Fertility After Prostate Brachytherapy

NCT ID: NCT04278443

Last Updated: 2020-02-20

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-24

Study Completion Date

2021-08-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low dose rate brachytherapy

20 patients receiving low dose rate brachytherapy

No interventions assigned to this group

High dose rate brachytherapy

20 patients receiving high dose rate brachytherapy.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

BXTAccelyon Ltd

UNKNOWN

Sponsor Role collaborator

East and North Hertfordshire NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

East and North Hertfordshire NHS Trust

Northwood, Middlesex, United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Peter Hoskin

Role: CONTACT

0203 826 2438 ext. 2438

Shreya Armstrong

Role: CONTACT

0203 826 2145 ext. 2145

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Peter Hoskin

Role: primary

0203 826 2438

Lucy Collins

Role: backup

0203 826 2073

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RD2016-50

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

LDR vs. HDR Brachytherapy for Prostate Cancer
NCT03426748 ACTIVE_NOT_RECRUITING NA
MRI-guided Brachytherapy and Salvage SBRT Program
NCT07132671 NOT_YET_RECRUITING NA
Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection
NCT05413850 RECRUITING PHASE1/PHASE2
Focal Therapy for Prostate Cancer
NCT01802307 WITHDRAWN PHASE2
I125 Brachytherapy After TURP
NCT02370992 COMPLETED