A randomized, double‐blind, placebo‐controlled trial to evaluate the role of curcumin in prostate cancer patients with intermittent androgen deprivation. Issue 6 (22nd January 2019)

• Record Type: Journal Article
• Authors: Choi, Young Hyo; Han, Deok Hyun; Kim, Seon‐woo; Kim, Min‐Ji; Sung, Hyun Hwan; Jeon, Hwang Gyun; Jeong, Byong Chang; Seo, Seong Il; Jeon, Seong Soo; Lee, Hyun Moo; Choi, Han Yong
• Is Part Of: Prostate. Volume 79:Issue 6(2019)
• Page Start: 614
• Page End: 621
• Publication Date: 2019-01-22
• Subjects: curcumin -- intermittent androgen deprivation -- prostate cancer; Prostate -- Diseases -- Periodicals; 616
• DOI: 10.1002/pros.23766
• Languages: English
• ISSNs: 0270-4137

Abstract

Abstract : Background: The anti‐cancer activities of curcumin are well‐documented from preclinical studies using prostate cancer models. Our objective was to evaluate the anti‐cancer activity of oral curcumin in patients with prostate cancer. Methods: This randomized, double‐blind, placebo‐controlled trial was performed on patients with prostate cancer who received intermittent androgen deprivation (IAD). Participants who finished the first on‐treatment period of IAD were randomized into a curcumin or placebo group. The patients took oral curcumin (1440 mg/day) or placebo for six months and were followed up until the beginning of the second on‐treatment. The primary end‐point was duration of the first off‐treatment. The secondary end‐points were change in PSA and testosterone levels during 6 months, PSA progression rate, and health‐related quality of life (HRQOL) scores at 6 months. Safety assessments included adverse event, adverse drug reaction, and serious adverse event. Results: A total of 97 participants were randomized 1:1 to curcumin ( n = 49) and placebo ( n = 48) groups. Among them, 82 patients (84.5%) were evaluable for the analysis (39 and 43 patients in the curcumin and placebo groups, respectively). The median off‐treatment duration was 16.3 months (95% confidence interval [CI] 12.3‐20.3 months) and 18.5 months (95% CI 12.5‐23.0 months) in the curcumin and placebo groups, respectively. There was no significant difference in the curve of off‐treatment duration between the two groups ( P = 0.4816). The proportion of patients with PSA progression during the active curcumin treatment period (6 months) was significantly lower in the curcumin group than the placebo group (10.3% vs 30.2%, P = 0.0259). The change of PSA, testosterone levels during 6 months, and HRQOL scores at 6 months were not different between curcumin and placebo groups. Adverse events were higher in the placebo group (16 of 46 vs 7 of 45 patients, P = 0.0349). No significant differences in the adverse drug reaction were found between the two groups. Conclusions: Six months' intake of oral curcumin did not significantly affect the overall off‐treatment duration of IAD. However, PSA elevation was suppressed with curcumin intake during the curcumin administration period. Curcumin at this dose was well tolerated and safe.