PRIMARY OBJECTIVE:
I. To determine the effect of a 3-to-6-week intervention of urolithin A (Uro-A)
supplements versus placebo on 8-OHdG percent positive change in prostate cancer tumor
tissue obtained by core needle biopsy in participants who undergo radical prostatectomy
after 3 to 6 weeks of therapy.
SECONDARY OBJECTIVES:
I. To determine prostate tissue and plasma concentrations of Uro-A, urolithin sulfate and
urolithin A glucuronide, as measured by change from baseline to end-of-study, in
comparison to changes from baseline to end-of-study in a control group receiving a
placebo (except tissue levels, which will be compared between arms using end-of-study
tissue only).
II. To compare the change in expression of cell cycle genes in prostate cancer tumor
tissue from pre-study biopsy to radical prostatectomy in men receiving Uro-A supplements
for 3 to 6 weeks and a control group of men receiving a placebo.
III. To determine the effect of Uro-A supplements on change in 8-OHdG expression in
benign and tumor-adjacent prostatic tissue from pre-study biopsy to radical prostatectomy
(RP) following 3-6 weeks of therapy in comparison to a control group of men receiving a
placebo.
EXPLORATORY OBJECTIVES:
I. To determine the effect of Uro-A supplements on circulating levels of high sensitivity
C-reactive protein (hsCRP), TNF-alpha, and IL-6, as measured by change from baseline to
end-of-study compared with the men receiving a placebo.
II. To compare change in tumor gene expression patterns of Hallmark androgen signaling
between study arms.
III. To determine the effect of a 3-to-6-week intervention of urolithin A (Uro-A)
supplements versus placebo on 8-OHdG H-index (percent staining positive at each score in
a 0-3 scale) change in prostate cancer tumor tissue obtained by core needle biopsy at
baseline and at radical prostatectomy after 3 to 6 weeks of therapy.
IV. To collect stool samples for future analyses to determine the effect of Uro-A
supplements on change in stool microbiome 16s ribosomal ribonucleic acid (rRNA) gene
sequencing.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive urolithin A orally (PO) twice daily (BID) for 3-6 weeks prior to
standard of care (SOC) RP. Patients also undergo biopsy at time of surgery and collection
of blood samples during screening and on study.
ARM II: Patients receive placebo orally (PO) twice daily (BID) for 3-6 weeks prior to SOC
RP. Patients also undergo biopsy at time of surgery and collection of blood samples
during screening and on study.
Patients are followed up at 2 weeks after surgery.
