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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
|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|
- This study is designed to address absolute incidence of erectile dysfunction, as measured by the International index of Erectile function.
- 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.
|Study Start Date:||March 2000|
|Estimated Study Completion Date:||April 2004|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242138
|University Health Network Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Padraig Warde, MD||Princess Margaret Hospital, Canada|