Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Alternate Title

Finasteride in Preventing the Recurrence of Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Prevention Completed 55 and over NCI SWOG-9217 PCPT-1, NCI-P93-0049

Objectives

I.  Determine the efficacy (i.e., decrease in tumor initiation, promotion, or 
progression rate) of long-term (7-year) treatment with finasteride (Proscar, 
MK-906) in reducing the incidence of prostate cancer in men aged 55 and older.

II.  Assess the effect of MK-906 on the stage and grade of prostate cancer at 
time of diagnosis.

III.  Assess the toxicity and side effects of MK-906 administered on this 
schedule.

IV.  Estimate total mortality and prostate cancer-specific mortality in men 
treated with MK-906 versus placebo.

V.  Estimate the incidence and severity of benign prostatic hyperplasia in men 
treated with MK-906 versus placebo.

VI.  Estimate the sensitivity, specificity, and predictive values of digital 
rectal examination (DRE), prostate-specific antigen (PSA), and PSA plus DRE as 
screening tests for the detection of prostate cancer and determine the effect 
of long-term treatment with MK-906 on these screening parameters.

VII.  Assess the effect of long-term treatment with MK-906 on participants' 
self-report of urinary and sexual function symptoms and other quality-of-life 
dimensions.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Prior/Concurrent Therapy:

No concurrent participation in any other clinical trial

Biologic therapy:
  Not specified

Chemotherapy:
  No prior finasteride (Proscar)
  No prior chemotherapy for cancer

Endocrine therapy:
  No prior anabolic steroids
  No prior hormonal therapy for cancer

Radiotherapy:
  No prior radiotherapy for cancer

Surgery:
  At least 6 months since transurethral resection of the
     prostate

Patient Characteristics:

Age:
  55 and older

Performance status:
  SWOG 0

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Cardiovascular:
  No MI within 3 months
  No active angina
  No unstable heart rhythm
  No clinically evident CHF

Other:
  No requirement for anticoagulation therapy (e.g., coumadin)
     Aspirin taken as anticoagulation therapy allowed
  No uncontrolled diabetes
  No uncontrolled peptic ulcer disease
  No HIV positivity
  No other medical illness unless adequately controlled by
     appropriate therapy
  No prior malignancy within 5 years except nonmelanomatous
     skin cancer
  Barrier contraception required
  Willing to complete quality-of-life assessments, as required
  Able and willing to participate in full 7-year study

  Blood/body fluid analyses to determine eligibility and
  imaging studies and physical exams for tumor measurement
  completed within 14 days prior to registration; screening
  exams (other than blood/body fluid analyses) and imaging
  studies of nonmeasurable disease or uninvolved organs
  completed within 42 days prior to registration

General Eligibility Criteria:

Additional referral information for this trial is available
from CancerFax (dial 301-402-5874 from the telephone on your
fax machine) and from the Cancer Information Service
(1-800-422-6237)

--Population Characteristics--

Men of such an age (55 or older) and medical condition that a
physician would anticipate treatment should they be diagnosed
with prostate cancer within 7 years
  Individuals of an advanced age or anticipated medical status
  such that prostate cancer diagnosed on study would not
  require treatment are ineligible

Normal DRE, without induration, asymmetry, or prostate
nodularity, required within 28 days prior to entry

PSA no greater than 3.0 ng/ml on monoclonal assay performed by
the Central Laboratory Facility within 28 days prior to entry

No prior diagnosis of prostate cancer

No urinary retention

No need for immediate medical or surgical treatment of urinary
obstructive symptoms

No severe prostatism as manifested by an AUA symptom score of
20 or more

--Prior/Concurrent Therapy--

No concurrent participation in any other clinical trial

Biologic therapy:
  Not specified

Chemotherapy:
  No prior finasteride (Proscar)
  No prior chemotherapy for cancer

Endocrine therapy:
  No prior anabolic steroids
  No prior hormonal therapy for cancer

Radiotherapy:
  No prior radiotherapy for cancer

Surgery:
  At least 6 months since transurethral resection of the
     prostate

--Patient Characteristics--

Age:
  55 and older

Performance status:
  SWOG 0

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Cardiovascular:
  No MI within 3 months
  No active angina
  No unstable heart rhythm
  No clinically evident CHF

Other:
  No requirement for anticoagulation therapy (e.g., coumadin)
     Aspirin taken as anticoagulation therapy allowed
  No uncontrolled diabetes
  No uncontrolled peptic ulcer disease
  No HIV positivity
  No other medical illness unless adequately controlled by
     appropriate therapy
  No prior malignancy within 5 years except nonmelanomatous
     skin cancer
  Barrier contraception required
  Willing to complete quality-of-life assessments, as required
  Able and willing to participate in full 7-year study

  Blood/body fluid analyses to determine eligibility and
  imaging studies and physical exams for tumor measurement
  completed within 14 days prior to registration; screening
  exams (other than blood/body fluid analyses) and imaging
  studies of nonmeasurable disease or uninvolved organs
  completed within 42 days prior to registration

Expected Enrollment

18,000 subjects will be randomized (9,000/arm) over 3 years.

Outline

Randomized, double-blind, placebo-controlled study.

Arm I:  Chemoprevention.  Finasteride, Proscar, MK-906.

Arm II:  Control.  Placebo, PLCB.

Hoque A, Goodman P, Ambrosone CB, et al.: Extraction of DNA from serum for high-throughput genotyping: findings from pilot studies within the Prostate Cancer Prevention Trial. Urology 71 (5): 967-70, 2008.[PUBMED Abstract]

Kristal AR, Arnold KB, Schenk JM, et al.: Dietary patterns, supplement use, and the risk of symptomatic benign prostatic hyperplasia: results from the prostate cancer prevention trial. Am J Epidemiol 167 (8): 925-34, 2008.[PUBMED Abstract]

Neuhouser ML, Schenk J, Song YJ, et al.: Insulin-like growth factor-I, insulin-like growth factor binding protein-3 and risk of benign prostate hyperplasia in the prostate cancer prevention trial. Prostate 68 (13): 1477-86, 2008.[PUBMED Abstract]

Song Y, Tangen C, Goodman P, et al.: Finasteride, prostate cancer, and weight gain: evidence for genetic or environmental factors that affect cancer outcomes during finasteride treatment. Prostate 68 (3): 281-6, 2008.[PUBMED Abstract]

Thompson IM, Tangen CM, Ankerst DP, et al.: The performance of prostate specific antigen for predicting prostate cancer is maintained after a prior negative prostate biopsy. J Urol 180 (2): 544-7, 2008.[PUBMED Abstract]

Thompson IM, Tangen CM, Lucia MS: The Prostate Cancer Prevention Trial and the future of chemoprevention. BJU Int 101 (8): 933-4, 2008.[PUBMED Abstract]

Thompson IM, Tangen CM, Parnes HL, et al.: Does the level of prostate cancer risk affect cancer prevention with finasteride? Urology 71 (5): 854-7, 2008.[PUBMED Abstract]

Cohen YC, Liu KS, Heyden NL, et al.: Detection bias due to the effect of finasteride on prostate volume: a modeling approach for analysis of the Prostate Cancer Prevention Trial. J Natl Cancer Inst 99 (18): 1366-74, 2007.[PUBMED Abstract]

Kristal AR, Arnold KB, Schenk JM, et al.: Race/ethnicity, obesity, health related behaviors and the risk of symptomatic benign prostatic hyperplasia: results from the prostate cancer prevention trial. J Urol 177 (4): 1395-400; quiz 1591, 2007.[PUBMED Abstract]

Lucia MS, Epstein JI, Goodman PJ, et al.: Finasteride and high-grade prostate cancer in the Prostate Cancer Prevention Trial. J Natl Cancer Inst 99 (18): 1375-83, 2007.[PUBMED Abstract]

Moinpour CM, Darke AK, Donaldson GW, et al.: Longitudinal analysis of sexual function reported by men in the Prostate Cancer Prevention Trial. J Natl Cancer Inst 99 (13): 1025-35, 2007.[PUBMED Abstract]

Thompson IM, Lucia MS, Redman MW, et al.: Finasteride decreases the risk of prostatic intraepithelial neoplasia. J Urol 178 (1): 107-9; discussion 110, 2007.[PUBMED Abstract]

Thompson IM, Pauler Ankerst D, Chi C, et al.: Prediction of prostate cancer for patients receiving finasteride: results from the Prostate Cancer Prevention Trial. J Clin Oncol 25 (21): 3076-81, 2007.[PUBMED Abstract]

Thompson IM, Tangen CM, Goodman PJ, et al.: Finasteride improves the sensitivity of digital rectal examination for prostate cancer detection. J Urol 177 (5): 1749-52, 2007.[PUBMED Abstract]

Goodman PJ, Thompson IM Jr, Tangen CM, et al.: The prostate cancer prevention trial: design, biases and interpretation of study results. J Urol 175 (6): 2234-42, 2006.[PUBMED Abstract]

Thompson IM, Ankerst DP, Chi C, et al.: Assessing prostate cancer risk: results from the Prostate Cancer Prevention Trial. J Natl Cancer Inst 98 (8): 529-34, 2006.[PUBMED Abstract]

Thompson IM, Chi C, Ankerst DP, et al.: Effect of finasteride on the sensitivity of PSA for detecting prostate cancer. J Natl Cancer Inst 98 (16): 1128-33, 2006.[PUBMED Abstract]

Etzioni RD, Howlader N, Shaw PA, et al.: Long-term effects of finasteride on prostate specific antigen levels: results from the prostate cancer prevention trial. J Urol 174 (3): 877-81, 2005.[PUBMED Abstract]

Thompson IM, Ankerst DP, Chi C, et al.: Operating characteristics of prostate-specific antigen in men with an initial PSA level of 3.0 ng/ml or lower. JAMA 294 (1): 66-70, 2005.[PUBMED Abstract]

Thompson IM, Pauler DK, Goodman PJ, et al.: Prevalence of prostate cancer among men with a prostate-specific antigen level < or =4.0 ng per milliliter. N Engl J Med 350 (22): 2239-46, 2004.[PUBMED Abstract]

Thompson IM, Goodman PJ, Tangen CM, et al.: The influence of finasteride on the development of prostate cancer. N Engl J Med 349 (3): 215-24, 2003.[PUBMED Abstract]

Pauler DK, Gower KB, Goodman PJ, et al.: Biomarker-based methods for determining noncompliance in a prevention trial. Control Clin Trials 23 (6): 675-85, 2002.[PUBMED Abstract]

Satia-Abouta J, Patterson RE, Schiller RN, et al.: Energy from fat is associated with obesity in U.S. men: results from the Prostate Cancer Prevention Trial. Prev Med 34 (5): 493-501, 2002.[PUBMED Abstract]

Neuhouser ML, Kristal AR, Patterson RE, et al.: Dietary supplement use in the Prostate Cancer Prevention Trial: implications for prevention trials. Nutr Cancer 39 (1): 12-8, 2001.[PUBMED Abstract]

Ryan AM, Goodman P, Hill S, et al.: Promoting adherence to the prostate cancer prevention trial end of study biopsy requirement. [Abstract] Control Clin Trials 22 (suppl 2): A-P71, 88S, 2001.

Thompson IM Jr, Kouril M, Klein EA, et al.: The Prostate Cancer Prevention Trial: Current status and lessons learned. Urology 57 (4 Suppl 1): 230-4, 2001.[PUBMED Abstract]

Moinpour CM, Lovato LC, Thompson IM Jr, et al.: Profile of men randomized to the prostate cancer prevention trial: baseline health-related quality of life, urinary and sexual functioning, and health behaviors. J Clin Oncol 18 (9): 1942-53, 2000.[PUBMED Abstract]

Neuhouser ML, Kristal AR, Patterson RE, et al.: Dietary supplement use in the prostate cancer prevention trial: implications for the study findings. [Abstract] Proceedings of the American Society of Prevention Oncology A76, 2000.

Coltman CA Jr, Thompson IM Jr, Feigl P: Prostate Cancer Prevention Trial (PCPT) update. Eur Urol 35 (5-6): 544-7, 1999.[PUBMED Abstract]

Neuhouser ML, Kristal AR, McLerran D, et al.: Validity of short food frequency questionnaires used in cancer chemoprevention trials: results from the Prostate Cancer Prevention Trial. Cancer Epidemiol Biomarkers Prev 8 (8): 721-5, 1999.[PUBMED Abstract]

Goodman PJ, Lovato L, Ryan A, et al.: Utility of the enrollment period in the prostate cancer prevention trial (PCPT). [Abstract] Control Clin Trials 18 (3 suppl): A-19, 52S, 1997.

Thompson IM, Coltman CA Jr, Crowley J: Chemoprevention of prostate cancer: the Prostate Cancer Prevention Trial. Prostate 33 (3): 217-21, 1997.[PUBMED Abstract]

Coltman CA Jr, Feigl P, Thompson IM: Chemoprevention of prostate cancer with finasteride: an intergroup trial. [Abstract] Cancer Invest 13 (suppl 1): A-36, 43, 1995.

Thompson IM, Coltman CA, Brawley OW, et al.: Chemoprevention of prostate cancer. Semin Urol 13(2): 122-129, 1995.

Pepe MS, Feng Z, Huang Y, et al.: Integrating the predictiveness of a marker with its performance as a classifier. Am J Epidemiol 167 (3): 362-8, 2008.[PUBMED Abstract]

Etzioni RD, Ankerst DP, Weiss NS, et al.: Is prostate-specific antigen velocity useful in early detection of prostate cancer? A critical appraisal of the evidence. J Natl Cancer Inst 99 (20): 1510-5, 2007.[PUBMED Abstract]

Smith JA: Estimated impact of the Prostate Cancer Prevention Trial on population mortality[commentary]. Urol Oncol 23 (6): 463, 2005.

Unger JM, Thompson IM Jr, LeBlanc M, et al.: Estimated impact of the Prostate Cancer Prevention Trial on population mortality. Cancer 103 (7): 1375-80, 2005.[PUBMED Abstract]

Thompson IM, Tangen C, Goodman P: The Prostate Cancer Prevention Trial: design, status, and promise. World J Urol 21 (1): 28-30, 2003.[PUBMED Abstract]

Chung TD, Park II, Ignacio L, et al.: Television and news print media are effective in recruiting potential participants in a prostate cancer chemoprevention trial. Int J Cancer 90 (5): 302-4, 2000.[PUBMED Abstract]

Moinpour CM, Atkinson JO, Thomas SM, et al.: Minority recruitment in the prostate cancer prevention trial. Ann Epidemiol 10 (8 Suppl): S85-91, 2000.[PUBMED Abstract]

Thompson IM, Coltman CA: Re: re: chemoprevention of urological cancer. J Urol 164 (4): 1321-2, 2000.[PUBMED Abstract]

Coltman CA: The effect of finasteride on the prostate gland in men with elevated serum prostate-specific antigen level. Br J Cancer 81 (1): 184-5, 1999.[PUBMED Abstract]

Allerton J, Seay T, Optenberg S, et al.: Army and Air Force leadership in the Prostate Cancer Prevention Trial. Urology 51 (4A Suppl): 64-6, 1998.[PUBMED Abstract]

Ryan AM, Emel L, Goodman P: Data operations management and clinical datafax: the prostate cancer prevention trial (PCPT) experience. [Abstract] Control Clin Trials 18 (3 suppl): A- P74, 156S, 1997.

Thompson IM, Coltman CA: Screening for prostate cancer: opportunities for prevention. Semin Urol Oncol 14 (2 Suppl 2): 4-10; discussion 10-1, 1996.[PUBMED Abstract]

Feigl P, Blumenstein B, Thompson I, et al.: Design of the Prostate Cancer Prevention Trial (PCPT). Control Clin Trials 16 (3): 150-63, 1995.[PUBMED Abstract]

Thompson I, Feigl P, Coltman C: Chemoprevention of prostate cancer with finasteride. Important Adv Oncol : 57-76, 1995.[PUBMED Abstract]

Greco KE, Kulawiak L: Prostate cancer prevention: risk reduction through life-style, diet, and chemoprevention. Oncol Nurs Forum 21 (9): 1504-11, 1994.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Ian Thompson, MD, Protocol chair		Ph: 210-567-5643 Email: thompsoni@uthscsa.edu