ala/Ala genotype across 14 sites.
- Patients received either 4000 mg of MPX or a placebo daily.
- Primary endpoint was on-study PSA slope; secondary endpoints included PSADT, PSA response, and PSA PFS. Correlative studies assessed oxidative stress and gut microbiota.
Main Results:
- The study was stopped early due to futility, as no significant differences in PSA slope were observed between the MPX and placebo groups at any time point (p=0.49).
- Secondary endpoints, including PSADT, PSA response, and PSA PFS, also showed no significant differences.
- MPX was well-tolerated, with no drug-related severe adverse events. Microbiome analysis indicated an increased abundance of specific bacteria (Roseburia faecis, Akkermansia muciniphila) in the MPX group.
Conclusions:
- MPX supplementation did not demonstrate a significant effect on PSA slope in men with BCRPC and the SOD2 Ala/Ala variant.
- The study provides a robust evaluation of a natural product in a targeted patient group.
- This research emphasizes the critical role of well-designed clinical trials in advancing evidence-based integrative oncology.
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