The Prostate Cancer Prevention Trial - National Cancer Institute

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Introduction

The Prostate Cancer Prevention Trial, or PCPT, is a study designed to see whether the drug finasteride (trade name Proscar) can prevent prostate cancer in men ages 55 and older. (See a summary of the protocol.)

Prostate Cancer Prevention Trial In June 2003, the PCPT was stopped early because of a clear finding that finasteride reduced the incidence of prostate cancer. However, those trial participants who did develop prostate cancer while taking finasteride experienced a slightly higher incidence of high-grade tumors. Researchers analyzing the data have shown that because men taking finasteride have a reduced prostate size, this contributes to finding more high-grade tumors on biopsy. Additionally, researchers also found that high-grade cancer was detected earlier and in a less extensive stage in the finasteride group than in the placebo group.

Specimens from the PCPT biorepository are also available for research by other groups. Guidelines on how to get access to the PCPT biospecimens were released in late 2006.

The links on the left of this page will take you to more detailed information about the trial and its results so far.

Prostate cancer is a critical public health problem: more than 220,000 men will be diagnosed with prostate cancer in the United States this year and almost 29,000 will die of the disease.

PCPT-At-A-Glance

Main Objective
To see whether the drug finasteride (Proscar™) can prevent prostate cancer in men age 55 and older.

Enrollment Period
October 1993 - May 1997

Participants
18,882 men: 92 percent white, 4 percent African American, 4 percent other races/ethnicities

Intervention
Men were randomly assigned to take either 5 milligrams of finasteride or a placebo (dummy pill) once daily for seven years. All men had an annual digital rectal exam and prostate-specific antigen (PSA) test. At the end of the seven years, men who had not been diagnosed with prostate cancer were asked to have a prostate biopsy to see if they were truly cancer free.

Criteria for Participation

Men, age 55 and older
General good health
No evidence of prostate cancer at beginning of trial
Prostate Specific Antigen (PSA) 3 ng/ml
Willing to have a prostate biopsy at the end of the study

Study Sites
222 centers, located in the United States and Canada

Additional Study Objectives

To determine if finasteride affects the stage and grade of prostate cancers
To see if finasteride affects the number of deaths from prostate cancer and the number of deaths from all cancers
To see if finasteride changes the occurrence and type of noncancerous prostate growth
To estimate the accuracy of digital rectal exam and PSA testing -- separately and together -- in detecting whether a man has prostate cancer
To measure how long-term treatment with finasteride affects a man's urinary and sexual function

The following links will take you to press releases and other materials concerning the Prostate Cancer Prevention Trial that have been prepared by the National Cancer Institute's Office of Communications and Education:

Press Releases

Some Men with Low PSAs Have Prostate Cancer
(Posted: 05/26/2004) - Men with low PSA (prostate specific antigen) levels on screening tests can still have prostate cancer, according to a study released today by scientists from the National Cancer Institute (NCI), part of the National Institutes of Health, and the Southwest Oncology Group, an NCI-funded network of researchers.

First Prostate Cancer Prevention Drug Found, But Not All Men Benefit: NCI Announces Results of Prostate Cancer Prevention Trial
(Posted: 06/24/2003) - Men who took finasteride, a drug that affects male hormone levels, reduced their chances of getting prostate cancer by nearly 25 percent compared to men who took a placebo, according to results of a national study released today online by the New England Journal of Medicine. Questions and Answers

Se encuentra el primer medicamento para la prevención del cáncer de próstata, aunque no todos los hombres se benefician: El NCI anuncia los resultados del Estudio de Prevención del Cáncer de Próstata (PCPT)
(Publicación: 06/24/2003) - Los hombres que tomaron finasterida, un medicamento que afecta las concentraciones de hormona masculina, redujeron en cerca de un veinticinco por ciento su probabilidad de tener cáncer de próstata, comparados con quienes tomaron placebo, según los resultados de un estudio nacional divulgado hoy en línea por el New England Journal of Medicine.

Questions & Answers

Prostate Cancer Prevention Trial (PCPT): Questions and Answers
(Posted: 06/24/2003, Updated: 05/18/2008) - In the Prostate Cancer Prevention Trial (PCPT), 25 percent fewer men taking the drug finasteride developed prostate cancer than men not taking the drug. However, men who developed prostate cancer while taking finasteride were more likely to have high-grade cancers, which can spread quickly even if the tumors are small.

Estudio de Prevención del Cáncer de Próstata (PCPT): preguntas y respuestas
(Publicación: 06/24/2003, Actualización: 06/06/2008) - En el Estudio de Prevención del Cáncer de Próstata (PCPT), un 25 por ciento menos de hombres que tomaron finasterida desarrollaron cáncer de próstata, comparado con los que no tomaron el medicamento. Sin embargo, los hombres que desarrollaron cáncer de próstata mientras tomaban finasterida tuvieron más probabilidad de desarrollar cánceres de grado elevado, los cuales se pueden diseminar rápidamente aunque los tumores sean pequeños.

NCI Cancer Bulletin

Finasteride Not Linked to High-Grade Prostate Cancers
According to two studies in the September 11, 2007, issue of the Journal of the National Cancer Institute, finasteride is unlikely to induce high-grade prostate cancers in men who take the drug to prevent the disease.

Prostate Cancer Risk Calculator Available Online
Researchers have developed an online statistical tool for estimating an individual's risk of developing prostate cancer. The risk calculator is designed to help certain men and their physicians evaluate the potential risks and benefits of being screened for prostate cancer.

Prostate Cancer PSA Testing Limitations Demonstrated
A large-scale study of prostate-specific antigen (PSA) screening for prostate cancer concluded that, contrary to current clinical practice, there is no definitive "cutpoint" PSA level to determine the level of risk for the disease, according to the July 6, 2005, issue of the Journal of the American Medical Association.

NCI Communicates Information on First Prostate Cancer Prevention Trial
An article in the July-August, 2004, issue of Urologic Oncology describes the communication techniques used by NCI to deliver information to the public about the results of the Prostate Cancer Prevention Trial (PCPT).

No "Magic Threshold" for PSA Screening, Study Finds
Data from the National Cancer Institute's (NCI) Prostate Cancer Prevention Trial (PCPT) published recently showed that a substantial number of men enrolled in the trial as controls were found to have prostate cancer despite consistently normal screening tests over the study period. The study results were published in the May 27, 2004, New England Journal of Medicine.

Studies Make Case for Finasteride to Prevent Prostate Cancer
Three new analyses of data from a large prostate cancer prevention trial bolster the case for finasteride as a preventive agent against prostate cancer, according to an article published online May 18, 2008, by the journal Cancer Prevention Research.

The following citations are of reports that have been published in the scientific literature concerning the Prostate Cancer Prevention Trial (PCPT). The citations are listed in reverse chronological order.

2007 Publications

Detection bias due to the effect of finasteride on prostate volume: a modeling approach for analysis of the Prostate Cancer Prevention Trial

Authors: YC Cohen, KS Liu, NL Heyden, AC Carides, KM Anderson, AG Daifotis, PH Gann
Journal: Journal of the National Cancer Institute 99(18):1366-1374. (2007).

Finasteride and high-grade prostate cancer in the Prostate Cancer Prevention Trial

Authors: SM Lucia, JI Epstein, PJ Goodman, AK Darke, VE Reuter, F Civantos, CM Tangen, HL Parnes, SM Lippman, FG LaRosa, MW Kattan, ED Crawford, LG Ford, CA Coltman Jr., IM Thompson
Journal: Journal of the National Cancer Institute 99(18): 1375-1383. (2007).

Prediction of prostate cancer for patients receiving finasteride: results from the Prostate Cancer Prevention Trial

Authors: IM Thompson, D Pauler Ankerst, C Chi, PJ Goodman, CM Tangen, SM Lippman, MS Lucia, HL Parnes, CA Coltman, Jr.
Journal: Journal of Clinical Oncology 25(21):3076-3081. (2007).

Longitudinal analysis of sexual function reported by men in the Prostate Cancer Prevention Trial

Authors: CM Moinpour, AK Darke, GW Donaldson, IM Thompson, C Langley, DP Ankerst, DL Patrick, JE Ware, PA Ganz, SA Shumaker, SM Lippman, CA Coltman, Jr.
Journal: Journal of the National Cancer Institute 99(13):1025-1035. (2007).

Race/ethnicity, obesity, health related behaviors and the risk of symptomatic benign prostatic hyperplasia: results from the prostate cancer prevention trial

Authors: AR Kristal, KB Arnold, JM Schenk, ML Neuhouser, N Weiss, P Goodman, CM Antvelink, DF Penson, IM Thompson
Journal: Journal of Urology 177(4):1395-1400. (2007).

Longitudinal analysis of sexual function reported by men in the Prostate Cancer Prevention Trial

Authors: CM Moinpour, AK Darke, GW Donaldson, IM Thompson, C Langley, DP Ankerst, DL Patrick, JE Ware, PA Ganz, SA Shumaker, SM Lippman, CA Coltman, Jr.
Journal: Journal of the National Cancer Institute 99 (13): 1025-1035. (2007).

2006 Publications

The prostate cancer prevention trial: design, biases and interpretation of study results

Authors: PJ Goodman, IM Thompson, CM Tangen, JJ Crowley, LG Ford, CA Coltman, Jr.
Journal: Journal of Urology 175 (6): 2234-2242. (2006).

Effect of finasteride on the sensitivity of PSA for detecting prostate cancer

Authors: IM Thompson, C Chi, DP Ankerst, PJ Goodman, CM Tangen, SM Lippman, MS Lucia, HL Parnes, CA Coltman, Jr.
Journal: Journal of the National Cancer Institute 98(16):1128-1133. (2006).

Assessing prostate cancer risk: results from the Prostate Cancer Prevention Trial

Authors: IM Thompson, DP Ankerst, C Chi, PJ Goodman, CM Tangen, MS Lucia, Z Feng, HL Parnes, CA Coltman, Jr.
Journal: Journal of the National Cancer Institute 98(8):529-534. (2006).

2005 Publications

Long-term effects of finasteride on prostate specific antigen levels: results from the prostate cancer prevention trial

Authors: RD Etzioni, N Howlader, PA Shaw, DP Ankerst, DF Penson, PJ Goodman, IM Thompson
Journal: Journal of Urology 174(3):877-881. (2005).

Operating characteristics of prostate-specific antigen in men with an initial PSA level of 3.0 ng/ml or lower

Authors: IM Thompson, DP Ankerst, C Chi, MS Lucia, PJ Goodman, JJ Crowley, HL Parnes, CA Coltman, Jr.
Journal: Journal of the American Medical Association 294(1):66-70. (2005).

Estimated impact of the prostate cancer prevention trial on population mortality

Authors: JM Unger; IM Thompson; M LeBlanc; JJ Crowley; PJ Goodman; LG Ford; CA Coltman, Jr.
Journal: Cancer 103(7):1375-1380. (2005).

Pathological assessment of high grade tumors in the Prostate Cancer Prevention Trial (PCPT)

Authors: MS Lucia; A Darke; P Goodman; C Tangen; CA Coltman; IM Thompson.
Journal: Journal of Urology 173(4):451 (#1664). (2005).

Prostate specific antigen (PSA) as a predictor of adverse pathological features at prostatectomy in the Prostate Cancer Prevention Trial (PCPT)

Authors: MS Lucia; P Goodman; C Tangen; CA Coltman; IM Thompson.
Journal: Journal of Urology 173(4):143 (#525). (2005).

The performance characteristics of prostate-specific antigen

Authors: IM Thompson; DP Ankerst; C Chi; P Goodman; C Tangen; CA Coltman, Jr.
Journal: Journal of Urology 173(4):143 (#526). (2005).

2004 Publications

Implementation of the prostate cancer prevention trial (PCPT)

Authors: PJ Goodman; CM Tangen; JJ Crowley; SM Carlin; A Ryan; CA Coltman, Jr.; LG Ford; IM Thompson.
Journal: Controlled Clinical Trials 2:203-222. (2004).

Prevalence of prostate cancer among men with a prostate-specific antigen level < 4.0 ng per milliliter

Authors: IM Thompson; DK Pauler; PJ Goodman; CM Tangen; MS Lucia; HL Parnes; LM Minasian; LG Ford; SM LIppman; ED Crawford; JJ Crowley; CA Coltman Jr.
Journal: New England Journal of Medicine 350(22):2239-2246. (2004).

Prostate cancer chemoprevention: an overview of United States trials

Authors: A Barqawi; IM Thompson; ED Crawford.
Journal: Journal of Urology 171:S5-S9. (2004).

The person-years saved model and other methodologies for assessing the population impact of cancer-prevention strategies

Authors: JM Unger; M LeBlanc; IM Thompson; CA Coltman, Jr.
Journal: Urologic Oncology: Seminars and Original Investigations 22:362-368. (2004).

2003 Publications

The influence of finasteride on the development of prostate cancer

Authors: IM Thompson; PJ Goodman; CM Tangen; MS Lucia; GJ Miller; LG Ford; MM Lieber; RD Cespedes; JN Atkins; SM Lippman; SM Carlin; A Ryan; CM Szczepanek; JJ Crowley; CA Coltman, Jr.
Journal: New England Journal of Medicine 349:215-224. (2003).

The prostate cancer prevention trial: design, status, and promise

Authors: IM Thompson; C Tangen; P Goodman.
Journal: World Journal of Urology 21:28-30. (2003).

2002 Publications

Biomarker-based methods for determining noncompliance in a prevention trial.

Authors: DK Pauler, KB Gower, PJ Goodman, JJ Crowley, IM Thompson.
Journal: Controlled Clinical Trials 23:675-685. (2002).

Energy from fat is associated with obesity in US men: results from the prostate cancer prevention trial.

Authors: J Satia-Abouta, RE Patterson, RN Schiller, AR Kristal.
Journal: Preventive Medicine 34:493-501. (2002).

2001 Publications

The prostate cancer prevention trial: current status and lessons learned.

Authors: IM Thompson, M Kouril, EA Klein, CA Coltman, A Ryan, P Goodman.
Journal: Urology 57(Suppl.4A):230-234. (2001).

Promoting adherence to the prostate cancer prevention trial end of study biopsy requirement. (Abstract not available online)

Authors: AM Ryan, P Goodman, S Hill, C Moinpour.
Journal: Controlled Clinical Trials 22(2S):88S(#P71). (2001).

Dietary supplement use in the prostate cancer prevention trial: implications for prevention trials.

Authors: ML Neuhouser, AR Kristal, RE Patterson, PJ Goodman, IM Thompson.
Journal: Nutrition and Cancer 39(1):12-18. (2001).

2000 Publications

Letter to the Editor: RE: RE: Chemoprevention of urological cancer.

Authors: IM Thompson, CA Coltman.
Journal: Journal of Urology 164(4):1321-1322. (2000).

Profile of men randomized to the prostate cancer prevention trial: Baseline health-related quality of life, urinary and sexual functioning, and health behaviors.

Authors: CM Moinpour, L Lovato, IM Thompson, JE Ware, PA Ganz, DL Patrick, SA Shumaker, GW Donaldson, A Ryan, CA Coltman.
Journal: Journal of Clinical Oncology 18(9):1942-1953. (2000).

Television and news print media are effective in recruiting potential participants in a prostate cancer chemoprevention trial. (Abstract not available online)

Authors: TDK Chung, II Park, L Ignacio, R Catchatourian, MA Kopnick, E Davison, G Conrad, AM Awan, ED Crawford, S Vijayakumar.
Journal: International Journal of Cancer 90:302-304. (2000).

Minority recruitment in the prostate cancer prevention trial. (Abstract not available online)

Authors: CM Moinpour, JO Atkinson, SM Thomas, S Millon-Underwood, C Harvey, J Parzuchowski, LC Lovato, AM Ryan, S Hill, E DeAntoni, ER Gritz, IM Thompson, Jr, CA Coltman, Jr.
Journal: Annals of Epidemiology 10(S8):S85-S91. (2000).

1999 Publications

Letters to the Editor: The effect of finasteride on the prostate gland in men with elevated serum prostate-specific antigen level.

Author: CA Coltman.
Journal: British Journal of Cancer 81(1):184-185. (1999).

Validity of short food frequency questionnaires used in cancer chemoprevention trials: results from the prostate cancer prevention trial. (Abstract not available online)

Authors: ML Neuhouser, AR Kristal, D McLerran, RE Patterson, J Atkinson.
Journal: Cancer Epidemiology Biomarkers & Prevention 8:721-725. (1999).

Prostate cancer prevention trial (PCPT) update.

Authors: CA Coltman Jr, IM Thompson Jr, P Feigl.
Journal: European Urology 35:544-547. (1999).

1998 Publications

Army and Air Force leadership in the prostate cancer prevention trial.

Authors: J Allerton, T Seay, S Optenberg, CA Coltman Jr, B Higgins, I Thompson, L Lovato.
Journal: Urology 51(Suppl.4A):64-66. (1998).

1997 Publications

Chemoprevention of prostate cancer: The prostate cancer prevention trial.

Authors: IM Thompson, CA Coltman Jr, J Crowley.
Journal: The Prostate 33:217-221. (1997).

Data operations management with clinical datafax: The prostate cancer prevention trial (PCPT) experience. (Abstract not available online)

Authors: AM Ryan, L Emel, P Goodman.
Journal: Controlled Clinical Trials 18(S3)(#P74):156S. (1997).

Utility of the enrollment period in the prostate cancer prevention trial (PCPT). (Abstract not available online)

Authors: PJ Goodman, L Lovato, A Ryan, J Crowley, C Moinpour, I Thompson.
Journal: Controlled Clinical Trials 18(S3)(#19):52S. (1997).

1996 Publications

Prostate cancer prevention trial. (Abstract not available online)

Author: BH Zoltick.
Presented at the AUAA Annual Assembly-Orlando Florida May 4-7 :. (1996).

Screening for prostate cancer: Opportunities for prevention. (Abstract not available online)

Authors: IM Thompson, CA Coltman Jr.
Journal: Seminars in Urologic Oncology 14(2)(Suppl.2):4-11. (1996).

The prostate cancer prevention trial: Efforts to increase the recruitment of minority participants. (Abstract not available online)

Author: CM Moinpour.
Poster for Conf on the Recruit and Retention of Min Parts in CCR 1/26-27/96 :. (1996).

1995 Publications

Chemoprevention of prostate cancer with finasteride: An Intergroup trial. (Abstract not available online)

Authors: CA Coltman Jr, P Feigl, IM Thompson.
Journal: Cancer Investigation 13(Suppl.1):43(#36). (1995).

Chemoprevention of prostate cancer with finasteride.

Authors: I Thompson, P Feigl, C Coltman.
Journal: Important Advances in Oncology, JB Lippincott Co :57-76. (1995).

Chemoprevention of prostate cancer.

Authors: IM Thompson, CA Coltman, OW Brawley, A Ryan.
Journal: Seminars in Urology 13(2):122-129. (1995).

Design of the prostate cancer prevention trial (PCPT).

Authors: P Feigl, B Blumenstein, I Thompson, J Crowley, M Wolf, BS Kramer, CA Coltman Jr, OW Brawley, LG Ford.
Journal: Controlled Clinical Trials 16:150-163. (1995).

1994 Publications

Chemoprevention of prostate cancer with finasteride, an Intergroup trial. (Abstract not available online)

Authors: CA Coltman Jr, J Unger, IM Thompson.
Journal: Annals of Oncology [Corrigendum6(6)621-1995]5(Suppl.8):65(#P324). (1994).

Prostate cancer prevention: Risk reduction through life-style, diet, and chemoprevention.

Authors: KE Greco, L Kulawiak.
Journal: Oncology Nursing Forum 21(9):1504-1511. (1994).

The prostate cancer prevention trial. A low-risk, high-accrual study. (Abstract not available online)

Author: J O'Connor.
Journal: Oncology Issues 9(5):20-24. (1994).

The following links will take you to multimedia related to the Prostate Cancer Prevention Trial:

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