Erectile Dysfunction/Prostate/RT/Androgen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00242138
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : February 9, 2016
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Behavioral: Erectile Dysfunction Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : March 2000
Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. This study is designed to address absolute incidence of erectile dysfunction, as measured by the International index of Erectile function.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00242138

Canada, Ontario
University Health Network Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: Padraig Warde, MD Princess Margaret Hospital, Canada Identifier: NCT00242138     History of Changes
Other Study ID Numbers: UHN REB 01-0552-C
First Posted: October 19, 2005    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Erectile Dysfunction
Prostatic Neoplasms
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs