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
Status | Completed |
Enrollment | 515 |
Est. completion date | November 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Herlev Hospital |
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. — View Citation
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. — View Citation
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. Review. — View Citation
Frey A, Sønksen 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. — View Citation
Frey AU, Sønksen 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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urinary incontinence during sexual activity | prevalence rate | between 3 months to 5 years after intervention | No |
Primary | penis shortening | prevalence rate | between 3 months to 5 years after intervention | No |
Primary | Orgasmic dysfunction | prevalence rate | between 3 months to 5 years after intervention | No |
Primary | anejaculation | prevalence rate | between 3 months to 5 years after intervention | No |
Primary | sensory changes in the penis | prevalence rate | between 3 months to 5 years after intervention | No |
Secondary | erectile functioning | intenational index of erectile function score | between 3 months to 5 years after intervention | No |
Secondary | Urinary incontinence | international consultation of incontinence questionnaire | between 3 months to 5 years after intervention | No |
Secondary | comorbidities | charlston comorbidity index | between 3 months to 5 years after intervention | No |
Secondary | gastro intestinal side effects | prevalence rate | between 3 months to 5 years after intervention | No |
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