Erectile Dysfunction/Prostate/RT/Androgen

Prostatic Neoplasms Clinical Trial

Official title:

A Cross-Sectional Study of Erectile Dysfunction in Patients With Locally Advanced Prostate Cancer Who Have Undergone Radiotherapy and Prolonged Pharmacological Androgen Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242138
• Other study ID #: UHN REB 01-0552-C
• Status: Completed
• Phase: Phase 2
• First received: October 18, 2005
• Last updated: February 8, 2016
• Start date: March 2000
• Est. completion date: April 2004

Study information

• Verified date: February 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

• No patients who have been treated, or are currently being treated with Bicalutamide

• no previous orchidectomy.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Erectile Dysfunction
• Prostatic Neoplasms

Intervention

Behavioral:
• Erectile Dysfunction

Locations

Country	Name	City	State
Canada	University Health Network Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This study is designed to address absolute incidence of erectile dysfunction, as measured by the International index of Erectile function.
Secondary	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.