EARLY DETECTION RESEARCH GROUP

Key Programs

International Prostate Screening Trials Evaluation Group (IPSTEG)

Background Information

The International Prostate Screening Trial Evaluation Group (IPSTEG) is a collaboration between the researchers in Europe and North America conducting prostate cancer screening randomized trials. Countries included in the collaboration are Belgium, Finland, Italy, Portugal, Spain, Sweden, Switzerland, the Netherlands and the United States.

The purpose of this collaboration is to develop and implement an evaluation plan for the joint analysis of randomized trial data on prostate cancer screening using prostate specific antigen (PSA). A combined analysis offers increased statistical power and a larger, more informative database over an individual study. The total sample is anticipated to be in excess of 300,000 men, with a follow-up period of at least 10 years.

Common Areas and Variabilities

All trials adhere to a common core protocol with mortality from prostate cancer as the primary endpoint. Some core elements are age at recruitment between 55 and 67, collection of baseline characteristics, exclusion of men with previous diagnosis of prostate cancer, individual randomization, information on contamination levels, and evaluation of cost effectiveness.

Although the trials have a common core protocol, variability exists among the trials which will allow for important comparisons beyond the protocol of any one trial. Some of these elements are variability in PSA cut points, PSA screening with and without digital rectal examination (DRE), different screening intervals (from one to four years), and inclusion of men outside the core ages. This variability will allow examination of sensitivity and specificity at various PSA cut-offs, differences between screening frequencies and optimal age for beginning and ending screening.

Information Exchange

The IPSTEG collaboration has resulted in a rich exchange of information. IPSTEG meets annually in conjunction with the European Randomized Study of Screening for Prostate Cancer (ERSPC) to monitor the adherence of individual trials to the core protocol. In addition to developing an evaluation plan, the group is also devising a publication policy and protocols for pathology and death review. Individual trials within IPSTEG are collecting and sharing information on health related quality of life and cost effectiveness in relation to prostate cancer screening.

	EARLY DETECTION RESEARCH GROUP Key Programs International Prostate Screening Trials Evaluation Group (IPSTEG) Background Information The International Prostate Screening Trial Evaluation Group (IPSTEG) is a collaboration between the researchers in Europe and North America conducting prostate cancer screening randomized trials. Countries included in the collaboration are Belgium, Finland, Italy, Portugal, Spain, Sweden, Switzerland, the Netherlands and the United States. The purpose of this collaboration is to develop and implement an evaluation plan for the joint analysis of randomized trial data on prostate cancer screening using prostate specific antigen (PSA). A combined analysis offers increased statistical power and a larger, more informative database over an individual study. The total sample is anticipated to be in excess of 300,000 men, with a follow-up period of at least 10 years. Common Areas and Variabilities All trials adhere to a common core protocol with mortality from prostate cancer as the primary endpoint. Some core elements are age at recruitment between 55 and 67, collection of baseline characteristics, exclusion of men with previous diagnosis of prostate cancer, individual randomization, information on contamination levels, and evaluation of cost effectiveness. Although the trials have a common core protocol, variability exists among the trials which will allow for important comparisons beyond the protocol of any one trial. Some of these elements are variability in PSA cut points, PSA screening with and without digital rectal examination (DRE), different screening intervals (from one to four years), and inclusion of men outside the core ages. This variability will allow examination of sensitivity and specificity at various PSA cut-offs, differences between screening frequencies and optimal age for beginning and ending screening. Information Exchange The IPSTEG collaboration has resulted in a rich exchange of information. IPSTEG meets annually in conjunction with the European Randomized Study of Screening for Prostate Cancer (ERSPC) to monitor the adherence of individual trials to the core protocol. In addition to developing an evaluation plan, the group is also devising a publication policy and protocols for pathology and death review. Individual trials within IPSTEG are collecting and sharing information on health related quality of life and cost effectiveness in relation to prostate cancer screening.



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