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Erectile DysfunctionEDtoPCNCT03009123

Will Erectile Dysfunction Increase the Risk of Prostate Cancer

An observational study of Erectile Dysfunction, run by Kuang Tien General Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 50 to 99 years, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
Erectile dysfunction
How many people
21,558 participants
Where
1 siteTaiwan
Study dates
Jan 2016to 6 May 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 99 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kuang Tien General Hospital

    Taichung, 43303

Other trials in Taiwan

About this study

Official title: 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.

Being tested
Erectile dysfunction
Keywords
cohort study, prostate cancer, population-based study, benign prostatic hypertrophy
Medical subject headings
Erectile Dysfunction, Prostatic Neoplasms, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erectile dysfunctionOther

    Patients with ED are considered belonging to the exposure group.

Study groups in NCT03009123
Study groupRoleWhat they receive
Erectile dysfunction groupGroup contains men with physician-diagnosed erectile dysfunction
Receives: Other: Erectile dysfunction
General population men without EDMen 50 years and older having no ED and pre-existing prostate cancer
Symptomatic BPH group without EDMen 50 years old older with symptomatic prostatic hypertrophy but with no ED nor pre-existing prostate cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incident prostate cancer

    Measured: through study completion, up to 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2017 (estimated)
  2. Study startJan 2016
  3. Primary completion15 Mar 2017
  4. Study completion6 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
21,558 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03009123
Sponsor's protocol ID
KTGH-ASIAU-obs-erectile
Acronym
EDtoPC
Status last verified
May 2017
First submitted
28 Dec 2016
Last updated
9 May 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Sairam K, Kulinskaya E, Boustead GB, Hanbury DC, McNicholas TA. Prevalence of undiagnosed prostate cancer in men with erectile dysfunction. BJU Int. 2002 Feb;89(3):261-3. doi: 10.1046/j.1464-4096.2001.01271.x.

    PubMed 11856107

  • Saitz TR, Serefoglu EC, Trost LW, Thomas R, Hellstrom WJ. The pre-treatment prevalence and types of sexual dysfunction among patients diagnosed with prostate cancer. Andrology. 2013 Nov;1(6):859-63. doi: 10.1111/j.2047-2927.2013.00137.x. Epub 2013 Oct 11.

    PubMed 24127273

  • Resnick MJ, Barocas DA, Morgans AK, Phillips SE, Chen VW, Cooperberg MR, Goodman M, Greenfield S, Hamilton AS, Hoffman KE, Kaplan SH, Paddock LE, Stroup AM, Wu XC, Koyama T, Penson DF. Contemporary prevalence of pretreatment urinary, sexual, hormonal, and bowel dysfunction: Defining the population at risk for harms of prostate cancer treatment. Cancer. 2014 Apr 15;120(8):1263-71. doi: 10.1002/cncr.28563. Epub 2014 Feb 7.

    PubMed 24510400

  • Chou PS, Chou WP, Chen MC, Lai CL, Wen YC, Yeh KC, Chang WP, Chou YH. Newly diagnosed erectile dysfunction and risk of depression: a population-based 5-year follow-up study in Taiwan. J Sex Med. 2015 Mar;12(3):804-12. doi: 10.1111/jsm.12792. Epub 2014 Dec 5.

    PubMed 25475605

  • Lee PH, Kok VC, Chou PL, Ku MC, Chen YC, Horng JT. Risk and clinical predictors of osteoporotic fracture in East Asian patients with chronic obstructive pulmonary disease: a population-based cohort study. PeerJ. 2016 Oct 27;4:e2634. doi: 10.7717/peerj.2634. eCollection 2016.

    PubMed 27812429

  • Kok VC, Horng JT, Hung GD, Xu JL, Hung TW, Chen YC, Chen CL. Risk of Autoimmune Disease in Adults with Chronic Insomnia Requiring Sleep-Inducing Pills: A Population-Based Longitudinal Study. J Gen Intern Med. 2016 Sep;31(9):1019-26. doi: 10.1007/s11606-016-3717-z. Epub 2016 Apr 29.

    PubMed 27130621

  • Kok VC, Sung FC, Kao CH, Lin CC, Tseng CH. Cancer risk in East Asian patients associated with acquired haemolytic anaemia: a nationwide population-based cohort study. BMC Cancer. 2016 Feb 4;16:57. doi: 10.1186/s12885-016-2098-3.

    PubMed 26846920

  • Kok VC, Tsai HJ, Su CF, Lee CK. The Risks for Ovarian, Endometrial, Breast, Colorectal, and Other Cancers in Women With Newly Diagnosed Endometriosis or Adenomyosis: A Population-Based Study. Int J Gynecol Cancer. 2015 Jul;25(6):968-76. doi: 10.1097/IGC.0000000000000454.

    PubMed 25893280

  • Kok VC, Horng JT, Huang HK, Chao TM, Hong YF. Regular inhaled corticosteroids in adult-onset asthma and the risk for future cancer: a population-based cohort study with proper person-time analysis. Ther Clin Risk Manag. 2015 Mar 26;11:489-99. doi: 10.2147/TCRM.S80793. eCollection 2015.

    PubMed 25848295

  • Kok VC, Horng JT, Huang JL, Yeh KW, Gau JJ, Chang CW, Zhuang LZ. Population-based cohort study on the risk of malignancy in East Asian children with juvenile idiopathic arthritis. BMC Cancer. 2014 Aug 29;14:634. doi: 10.1186/1471-2407-14-634.

    PubMed 25174953

  • Kok VC, Horng JT, Chang WS, Hong YF, Chang TH. Allopurinol therapy in gout patients does not associate with beneficial cardiovascular outcomes: a population-based matched-cohort study. PLoS One. 2014 Jun 4;9(6):e99102. doi: 10.1371/journal.pone.0099102. eCollection 2014.

    PubMed 24897240

  • Kok VC, Horng JT, Lin HL, Chen YC, Chen YJ, Cheng KF. Gout and subsequent increased risk of cardiovascular mortality in non-diabetics aged 50 and above: a population-based cohort study in Taiwan. BMC Cardiovasc Disord. 2012 Nov 21;12:108. doi: 10.1186/1471-2261-12-108.

    PubMed 23170782

Questions about this trial

What is this clinical trial studying?

An observational study of Erectile Dysfunction, run by Kuang Tien General Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incident prostate cancer (time frame: through study completion, up to 7 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03009123, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.

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