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
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 |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 2004 |
Est. primary completion date | |
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. |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network Princess Margaret Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Princess Margaret Hospital, Canada |
Canada,
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. |
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