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Erectile Dysfunction/Prostate/RT/Androgen

NCT00242138 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-02-09

No results posted yet for this study

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.

Conditions

  • Prostatic Neoplasms

Interventions

BEHAVIORAL

Erectile Dysfunction

Sponsors & Collaborators

  • Princess Margaret Hospital, Canada

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Padraig Warde, MD · Princess Margaret Hospital, Canada

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-03-31
Completion
2004-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00242138 on ClinicalTrials.gov