Clinical trial · Observational

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

NCT02274350CI-TRIAL-00020987completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cancer of the Prostate	Malignant Prostate Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
radiation therapy	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
radiation therapy
description
Patients treated with either external beam radiation therapy or brachie therapy for localized prostate cancer
interventionNames
1. Radiation: radiation therapy

Primary outcomes (5)

measure
Urinary incontinence during sexual activity
timeFrame
between 3 months to 5 years after intervention
description
prevalence rate
measure
penis shortening
timeFrame
between 3 months to 5 years after intervention
description
prevalence rate
measure

Eligibility

Eligibility (as posted)

Sex: Male

Show eligibility criteria text

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

References

Publications (10)

BACKGROUNDHeidenreich 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 24207135
BACKGROUNDTal 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 19515209
BACKGROUNDFicarra 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 22749852
BACKGROUNDRobinson 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 12419432
BACKGROUNDAtaman 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 15251156
BACKGROUNDO'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 24050893