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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

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Detailed Description:

Aim:

According to the European Association of Urology guidelines radical prostatectomy (RP) and external beam radiation therapy (EBRT) are considered equal treatments with curative intends, for localized prostate cancer [1]. Another type of radiation therapy used to treat localized prostate cancer is brachytherapy (BT). After both RP and EBRT some patients suffer a degree of erectile dysfunction (ED) and urinary incontinence (UI) [2-5]. However, current evidence shows that rates are lower with EBRT [4,5]. Unfortunately, EBRT hold the potential for late-onset toxicity and can, in a small percentage of the patients, lead to secondary genitourinary or gastrointestinal cancers [5]. In a recent study of RP patients at Herlev hospital, the investigators found that many patients, in addition to ED and UI, also suffered from UI during sexual activity, Orgasmic dysfunction, and penile morphological and sensory changes [6]. Only few studies have investigated these side effects in EBRT and BT patients.

The aim for this study is therefore:

  • To investigate which sexual side effects occur after EBRT and BT
  • 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

Background:

As mentioned above, very few studies have investigated sexual side effects aside from ED in EBRT patients. O'Neil et al found that out of 110 EBRT patients 5.2% reported to have orgasm associated UI; while, 28.3% of the 279 RP patients queried reported the problem [7]. Penile shortening have has consistently been found after RP [8]. However, after both brachytherapy and ERBT in conjunction with androgen deprivation therapy penile shortening have has also been described [9] . Sullivan et al. investigated ejaculatory profiles en men undergoing radiation therapy (RT), either EBRT, brachytherapy, or a combination of both [10]. They found that 5 years after RT 89% of the patients reported anejaculation. During the 5 years of follow up patients reported increasingly bad scores, as measured by the orgasm domain of the international index of erectile function (IIEF).

Research plan, participants, and methods:

Because of the apparent shortage of studies with the main aim of investigating sexual side effects other than ED after EBRT and BT, the investigators want conduct a single center cross-sectional questionnaire based study which will be comparable to our study on RP side effects [6]. The investigators hope to document how many patients are affected by UI during sexual stimulation, altered perception of orgasm, anejaculation, orgasm-associated pain, penile shortening, altered penile curvature, and penile sensory changes. Furthermore we want to identify predicting and associated factors to better understand why and when these side effects occur.

The study will start in September 2014 and the investigators anticipate to have completed data collection in December 2014. Initially the investigators plan to invite 20 patients to participate in interview sessions where they will be given the opportunity to contribute to the design of the questionnaire. When the final questionnaire is ready all suited patients will receive the questionnaire by mail. Initial non-responders will receive another questionnaire 4-6 weeks later in order to get as many answers as possible. In order to grant us permission to search the patients´ journals for background information all patients will receive an informed consent formula to sign.

Recruiting of patient and informed consent:

Patients will be identified through hospital records. Initially 10 EBRT patients and 10 BT patients will be contacted by telephone in order to arrange the interview sessions. The remaining patients will only be contacted by mail as described above. Patients will be informed of the purpose of the study and that the final publication of study result will be kept anonymous. Patients will be asked to state that they accept the publication.

The initial questionnaires will be accompanied by a letter explaining the importance of participating. One month after the questionnaires are expected to have been received by the patients a reminder will be send to non-responders.

Publication of results:

The final results will be published in a peer reviewed international journal as soon as possible. Should that not be possible the results will be made public on our hospitals internet homepage. Prevalence rates will be the main outcomes; while Univariate and multivariate logistic regression analyses will be used for the purpose of identifying associated and predicting factors.

Ethics:

The study will be carried out according to the rules stated in the declaration of Helsinki and Danish law concerning health care research. The study is approved by the Danish data protection agency and registered at clinicaltrials.org.

Hopefully this study can help adding valuable knowledge to an area that is largely undiscovered. In addition, the investigators expect these results to help draw a clearer picture of the pros and cons of RP, BT, and EBRT as treatments for localized prostate cancer. Finally, this study should help patients suffering sexual side effects after EBRT by making practitioners aware of their existence and providing them with knowledge to better inform future patients.


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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


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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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
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Study Chair: Jens Sønksen, Professor The unit for urological research, Herlev Hospital

Publications:

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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:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases