Cancer of the Prostate Clinical Trial
Official title:
The Herlev Hospital Post Radiation Therapy for Localized Prostate Cancer Database for Sexual Side Effects
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
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.
;
Observational Model: Cohort, Time Perspective: Cross-Sectional
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