The Influence of Finasteride on the Development of Prostate Cancer

Thompson, Ian M.; Goodman, Phyllis J.; Tangen, Catherine M.; Lucia, M. Scott; Miller, Gary J.; Ford, Leslie G.; Lieber, Michael M.; Cespedes, R. Duane; Atkins, James N.; Lippman, Scott M.; Carlin, Susie M.; Ryan, Anne; Szczepanek, Connie M.; Crowley, John; Coltman, Charles A.

doi:10.1056/nejmoa030660

Cited by 2,453 publications

(1,721 citation statements)

References 21 publications

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“…The hypothesis that finasteride shrinks existing tumors is supported by the observation that the rates of prostate cancer in men treated with finasteride and placebo diverged early in PCPT. 9 Although the model is unable to shed further light on this topic, it appears possible that using finasteride resulted in a mixture of primary prevention and prevention of tumor progression in PCPT.…”

Section: Discussionmentioning

confidence: 99%

“…14,15 Dividing the detection rates from PCPT by these calculated true detection rates provided a detection probability, which was then applied to the model using average prostate volumes of 34 (placebo group) and 26 cc (finasteride group), representing median prostate volumes at the end of study biopsy. 9 Table 1 shows the minimum number of PZ and TZ biopsy cores needed for a 0.90 or greater probability of cancer detection for a total tumor volume of 1.0 and 3.0 cc by prostate volume. As would be expected, an increasing number of biopsies were required to ensure a probability of 0.90 or greater as prostate volume increased and tumor volume decreased.…”

Section: Modeling the Influence Of Prostate Volume And Tumor Size Redmentioning

confidence: 99%

“…This hypothesis was cast into sharp relief by PCPT findings. 9 During the course of the trial the prostate cancer prevalence was 24.8% lower in the finasteride vs the placebo arm, as detected in for cause biopsies triggered by abnormal PSA and/or digital rectal examination, or on mandatory end of study biopsy. However, Gleason grade 7-10 tumors were significantly more common in the finasteride group than in the placebo group throughout the study duration, raising the concern that finasteride might promote the growth of more aggressive tumors.…”

mentioning

confidence: 96%

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Quantifying the Impact of Prostate Volumes, Number of Biopsy Cores and 5α-Reductase Inhibitor Therapy on the Probability of Prostate Cancer Detection Using Mathematical Modeling

et al. 2007

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Purpose: Previous studies demonstrated a negative correlation between prostate volume and biopsy yield. By decreasing prostate volume 5␣-reductase inhibitors may enhance cancer detection, which may explain the greater detection of high grade tumors in the finasteride arm of the Prostate Cancer Prevention Trial. Materials and Methods: A mathematical model was constructed to analyze the effects of prostate and tumor volumes, and biopsy core number on cancer detection. The effects of the volume reduction observed with finasteride in the Prostate Cancer Prevention Trial were also modeled, as was the potential reduction in tumor volume needed to explain the observed difference in prostate cancer detection. The model was also applied to the Reduction by Dutasteride of Prostate Cancer Events study. Results: A higher number of biopsies are required to ensure a detection probability of 0.90 or greater in larger glands or with smaller tumors. In the Prostate Cancer Prevention Trial for a tumor volume of 1 cc a 17% increase in the detection rate in the finasteride arm would be predicted if there was no change in tumor volume, likewise the rate would be 11% to 17% for the dutasteride arm of the Reduction by Dutasteride of Prostate Cancer Events study. The calculated reduction in tumor volume needed to explain the difference in cancer detection between the finasteride and placebo arms of the Prostate Cancer Prevention Trial would be 51% to 66%. Conclusions: This model provides guidance on the optimal number of biopsy cores that accord with an earlier model. These findings also suggest that, if there were no reduction in tumor volume, 5␣-reductase inhibitor therapy could lead to excess cancer detection, including high grade tumors.

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Section: Discussionmentioning

confidence: 99%

Section: Modeling the Influence Of Prostate Volume And Tumor Size Redmentioning

confidence: 99%

mentioning

confidence: 96%

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Quantifying the Impact of Prostate Volumes, Number of Biopsy Cores and 5α-Reductase Inhibitor Therapy on the Probability of Prostate Cancer Detection Using Mathematical Modeling

et al. 2007

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“…One phase III study examining finasteride has been completed and results have shown a 25% reduction in the period prevalence of PCa over 7 years. 1 Although initially the development of high-grade PCa under finasteride treatment was viewed as a detrimental effect, 1 recently published new analyses demonstrated this to be an artifact, and in fact, these analyses suggest overall a 30% reduction in the period prevalence of PCa under finasteride with no increased risk for high-grade cancer. [2][3][4][5] Dutasteride 6 is also currently being evaluated in phase III placebo-controlled trials.…”

Section: Introductionmentioning

confidence: 99%

First-year costs of treating prostate cancer: estimates from SEER-Medicare data

Roehrborn

Albertsen

Stokes

et al. 2009

Prostate Cancer Prostatic Dis

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Pharmacologic therapies are currently being evaluated for the prevention of prostate cancer (PCa). As additional clinical data become available regarding their benefits and risks, an examination of their economic impact will also be important. The purpose of this study was to estimate mean per patient PCa-related costs during the first year following diagnosis and to examine the extent to which initial therapies are used, by initial cancer stage. Our data show that health-care costs were significant and varied by stage. With average first-year PCa-related costs of US$13 091, prevention strategies have the potential to reduce health-care costs.

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“…By contrast, a variety of studies, using various designs and testosterone formulations, over periods ranging from several months to 15 years, in men with a wide range of ages, have not revealed an increased risk of prostate cancer [139][140][141][142][143][144][145][146][147][148][149][150][151][152][153][154]. A meta-analysis found that testosterone treatment in older men compared to placebo was not associated with a significantly higher risk of detection of prostate cancer [131], although the frequency of prostate biopsies was much higher in the testosterone-treated group than in the placebo group [131].…”

Section: Lower Urinary Tract Symptoms and Prostate Diseasementioning

confidence: 97%

Androgens and male aging: current evidence of safety and efficacy

Gooren¹

2010

Asian J Androl

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Many signs of aging, such as sexual dysfunction, visceral obesity, impaired bone and muscle strength, bear a close resemblance to features of hypogonadism in younger men. The statistical decline of serum testosterone in aging men is solidly documented. It has been presumed that the above features of aging are related to the concurrent decline of androgens, and that correction of the lower-than-normal circulating levels of testosterone will lead to improvement of symptoms of aging. But in essence, the pivotal question whether the age-related decline of testosterone must be viewed as hypogonadism, in the best case reversed by testosterone treatment, has not been definitively resolved. Studies in elderly men with lower-than-normal testosterone report improvement of features of the metabolic syndrome, bone mineral density, of mood and of sexual functioning. But as yet there is no definitive proof of the beneficial effects of restoring testosterone levels to normal in elderly men on clinical parameters. Few of these studies meet as yet rigorous standards of scientific enquiry: double-blind, placebo-controlled design of the study. The above applies also to the assessment of safety of testosterone administration to elderly men. There is so far no convincing evidence that testosterone is a main factor in the development of prostate cancer in elderly men and guidelines for monitoring the development of prostate disease have been developed. It is of note that there are presently no long-term safety data with regard to the prostate. Polycythemia is another potential complication of testosterone treatment. It is dose dependent and can be managed with dose adjustment.

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The Influence of Finasteride on the Development of Prostate Cancer

Abstract: Finasteride prevents or delays the appearance of prostate cancer, but this possible benefit and a reduced risk of urinary problems must be weighed against sexual side effects and the increased risk of high-grade prostate cancer.

Cited by 2,453 publications

References 21 publications

Quantifying the Impact of Prostate Volumes, Number of Biopsy Cores and 5α-Reductase Inhibitor Therapy on the Probability of Prostate Cancer Detection Using Mathematical Modeling

Quantifying the Impact of Prostate Volumes, Number of Biopsy Cores and 5α-Reductase Inhibitor Therapy on the Probability of Prostate Cancer Detection Using Mathematical Modeling

First-year costs of treating prostate cancer: estimates from SEER-Medicare data

Androgens and male aging: current evidence of safety and efficacy

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