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Trial record 8 of 1110 for:    prostate cancer AND radiation

The Herlev Hospital Post Radiation Therapy for Localized Prostate Cancer Database for Sexual Side Effects

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ClinicalTrials.gov Identifier: NCT02274350
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : February 19, 2016
Sponsor:
Information provided by (Responsible Party):
Anders Frey, Herlev Hospital

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

Condition or disease Intervention/treatment
Cancer of the Prostate Radiation: radiation therapy

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 515 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Herlev Hospital Post Radiation Therapy for Localized Prostate Cancer Database for Sexual Side Effects
Study Start Date : May 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
radiation therapy
Patients treated with either external beam radiation therapy or brachie therapy for localized prostate cancer
Radiation: radiation therapy
Radiation therapy either in the form of external beam radiation or radioactive gold seeds planted directly in the prostate.



Primary Outcome Measures :
  1. Urinary incontinence during sexual activity [ Time Frame: between 3 months to 5 years after intervention ]
    prevalence rate

  2. penis shortening [ Time Frame: between 3 months to 5 years after intervention ]
    prevalence rate

  3. Orgasmic dysfunction [ Time Frame: between 3 months to 5 years after intervention ]
    prevalence rate

  4. anejaculation [ Time Frame: between 3 months to 5 years after intervention ]
    prevalence rate

  5. sensory changes in the penis [ Time Frame: between 3 months to 5 years after intervention ]
    prevalence rate


Secondary Outcome Measures :
  1. erectile functioning [ Time Frame: between 3 months to 5 years after intervention ]
    intenational index of erectile function score

  2. Urinary incontinence [ Time Frame: between 3 months to 5 years after intervention ]
    international consultation of incontinence questionnaire

  3. comorbidities [ Time Frame: between 3 months to 5 years after intervention ]
    charlston comorbidity index

  4. gastro intestinal side effects [ Time Frame: between 3 months to 5 years after intervention ]
    prevalence rate



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274350


Sponsors and Collaborators
Herlev Hospital
Investigators
Study Chair: Jens Sønksen, Professor The unit for urological research, Herlev Hospital

Publications:

Responsible Party: Anders Frey, research assistant, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02274350     History of Changes
Other Study ID Numbers: HEH-2014-091
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016

Keywords provided by Anders Frey, Herlev Hospital:
prostate cancer
radiation therapy
sexual side effects

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases