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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by University Health Network, Toronto.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00496249
First received: July 3, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  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

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

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 Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Neil Fleshner, MD University Health Network, Toronto
  More Information

No publications provided

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

Keywords provided by University Health Network, Toronto:
Prostate
cancer
brachytherapy
 radiation
semen
fertility

Additional relevant MeSH terms:
Infertility
Prostatic Neoplasms
Genital Diseases, Male
Genital Diseases, Female
Genital Neoplasms, Male
 Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013