PCPT Long Term Follow-Up Study
The Southwest Oncology Group, with the support of the National Cancer Institute, has opened a study for men who participated in the PCPT and were diagnosed with prostate cancer during the course of the trial. The PCPT researchers need information about the prostate cancers that occurred in men who took finasteride and from men who were on the placebo. By comparing the cancers in these two groups of men, the researchers may be able to see if there is a difference in the behavior of their tumors that could shed additional light on the results of the study.
The PCPT Long Term Follow-up study will allow investigators to keep in contact with their men diagnosed with prostate cancer to collect extra information about their health over time. Men who enroll in this study will be contacted every six months, probably by telephone, to provide updates on their general health and prostate cancer status. There are no required clinic visits and no required tests or physical exams in the PCPT Long Term Follow-Up study. No study drug will be issued.
If you participated in PCPT and are interested in joining the Long Term Follow-up study, contact your PCPT study site. If that site is no longer open, please contact Susie Carlin (206-667-6868) at the PCPT Statistical Center to obtain the contact information for participating study sites.
Since the publication of the results in 2003, researchers have continued to review and analyze the data obtained from the men who participated on the trial. Their reviews have led to additional study publications. Click on the links below to read the summaries of these recent publications:
In February 2005, a follow-up analysis of data from PCPT, published online in the journal Cancer, showed that if finasteride were prescribed as a preventive therapy to older men, an estimated 316,760 years of life would be saved over 10 years through the prevention of prostate cancer.
The Original PCPT Study
The PCPT began enrolling men in the study on October 13, 1993. The study ended on May 16, 1997 after 18,882 had been randomized to the study. The men were randomly assigned to take either 5 milligrams of finasteride or a placebo on a daily basis for seven years. The researchers contacted the men two to four times per year for an update on their general health. The men were asked to have a digital rectal exam (DRE) and prostate-specific antigen (PSA) blood test annually. At the end of seven years, men who were medically able and willing were asked to have a needle biopsy of the prostate performed to check for prostate cancer. These end-of-study prostate biopsies began in October 2000.
The analysis of PCPT study data revealed that men in the finasteride group who were evaluated were 24.8% less likely to develop prostate cancer when compared to the men evaluated who were in the placebo group (18.4% of men on finasteride versus 24.4% of men on placebo developed prostate cancer).
The study data also suggest a note of caution. Although the men taking finasteride had fewer prostate cancers, they had an increased number of high-grade prostate cancers (Gleason 7-10) which can spread quickly even if the tumor is small. In the entire group of men assigned to finasteride who were evaluated, 6.4% had high-grade cancers while 5.1% of men evaluated in the placebo group had high-grade cancers. Almost all of the prostate cancers diagnosed during the study were found in an early stage, when they are very treatable. One of the objectives of the PCPT Long Term Follow-up study, discussed above, is to better determine whether finasteride causes more aggressive tumors to develop or whether finasteride affects the appearance of prostate cancers under the microscope leading to a faulty estimate of tumor grade.
Letters announcing study closure and initial findings were mailed out to the men who participated in this study. If you were a participant in the study and you did not receive a study closure notification letter, please contact the clinic or hospital where you participated in the PCPT, or you may contact 1-800-4CANCER (1-800-422-6237) for more information.
PCPT Science Continues: Program Project Grant
Five Southwest Oncology Group Prostate Cancer Prevention Trial ancillary studies were funded in spring 2005 through a program project (P01) grant. The project involves investigators throughout North America.
The overall goal of the program is to understand the biologic mechanisms underlying the results of the PCPT. These ancillary studies will analyze the prostate tissue, blood and white cell samples collected during PCPT. The unifying theme is the genetic, metabolic and environmental factors associated with the risks of prostate cancer and high-grade prostate cancer, as well as the effects of these factors on how effective finasteride is in preventing prostate cancer.
One unusual aspect of this program project grant is that the highly integrated cores and projects will be led by investigators from different research institutions. The three core management areas of the study, however, will reside in established PCPT/Southwest Oncology Group facilities.
- The Administrative Core, led by the program project's Principal Investigator Scott M. Lippman, M.D., will be managed jointly by M.D. Anderson and the Southwest Oncology Group Operations Office.
- The Biostatistics/Data Management Core will be led by Cathy Tangen, Dr.P.H., at the Group's Statistical Center in Seattle.
- The Pathology/Genotyping Core will be led by M. Scott Lucia, M.D., at the University of Colorado.
The Five Studies
The five ancillary studies, their principal investigators and their institutions include:
- Androgen metabolism, Juergen Reichart, Ph.D., University of Southern California Keck School of Medicine.
- Insulin-like growth factor axis and insulin resistance, Michael Pollock, M.D., McGill University, Montreal, Quebec, Canada.
- Diet and diet-related factors, Alan R. Kristal, Dr.P.H., Fred Hutchinson Cancer Research Center, Seattle, Wash.
- Oxidative damage and DNA repair, Regina M. Santella, Ph.D., Columbia University, New York, N.Y.
- Genotypic and phenotypic studies of inflammation, Elizabeth A. Platz, Sc.D., M.P.H., Johns Hopkins Bloomberg School of Public Health, Baltimore, Md.
The grant application was initially submitted in October 2003 and was approved for funding in February 2005.
PCPT Biorepository User Guide
This guide outlines the procedures for investigators to request use of any biospecimens collected in the Prostate Cancer Prevention Trial. Its purpose is to facilitate the conduct of high-quality, hypothesis-driven research in an efficient, coordinated, and equitable manner.
The Prostate Cancer Prevention Trial was funded by the National Cancer Institute. For additional information about the study visit the PCPT Page on the NCI website.
For more information about Southwest Oncology Group, click the appropriate link on the left.