Erectile Dysfunction/Prostate/RT/Androgen

Phase 2

Completed

• Conditions: Prostatic Neoplasms

• Registration Number: NCT00242138
• Lead Sponsor: University Health Network, Toronto

Brief Summary

The optimal duration of hormonal therapy is yet to be determined in the treatment of locally advanced carcinoma of the prostate. The RTOG performed a trial of 4 months of neoadjuvant and concurrent hormones(consisting of Goserelin and Flutamide) compared to radiation alone, and found that there was an improvement in local control and progression-free survival, but no improvement in overall survival. The EORTC performed a similar trial, but used Goserelin alone for a period of 3 years. This trial showed an improvement in local control, disease-free survival, and in contrast to the RTOG trial, an improvement in overall survival.

The rate of erectile dysfunction in men who receive a prolonged period of Gosereline (i.e. 2 yrs) is not known, but suspected according to expert opinion, to be significantly higher than a shorter course of hormonal ablation. Therefore the price of of a survival advantage in locally advanced prostate cancer maybe at a cost of increased rates of erectile dysfunction.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-03
• Study Completion: 2004-04
• Study First Submitted: 2005-10-18
• Study First Submitted QC: 2005-10-18
• Study First Posted: 2005-10-19
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Patients with clinical stage T1-T4 carcinoma of the prostate
• Must have undergone radical radiation and at least 2 years of Pharmacological androgen ablation.Pharmacological androgen ablation may include: LHRH-agonists with or without Non-steroidal androgen ablation, Steroidal Anti-androgens, Progestational agents, and Cypoterone (Androcur).
• Must be currently 6 months or more after their last injection of LHRH-agonists if it was being given every 3 months or 4 months or more after their last injection, if it was being given monthly. If the patient was on oral androgen ablation agent, they must be off this medication for a period of at least 4 months.
• currently off hormonal therapy
• Able to sign the consent form and fill out questionnaire used in the study.

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Exclusion Criteria

• No patients who have been treated, or are currently being treated with Bicalutamide
• no previous orchidectomy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
This study is designed to address absolute incidence of erectile dysfunction, as measured by the International index of Erectile function.

Secondary Outcome Measures

Name	Time	Method
This study is designed to address the effects of erectile dysfunction persist one year after the initial assessment of erectile dysfunction,as measured by the International index of Erectile function.

Trial Locations

Locations (1)

University Health Network Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada