NCT00496249

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

6 months

First QC Date

July 3, 2007

Last Update Submit

December 21, 2015

Conditions

Prostate Cancer

Keywords

Prostatecancerbrachytherapyradiationsemenfertility

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Men being treated with radiation therapy for localized prostate cancer who consent to participate and provide a semen specimen for analysis following thereapy.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Neil Fleshner, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2007

First Posted

July 4, 2007

Study Start

July 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

December 22, 2015

Record last verified: 2015-12

Locations

CA(1)