Erectile Dysfunction/Prostate/RT/Androgen

University Health Network, Toronto

Status and phase: Completed; Phase 2

Conditions: Prostatic Neoplasms

Treatments: Behavioral: Erectile Dysfunction

Study type: Interventional

Funder types: Other

Identifiers

NCT00242138

UHN REB 01-0552-C

Details and patient eligibility

About

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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.