Prostatic Neoplasms
Conditions
Brief 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.
Interventions
BEHAVIORALErectile Dysfunction
Sponsors
Princess Margaret Hospital, Canada
University Health Network, Toronto
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study is designed to address absolute incidence of erectile dysfunction, as measured by the International index of Erectile function. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Canada
Outcome results
None listed