Daniel M Moreira1, David G Bostwick2, Gerald L Andriole3, Bercedis L Peterson4, Harvey J Cohen5, Ramiro Castro-Santamaria6, Stephen J Freedland7. 1. Department of Urology, Mayo Clinic, Rochester, Minnesota. Electronic address: moreira.daniel@mayo.edu. 2. Bostwick Laboratories, Inc., Glen Allen, Virginia. 3. Division of Urologic Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, Missouri. 4. Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina. 5. Department of Medicine, Duke University School of Medicine, Durham, North Carolina. 6. GlaxoSmithKline, Inc., Global R & D Unit, King of Prussia, Pennsylvania. 7. Urology Section, Veterans Affairs Medical Center, Durham, North Carolina; Division of Urology, Department of Surgery, Cedars Sinai Medical Center, Los Angeles, California.
Abstract
PURPOSE: We evaluated whether the presence and severity of baseline prostate atrophy in men with initial biopsy negative for prostate cancer was associated the risk of subsequent prostate cancer detection in a clinical trial with scheduled study mandated biopsies. MATERIALS AND METHODS: We retrospectively analyzed the records of 3,084 men 50 to 75 years old with prostate specific antigen between 2.5 and 10 ng/ml, and a prior negative biopsy in the placebo arm of the REDUCE (Reduction by Dutasteride of Prostate Cancer Events) study who completed at least 1 per-protocol biopsy. Prostate cancer (defined as present or absent) and prostate atrophy (graded as absent, mild or moderate/marked) was assessed by central pathology review. The association of baseline atrophy with positive 2 and 4-year repeat biopsies was evaluated with logistic regression, controlling for baseline covariates. RESULTS:Baseline prostate atrophy was detected in 2,143 men (70%) and graded as mild and moderate/marked in 1,843 (60%) and 300 (10%) baseline biopsies, respectively. Patients with atrophy were older and had a larger prostate, and more acute and chronic prostate inflammation. At 2-year biopsy the prostate cancer incidence was 17% (508 cases). Baseline atrophy was significantly associated with lower prostate cancer risk (univariable and multivariable OR 0.60, 95% CI 0.50-0.74 and OR 0.67, 95% CI 0.54-0.83, p <0.001, respectively) at the 2-year biopsy. These results were similar at the 4-year biopsy (univariable and multivariable OR 0.70, 95% CI 0.53-0.93 and OR 0.72, 95% CI 0.53-0.97, p = 0.03, respectively). Relative to no atrophy the prostate cancer risk at the 2-year repeat biopsy was lower for mild atrophy (OR 0.69, 95% CI 0.55-0.86) and moderate/marked atrophy (OR 0.51, 95% CI 0.34-0.76, each p <0.001). CONCLUSIONS:Baseline prostate atrophy in men with a prostate biopsy negative for prostate cancer was independently associated with subsequent lower prostate cancer detection.
RCT Entities:
PURPOSE: We evaluated whether the presence and severity of baseline prostate atrophy in men with initial biopsy negative for prostate cancer was associated the risk of subsequent prostate cancer detection in a clinical trial with scheduled study mandated biopsies. MATERIALS AND METHODS: We retrospectively analyzed the records of 3,084 men 50 to 75 years old with prostate specific antigen between 2.5 and 10 ng/ml, and a prior negative biopsy in the placebo arm of the REDUCE (Reduction by Dutasteride of Prostate Cancer Events) study who completed at least 1 per-protocol biopsy. Prostate cancer (defined as present or absent) and prostate atrophy (graded as absent, mild or moderate/marked) was assessed by central pathology review. The association of baseline atrophy with positive 2 and 4-year repeat biopsies was evaluated with logistic regression, controlling for baseline covariates. RESULTS: Baseline prostate atrophy was detected in 2,143 men (70%) and graded as mild and moderate/marked in 1,843 (60%) and 300 (10%) baseline biopsies, respectively. Patients with atrophy were older and had a larger prostate, and more acute and chronic prostate inflammation. At 2-year biopsy the prostate cancer incidence was 17% (508 cases). Baseline atrophy was significantly associated with lower prostate cancer risk (univariable and multivariable OR 0.60, 95% CI 0.50-0.74 and OR 0.67, 95% CI 0.54-0.83, p <0.001, respectively) at the 2-year biopsy. These results were similar at the 4-year biopsy (univariable and multivariable OR 0.70, 95% CI 0.53-0.93 and OR 0.72, 95% CI 0.53-0.97, p = 0.03, respectively). Relative to no atrophy the prostate cancer risk at the 2-year repeat biopsy was lower for mild atrophy (OR 0.69, 95% CI 0.55-0.86) and moderate/marked atrophy (OR 0.51, 95% CI 0.34-0.76, each p <0.001). CONCLUSIONS: Baseline prostate atrophy in men with a prostate biopsy negative for prostate cancer was independently associated with subsequent lower prostate cancer detection.
Authors: Yiwen Zhang; Cindy Ke Zhou; Michelangelo Fiorentino; Ericka M Ebot; Emily M Rencsok; Katja Fall; Tamara L Lotan; Massimo Loda; Francesca Giunchi; Elizabeth A Platz; Angelo M De Marzo; Lorelei A Mucci Journal: Cancer Epidemiol Biomarkers Prev Date: 2019-09-18 Impact factor: 4.254
Authors: D M Moreira; D M de O Freitas; J C Nickel; G L Andriole; R Castro-Santamaria; S J Freedland Journal: Prostate Cancer Prostatic Dis Date: 2017-06-06 Impact factor: 5.554