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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496249
• Other study ID #: 07-0197-CE
• Status: Completed
• Phase: N/A
• First received: July 3, 2007
• Last updated: December 21, 2015
• Start date: July 2007
• Est. completion date: January 2008

Study information

• Verified date: December 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada,