Fertility After Prostate Brachytherapy

Prostate Cancer Clinical Trial

Official title:

A Single Site Prospective Descriptive Study on the Effect of Brachytherapy Monotherapy for Prostate Cancer on Male Fertility

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04278443
• Other study ID #: RD2016-50
• Status: Recruiting
• Start date: February 24, 2017
• Est. completion date: August 5, 2021

Study information

• Verified date: February 2020
• Source: East and North Hertfordshire NHS Trust
• Contact: Peter Hoskin
• Phone: 0203 826 2438
• Email: peterhoskin[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

Brachytherapy is a commonly employed technique in the treatment of all prostate cancer risk groups. It delivers a high radiation localised to the prostate gland. The effects of this on fertility have not been systematically studied. An increasing number of younger men for whom fertility is an issue are being diagnosed with prostate cancer and may be offered brachytherapy amongst their treatment choices. This study therefore addresses this issue with a systematic evaluation of sperm count and quality before and after both high dose rate and low dose rate brachytherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 5, 2021
• Est. primary completion date: August 5, 2021
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male

• 18 years or older

• Receiving brachytherapy monotherapy; High or Low dose rate

• Ability to ejaculate

• Able to provide written informed consent

Exclusion Criteria:

• History of infertility or vasectomy

• Previous chemotherapy or pelvic radiotherapy

• Prior use of androgen deprivation therapy

• 5 alpha-reductase inhibitors within the last 4 months

• Alpha blockers within 7 days of semen collection

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United Kingdom	East and North Hertfordshire NHS Trust	Northwood	Middlesex

Sponsors (2)

Lead Sponsor	Collaborator
East and North Hertfordshire NHS Trust	BXTAccelyon Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To define effect of prostate brachytherapy on male fertility.	measure by sequential sperm counts	12 months