NCT04278443

Brief Summary

Although brachytherapy toxicity data on erectile dysfunction, urethral dysfunction and bladder and bowel impact has been collected for a number of years, there is limited information on its effect on male fertility. This study aims to investigate the effect of brachytherapy on fertility

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 24, 2017

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2021

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

4.4 years

First QC Date

February 18, 2020

Last Update Submit

February 18, 2020

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • To define effect of prostate brachytherapy on male fertility.

    measure by sequential sperm counts

    12 months

Study Arms (2)

Low dose rate brachytherapy

20 patients receiving low dose rate brachytherapy

High dose rate brachytherapy

20 patients receiving high dose rate brachytherapy.

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsStudy on male fertility, thus only male participants are eligible
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Men undergoing brachytherapy for prostate cancer

You may qualify if:

  • Male
  • years or older
  • Receiving brachytherapy monotherapy; High or Low dose rate
  • Ability to ejaculate
  • Able to provide written informed consent

You may not qualify if:

  • History of infertility or vasectomy
  • Previous chemotherapy or pelvic radiotherapy
  • Prior use of androgen deprivation therapy
  • alpha-reductase inhibitors within the last 4 months
  • Alpha blockers within 7 days of semen collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East and North Hertfordshire NHS Trust

Northwood, Middlesex, HA6 2RN, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and semen samples

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Peter Hoskin

CONTACT

0203 826 2438peterhoskin@nhs.net

Shreya Armstrong

CONTACT

0203 826 2145shreya.armstrong@nhs.net

Study Design

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

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 20, 2020

Study Start

February 24, 2017

Primary Completion

August 5, 2021

Study Completion

August 5, 2021

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

GB(1)