The Risks and Benefits of 5α-Reductase Inhibitors for Prostate-Cancer Prevention

Theoret, Marc R.; Ning, Yang‐Min; Zhang, Jenny J.; Justice, Robert; Keegan, Patricia; Pazdur, Richard

doi:10.1056/nejmp1106783

Cited by 151 publications

(111 citation statements)

References 5 publications

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“…Due to our relatively small sample size we were not able to assess the impact of most prevalent tumor patterns on patient survival. There is a growing concern that use of finasteride can increase the number of patients diagnosed with high-grade tumor (Gleason score > 8) (Kramer et al, 2009, Theoret et al, 2011, Thompson et al, 2013. Food and Drug Administration (FDA) issued a change in safety information of the medication, adding the mentioned warning (Thompson et al, 2013).…”

Section: Discussionmentioning

confidence: 99%

Survival of Patients with Prostate Cancer in Yazd, Iran

Zahir

Nazemian²,

Zand³

et al. 2014

Asian Pacific Journal of Cancer Prevention

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Background: Prostate cancer is the second leading cause of cancer death in men worldwide. Several factors such as availability of screening tests, and dietary, other lifestyle, environmental and genetic influences contribute to worldwide disparities in prostate cancer incidence and mortality rates. Our aims were to investigate patient characteristics at the time of diagnosis, common treatment strategies employed and survival in an Iranian male population with prostate cancer. Materials and Methods: Archives of Pathology Departments of five referral centers affiliated with the School of Medicine of Shahid Sadoughi University in Yazd province were reviewed. Paraffin-embedded blocks were reviewed by two independent pathologists to confirm the diagnosis. The latest modification of the Gleason Scoring System was adopted to determine pathological grading. Following pathological evaluation, patients were contacted via telephone to acquire information regarding their current status. Results: Pathology blocks were available for 113 patients. However, upon phone contacts, we were unable to determine the survival status in 23 patients (response rate=83%). Therefore, 90 patients were enrolled in the final analysis. The median follow-up time was 6.0 years (ranging from 0.3 to 8.8 years). There were 30 death attributed to prostate cancer in the study group. Kaplan-Meier analysis revealed that patient age at the time of diagnosis was a significant predictor of survival. Another significant predictor of poorer survival was higher tumor grade. Conclusions: Our observations indicate that age and pathological grade can negatively affect survival of individuals with prostate cancer in Iran.

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Section: Discussionmentioning

confidence: 99%

Survival of Patients with Prostate Cancer in Yazd, Iran

Zahir

Nazemian²,

Zand³

et al. 2014

Asian Pacific Journal of Cancer Prevention

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“…Obese men have been shown to exhibit reduced levels of androgens (51), and there is evidence that men with lower levels of testosterone have more aggressive tumors at clinical presentation (52,53). The influence of early-life exposures is suspected to be important in prostate cancer etiology (13) as carcinogenic processes have been seen within prostatic tissue in men in their 20s (14).…”

Section: Articlementioning

confidence: 99%

Prediagnostic Body Mass Index Trajectories in Relation to Prostate Cancer Incidence and Mortality in the PLCO Cancer Screening Trial

Kelly

Graubard

Andreotti³

et al. 2016

JNCI J Natl Cancer Inst

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Background: Evidence suggests that obesity in adulthood is associated with increased risk of "clinically significant" prostate cancer. However, studies of body mass index (BMI) across the adult life course and prostate cancer risks remain limited. Methods: In a prospective cohort of 69 873 men in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial, we examined associations of prediagnostic BMI across the adult life course with risk of incident prostate cancer and fatal prostate cancer (prostate cancer-specific mortality). At 13 years of follow-up, we identified 7822 incident prostate cancer cases, of which 3078 were aggressive and 255 fatal. BMI trajectories were determined using latent-class trajectory modeling. Cox proportional hazards regression was used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). Results: BMI at age 20 years, 50 years, and baseline questionnaire (mean age ¼ 63 years) were associated with increased risks of fatal prostate cancer (HRs ¼ 1.27-1.32 per five-unit increase). In five BMI trajectories identified, fatal prostate cancer risk was increased in men who had a normal BMI (HR ¼ 1.95, 95% CI ¼ 1.21 to 3.12) or who were overweight (HR ¼ 2.65, 95% CI ¼ 1.35 to 5.18) at age 20 years and developed obesity by baseline compared with men who maintained a normal BMI. Aggressive and nonaggressive prostate cancer were not associated with BMI, and modest inverse associations were seen for total prostate cancer. Conclusions: Our results suggest that BMI trajectories during adulthood that result in obesity lead to an elevated risk of fatal prostate cancer.

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“…Controversy exists with respect to the induction of high-grade cancer by 5ARIs, since both the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial showed a small increase in Gleason ≥8 in the 5ARI arm. 9,10 Although the FDA published a subsequent warning, 15 investigators believe that the increase reflected ascertainment bias. 16 Prostate cancer mortality from high-grade disease in the PCPT was the same in both groups, suggesting that the increase was artifactual.…”

Section: Discussionmentioning

confidence: 99%

Effect of dutasteride in men receiving intermittent androgen ablation therapy: The AVIAS trial

Klotz

Nabid

Higano

et al. 2014

CUAJ

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Cite as: Can Urol Assoc J 2014;8(11-12):e789-94. http://dx.doi.org/10.5489/cuaj.2332 Published online November 24, 2014. Abstract Introduction:We studied the effect of dutasteride on the length of the off-treatment period in prostate cancer patients on intermittent androgen deprivation (IAD) therapy. Methods: We conducted a randomized, placebo-controlled Phase II trial in men with localized prostate cancer and a rising prostatespecific antigen (PSA) level post-primary treatment. Patients were randomized to dutasteride (0.5 mg/day) or placebo. All patients received androgen deprivation therapy (ADT), which was stopped at month 9 if the PSA level was <1.0 ng/mL. ADT was resumed when PSA increased to ≥5.0 ng/mL. End points included time off treatment, PSA nadir after 9 months of ADT, serum testosterone and dihydrotestosterone levels, and time to castrate-resistant prostate cancer (rising PSA while testosterone levels remain <50 ng/mL). Results: There were 87 evaluable patients: 49 dutasteride, 38 placebo. In total, 80 patients completed one treatment cycle: 45 dutasteride, 35 placebo. The median time off treatment for patients reaching ≥5 ng/mL was 18.6 and 16.7 months for dutasteride and placebo, respectively (p = 0.7600). The median PSA nadir at 9 months was 0.1 and 0.075 ng/mL, respectively (p = 0.4486). There were no cases of androgen-independent prostate cancer. Our study limitations include its short duration with only one treatment cycle evaluated. Conclusions: This small-scale Phase II randomized controlled trial showed no benefit to the addition of dutasteride to an IAD regimen.

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The Risks and Benefits of 5α-Reductase Inhibitors for Prostate-Cancer Prevention

Cited by 151 publications

References 5 publications

Survival of Patients with Prostate Cancer in Yazd, Iran

Survival of Patients with Prostate Cancer in Yazd, Iran

Prediagnostic Body Mass Index Trajectories in Relation to Prostate Cancer Incidence and Mortality in the PLCO Cancer Screening Trial

Effect of dutasteride in men receiving intermittent androgen ablation therapy: The AVIAS trial

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