A Big Study Yields Big Questions

Zuger, Abigail

doi:10.1056/nejmp038121

Cited by 27 publications

(12 citation statements)

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“…The PCPT was a 7-year randomized, double-blind, placebo-controlled trial of the efficacy of finasteride for the prevention of prostate cancer [1, 12]. The primary outcome for the trial was prevalence of prostate cancer as measured by a transrectal ultrasonographic-guided biopsy of the prostate (minimum of six cores) at the end of 7 years or an interim diagnosis of prostate cancer.…”

Section: Methodsmentioning

confidence: 99%

Factors Associated with Adherence to an End-of-Study Biopsy: Lessons from the Prostate Cancer Prevention Trial (SWOG-Coordinated Intergroup Study S9217)

Gritz

Arnold

Moinpour

et al. 2014

Cancer Epidemiology, Biomarkers &Amp; Prevention

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Background The Prostate Cancer Prevention Trial (PCPT) was a 7-year randomized, double-blind, placebo-controlled trial of the efficacy of finasteride for the prevention of prostate cancer with a primary outcome of histologically-determined prevalence of prostate cancer at the end of 7 years. Methods A systematic modeling process using logistic regression identified factors available at year 6 that are associated with end-of-study (EOS) biopsy adherence at year 7, stratified by whether participants were ever prompted for a prostate biopsy by year 6. Final models were evaluated for discrimination. At year 6, 13,590 men were available for analysis. Results Participants were more likely to have the EOS biopsy if they were adherent to study visit schedules and procedures and/or were in good health (p<.01). Participants at larger sites and/or sites that received retention and adherence grants were also more likely to have the EOS biopsy (p<.05). Conclusions Our results show good adherence to study requirements one year prior to the EOS biopsy was associated with greater odds that a participant would comply with the invasive EOS requirement. Impact Monitoring adherence behaviors may identify participants at risk of non-adherence to more demanding study end points. Such information could help frame adherence intervention strategies in future trials.

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Section: Methodsmentioning

confidence: 99%

Factors Associated with Adherence to an End-of-Study Biopsy: Lessons from the Prostate Cancer Prevention Trial (SWOG-Coordinated Intergroup Study S9217)

Gritz

Arnold

Moinpour

et al. 2014

Cancer Epidemiology, Biomarkers &Amp; Prevention

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show abstract

“…Unfortunately, the trial employing finasteride that was meant to resolve the viability of chemoprevention in prostate cancer was aptly called 'the big study that yielded big questions' [13]. The Prostate Cancer Prevention Trial (PCPT) involved 18,882 men randomized to finasteride or placebo and ended more than 1 year earlier than planned because the data safety and monitoring committee determined that the trial had met its primary objective.…”

Section: Chemoprevention Trialsmentioning

confidence: 99%

Chemoprevention of prostate cancer: breakthroughs and controversies

Kim

2010

Expert Review of Anticancer Therapy

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“…This randomized placebo-controlled clinical trial enrolled nearly 19,000 men, 55 or over, with PSA levels of 3 ng/ml or under [ 26]. The men in the trial were treated with the 5-alpha reductase inhibitor finasteride, which lowers testosterone levels, or a placebo, and treatment was followed with periodic PSA tests and digital rectal exams for seven years.…”

Section: Screening Testsmentioning

confidence: 99%