Individual Study / PCPT

Prostate Cancer Prevention Trial
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Prostate Cancer Prevention Trial

Initiatives -
Start Year
1993
End Year
2009
Funding
The PCPT was funded by the National Cancer Institute (NCI), which gave $73 million in grants to the Southwest Oncology Group (SWOG). In addition, Merck and Co., of Whitehouse Station, N.J., the manufacturer of finasteride, provided both the finasteride and the placebo without charge, and paid for distributing the pills to the study sites.
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Investigators Contacts
  • Dr. Ian Thompson
    The University of Texas Health Science Center

Design

Study design
Clinical trial cohort
Follow Up
During the trial, men were followed semi-annually by means of study-site visits and telephone calls at each intervening 3-month and 9-month interval. The men underwent annual digital rectal examination and measurement of PSA. At the end of 7 years, all the men in whom prostate cancer had not been diagnosed were offered an end-of-study biopsy. Data collection and prostate-cancer assessments continued until June 2004, providing up to 10 years of continuous observation for the majority of the study participants. In 2005, 2 years after the publication of the primary report, we initiated a long-term follow-up study that finished in 2009. The follow-up study involved men in whom prostate cancer had been diagnosed during the study, with the objectives of estimating the time to metastases and the difference in all-cause and prostate-cancer mortality among men in the finasteride group, as compared with those in the placebo group.

Marker Paper

Feigl P, Blumenstein B, Thompson I, Crowley J, Wolf M, Kramer BS, Coltman CA Jr, Brawley OW, Ford LG. Design of the Prostate Cancer Prevention Trial (PCPT). Control Clin Trials. 1995 Jun;16(3):150-63. doi: 10.1016/0197-2456(94)00xxx-m.

PUBMED 7540965

Recruitment

Sources of Recruitment
  • Individuals

Number of participants

Number of participants
18,882
Number of participants with biosamples
Supplementary Information
Men 55 years of age and older who were in good health and who showed no evidence of prostate cancer could enroll in the trial

Access

Availability of data and biosamples

Data
Biosamples
Other
Yes
No
Not applicable
Don't know