NCT02274350

Brief Summary

The aim of this study is:

  • To investigate which sexual side effects occur after external beam radiation therapy and brachie therapy
  • To investigate how many patients are affected
  • To investigate if there is a time dependency for the severity of the sexual side effects
  • To investigate if there is a dose dependency for the severity of the sexual side effects
  • To find predicting and associated factors for the discovered sexual side effects to help identifying patients at risk

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
515

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

5 months

First QC Date

October 20, 2014

Last Update Submit

February 17, 2016

Conditions

Cancer of the Prostate

Keywords

prostate cancerradiation therapysexual side effects

Outcome Measures

Primary Outcomes (5)

  • Urinary incontinence during sexual activity

    prevalence rate

    between 3 months to 5 years after intervention

  • penis shortening

    prevalence rate

    between 3 months to 5 years after intervention

  • Orgasmic dysfunction

    prevalence rate

    between 3 months to 5 years after intervention

  • anejaculation

    prevalence rate

    between 3 months to 5 years after intervention

  • sensory changes in the penis

    prevalence rate

    between 3 months to 5 years after intervention

Secondary Outcomes (4)

  • erectile functioning

    between 3 months to 5 years after intervention

  • Urinary incontinence

    between 3 months to 5 years after intervention

  • comorbidities

    between 3 months to 5 years after intervention

  • gastro intestinal side effects

    between 3 months to 5 years after intervention

Study Arms (1)

radiation therapy

Patients treated with either external beam radiation therapy or brachie therapy for localized prostate cancer

Radiation: radiation therapy

Interventions

radiation therapyRADIATION

Radiation therapy either in the form of external beam radiation or radioactive gold seeds planted directly in the prostate.

radiation therapy

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients have received either external beam radiation therapy or brachie therapy as definitive treatment for localized prostate cancer between at Herlev hospital, Copenhagen, Denmark between 3 months and 5 years prior to being invited to participate in the study.

You may qualify if:

  • All patients must have received EBRT or BT with curative intent for localized prostate cancer.
  • Only patients who have received EBRT or BT between 3 months and 5 years prior the start of the study will be enrolled.

You may not qualify if:

  • Patients who had symptoms corresponding to the abovementioned side effects before EBRT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Heidenreich A, Bastian PJ, Bellmunt J, Bolla M, Joniau S, van der Kwast T, Mason M, Matveev V, Wiegel T, Zattoni F, Mottet N; European Association of Urology. EAU guidelines on prostate cancer. part 1: screening, diagnosis, and local treatment with curative intent-update 2013. Eur Urol. 2014 Jan;65(1):124-37. doi: 10.1016/j.eururo.2013.09.046. Epub 2013 Oct 6.

    PMID: 24207135BACKGROUND

  • Tal R, Alphs HH, Krebs P, Nelson CJ, Mulhall JP. Erectile function recovery rate after radical prostatectomy: a meta-analysis. J Sex Med. 2009 Sep;6(9):2538-46. doi: 10.1111/j.1743-6109.2009.01351.x. Epub 2009 Jun 9.

    PMID: 19515209BACKGROUND

  • Ficarra V, Novara G, Rosen RC, Artibani W, Carroll PR, Costello A, Menon M, Montorsi F, Patel VR, Stolzenburg JU, Van der Poel H, Wilson TG, Zattoni F, Mottrie A. Systematic review and meta-analysis of studies reporting urinary continence recovery after robot-assisted radical prostatectomy. Eur Urol. 2012 Sep;62(3):405-17. doi: 10.1016/j.eururo.2012.05.045. Epub 2012 Jun 1.

    PMID: 22749852BACKGROUND

  • Robinson JW, Moritz S, Fung T. Meta-analysis of rates of erectile function after treatment of localized prostate carcinoma. Int J Radiat Oncol Biol Phys. 2002 Nov 15;54(4):1063-8. doi: 10.1016/s0360-3016(02)03030-4.

    PMID: 12419432BACKGROUND

  • Ataman F, Zurlo A, Artignan X, van Tienhoven G, Blank LE, Warde P, Dubois JB, Jeanneret W, Keuppens F, Bernier J, Kuten A, Collette L, Pierart M, Bolla M. Late toxicity following conventional radiotherapy for prostate cancer: analysis of the EORTC trial 22863. Eur J Cancer. 2004 Jul;40(11):1674-81. doi: 10.1016/j.ejca.2003.12.027.

    PMID: 15251156BACKGROUND

  • O'Neil BB, Presson A, Gannon J, Stephenson RA, Lowrance W, Dechet CB, Tward JD, Myers JB, Brant WO. Climacturia after definitive treatment of prostate cancer. J Urol. 2014 Jan;191(1):159-63. doi: 10.1016/j.juro.2013.06.122. Epub 2013 Sep 16.

    PMID: 24050893BACKGROUND

  • Frey A, Sonksen J, Jakobsen H, Fode M. Prevalence and predicting factors for commonly neglected sexual side effects to radical prostatectomies: results from a cross-sectional questionnaire-based study. J Sex Med. 2014 Sep;11(9):2318-26. doi: 10.1111/jsm.12624. Epub 2014 Jul 4.

    PMID: 24995845BACKGROUND

  • Frey AU, Sonksen J, Fode M. Neglected side effects after radical prostatectomy: a systematic review. J Sex Med. 2014 Feb;11(2):374-85. doi: 10.1111/jsm.12403. Epub 2013 Nov 25.

    PMID: 24267516BACKGROUND

  • Eylert MF, Bahl A, Persad R. Do we need to obtain consent for penile shortening as a complication of treatment for organ-confined prostate cancer? BJU Int. 2012 Nov;110(10):1491-500. doi: 10.1111/j.1464-410X.2012.11102.x. Epub 2012 Apr 23.

    PMID: 22520266BACKGROUND

  • Sullivan JF, Stember DS, Deveci S, Akin-Olugbade Y, Mulhall JP. Ejaculation profiles of men following radiation therapy for prostate cancer. J Sex Med. 2013 May;10(5):1410-6. doi: 10.1111/jsm.12101. Epub 2013 Feb 22.

    PMID: 23433425BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Jens Sønksen, Professor

    The unit for urological research, Herlev Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

October 20, 2014

First Posted

October 24, 2014

Study Start

May 1, 2015

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

February 19, 2016

Record last verified: 2016-02