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

NCT ID: NCT00496249

Last Updated: 2015-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer

Keywords

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Prostate cancer brachytherapy radiation semen fertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil Fleshner, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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07-0197-CE

Identifier Type: -

Identifier Source: org_study_id