- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03009123
Will Erectile Dysfunction Increase the Risk of Prostate Cancer (EDtoPC)
8 maj 2017 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Faktisk)
21558
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Taichung, Taiwan, 43303
- Kuang Tien General Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
50 år till 99 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Manlig
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
Inclusion Criteria:
- men 50 years and older with no pre-existing prostate cancer
Exclusion Criteria:
- less than 50 years old
- pre-existing prostate cancer
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Erectile dysfunction group
Group contains men with physician-diagnosed 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Incident prostate cancer
Tidsram: through study completion, up to 7 years
|
through study completion, up to 7 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Victor C Kok, MD, PhD, Disease Informatics Research Unit, Asia University Taiwan
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2016
Primärt slutförande (Faktisk)
15 mars 2017
Avslutad studie (Faktisk)
6 maj 2017
Studieregistreringsdatum
Först inskickad
28 december 2016
Först inskickad som uppfyllde QC-kriterierna
30 december 2016
Första postat (Uppskatta)
4 januari 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 maj 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 maj 2017
Senast verifierad
1 maj 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KTGH-ASIAU-obs-erectile
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Erektil dysfunktion
-
Consorcio Centro de Investigación Biomédica en...Hospital General Universitario Gregorio Marañon; Universidad Complutense... och andra samarbetspartnersHar inte rekryterat ännuLeverfibros/NASH | MASH - Metabolic Dysfunction-Associated Steatohepatitis | MASLD - Metabolic Dysfunction-Associated Steatotic Lever DiseaseSpanien
-
Rivus Pharmaceuticals, Inc.RekryteringMASH - Metabolic Dysfunction-Associated SteatohepatitisFörenta staterna
-
Qilu Pharmaceutical Co., Ltd.Har inte rekryterat ännuMetabolic Dysfunction-Associated Steatohepatitis (MASH)
-
Madrigal Pharmaceuticals, Inc.RekryteringMASH - Metabolic Dysfunction-Associated SteatohepatitisFörenta staterna
-
Shanghai East HospitalRekryteringMASH - Metabolic Dysfunction-Associated SteatohepatitisKina
-
Southern California Institute for Research and...Har inte rekryterat ännuMASH - Metabolic Dysfunction-Associated Steatohepatitis
-
Nabiqasim Industries (Pvt) LtdRekryteringMASH - Metabolic Dysfunction-Associated SteatohepatitisPakistan
-
Fondazione Policlinico Universitario Agostino Gemelli...RekryteringMASLD - Metabolic Dysfunction-Associated Steatotic Lever DiseaseItalien
-
Tangram Therapeutics PlcRekryteringFriska deltagare | MASH - Metabolic Dysfunction-Associated SteatohepatitisStorbritannien
-
University of Campania Luigi VanvitelliAvslutadMASLD - Metabolic Dysfunction-Associated Steatotic Lever DiseaseItalien