Introduction: Researchers have found that allopurinol, a xanthine oxidase inhibitor, may be beneficial in treating cancer preclinically. Specifically, this phase II clinical trial aims to investigate how allopurinol modulates relevant biomarkers of prostate cancer progression.
Methods: A meticulously designed randomized, double-blind, placebo-controlled trial was conducted with 80 patients diagnosed with localized prostate cancer. Participants were randomly assigned to receive allopurinol (300 mg/day) or a placebo for 6 months. The primary endpoints, changes in prostate-specific antigen (PSA) levels and tumor volume assessed by MRI, were rigorously measured. Secondary endpoints, changes in oxidative stress markers and inflammatory cytokines, were also carefully monitored. Blood samples were collected at baseline, 3 months, and 6 months for biomarker analysis. Statistical analysis involved paired t-tests and ANOVA for within-group and between-group comparisons, respectively, to ensure robust findings.
Results: Of the 80 participants, 72 completed the study (allopurinol group, n=36; placebo group, n=36). The allopurinol group exhibited a significant reduction in PSA levels (mean decrease 2.4 ± 1.1 ng/mL) compared to the placebo group (mean decrease 0.8 ± 0.6 ng/mL, p < 0.01). Tumor volume reduction was also significant in the allopurinol group (mean reduction 15.3 ± 3.7%) versus the placebo group (mean reduction 6.5 ± 2.8%, p < 0.01). Oxidative stress markers, such as malondialdehyde, decreased significantly in the allopurinol group (mean decrease 1.8 ± 0.4 µmol/L) compared to placebo (mean decrease 0.5 ± 0.2 µmol/L, p < 0.001). Inflammatory cytokines, including IL-6, showed significant reductions in the allopurinol group (mean decrease 1.5 ± 0.3 pg/mL) versus placebo (mean decrease 0.4 ± 0.1 pg/mL, p < 0.01).
Conclusion: Allopurinol's significant efficacy in reducing PSA levels, tumor volume, oxidative stress, and inflammatory markers in prostate cancer patients is a promising development. These findings suggest a potential shift in the prostate cancer management landscape, offering new hope and possibilities for improved patient outcomes. Allopurinol could emerge as a valuable adjunct therapy, enhancing the current arsenal of prostate cancer treatments.
Keywords: Allopurinol, Prostate Cancer, Phase II Trial, Biomarkers, Tumor Progression