Will Erectile Dysfunction Increase the Risk of Prostate Cancer (EDtoPC)

May 8, 2017 updated by: Victor C. Kok, MMedSc, MD, PhD, FACP, Kuang Tien General Hospital

Erectile Dysfunction and the Future Risk of Prostate Cancer: a Population-based Longitudinal Follow-up Study With Concurrent Double Comparison Cohorts

The rationale for investigating the hypothesis that there is an association between erectile dysfunction (ED) and the subsequent development of prostate cancer is based on three assumptions: 1) baseline ED is common in most if not all of the cross-sectional studies in men with prostate cancer; 2) the development of ED and prostate cancer may have certain shared common risk factors; and 3) the use of testosterone for the treatment of ED has been suspected to be associated with prostate cancer development. Controversy exists over whether men with ED have an increased risk of subsequent prostate cancer. Few studies have evaluated the risk of developing prostate cancer for men with ED. The investigators, therefore, conducted a population-based longitudinal study with eight years' follow-up to examine this association and to evaluate the magnitude of the risk.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

21558

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 43303
        • Kuang Tien General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

The study cohort was constructed from the Taiwan National Health Insurance Research Dataset. From among men with no pre-existing prostate cancer, we formed an ED group of men ≥50 years of age and a non-ED general population comparison group of men matched 1:4 by age and index date of the ED group and a concurrent second comparison group of men older than 50 with benign prostatic hypertrophy.

Description

Inclusion Criteria:

  • men 50 years and older with no pre-existing prostate cancer

Exclusion Criteria:

  • less than 50 years old
  • pre-existing prostate cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Erectile dysfunction group
Group contains men with physician-diagnosed erectile dysfunction
Other: Erectile dysfunction
Patients with ED are considered belonging to the exposure group.
General population men without ED
Men 50 years and older having no ED and pre-existing prostate cancer
Symptomatic BPH group without ED
Men 50 years old older with symptomatic prostatic hypertrophy but with no ED nor pre-existing prostate cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incident prostate cancer
Time Frame: through study completion, up to 7 years
through study completion, up to 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuang Tien General Hospital

Collaborators

National Central University, Taiwan
Asia University

Investigators

  • Study Director: Victor C Kok, MD, PhD, Disease Informatics Research Unit, Asia University Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

March 15, 2017

Study Completion (Actual)

May 6, 2017

Study Registration Dates

First Submitted

December 28, 2016

First Submitted That Met QC Criteria

December 30, 2016

First Posted (Estimate)

January 4, 2017

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KTGH-ASIAU-obs-erectile

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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