The Effect of Radiation on Semen Quality and Fertility in Men With Prostate Cancer

This study is not yet open for participant recruitment.

Verified by University Health Network, Toronto, July 2007

Sponsored by:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00496249

Purpose

Many younger men are diagnosed with prostate cancer. These patients are often choosing radiation therapy as their primary treatment. The effect of this therapy on fertility will have a direct impact on their decision about therapeutic options and fertility preservation. The researchers hypothesize that when patients are treated with radiation for localized prostate cancer, infertility can occur due to direct damage to seminiferous tubules affecting sperm quality.

Condition
Prostate Cancer

MedlinePlus related topics: Cancer Infertility Prostate Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Longitudinal, Defined Population, Prospective Study
Official Title:	The Effect of Radiation on Semen Quality and Fertility in Men Treated With External Beam Radiation or Brachytherapy for Early Stage Prostate Cancer

Further study details as provided by University Health Network, Toronto:

Estimated Enrollment:	40
Study Start Date:	July 2007
Estimated Study Completion Date:	January 2008

Detailed Description:

Prostate cancer is the most common malignant disease among men. Many young men are diagnosed with localized prostate cancer. Some of these men are choosing to manage their prostate cancer with radiation therapy. The radiation therapy delivers minimal dose exposure to adjacent organs. We hypothesize that when patients are treated with radiation therapy for localized prostate cancer, decreased fertility can occur due to damage of seminiferous tubules, which may affect sperm quality. This study will assess the impact of radiation therapy on semen and seminal fluid.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects with histologically confirmed low risk to moderate stage prostate cancer (Gleason 6 - 7) treated with brachytherapy or external beam radiation
> 12 months ago

Exclusion Criteria:

Subjects with a prior history of infertility
Subjects who have undergone vasectomy
Subjects who have received LHRH therapy for prostate cancer < 6 months ago
Subjects who have received anti-androgens < 3 months ago
Subjects using alpha blockers within 7 days of specimen provision
Subjects who have taken finasteride or dutasteride within the previous 4 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496249

Contacts

Contact: Sally Fairbairn, BSc	416 946 4501 ext 3832	sally.fairbairn@uhn.on.ca
Contact: Karen Hersey, RN	416 946 2155	karen.hersey@uhn.on.ca

Locations

Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:

Neil Fleshner, MD

University Health Network, Toronto

More Information

Study ID Numbers:	07-0197-CE
Study First Received:	July 3, 2007
Last Updated:	July 3, 2007
ClinicalTrials.gov Identifier:	NCT00496249
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:

Prostate
cancer
brachytherapy

radiation
semen
fertility

Study placed in the following topic categories:

Infertility
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009