Prostate CancerNCT04278443
Fertility After Prostate Brachytherapy
An observational study of Prostate Cancer, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Feb 2017to 5 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
Study population: Men undergoing brachytherapy for prostate cancer
Who may be able to join
- Male
- 18 years or older
- Receiving brachytherapy monotherapy; High or Low dose rate
- Ability to ejaculate
- Able to provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
East and North Hertfordshire NHS Trust
Northwood, Middlesex, HA6 2RN
Peter Hoskin, 0203 826 2438, peterhoskin@nhs.net
Lucy Collins, 0203 826 2073, lucy.collins8@nhs.net
About this study
Official title: A Single Site Prospective Descriptive Study on the Effect of Brachytherapy Monotherapy for Prostate Cancer on Male Fertility
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
Read the detailed 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.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low dose rate brachytherapy | 20 patients receiving low dose rate brachytherapy | |
| High dose rate brachytherapy | 20 patients receiving high dose rate brachytherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define effect of prostate brachytherapy on male fertility.
measure by sequential sperm counts
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start24 Feb 2017
- Primary completion5 Aug 2021 (estimated)
- Study completion5 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Collaborators
- BXTAccelyon Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278443
- Sponsor's protocol ID
- RD2016-50
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Site Prospective Descriptive Study on the Effect of Brachytherapy Monotherapy for Prostate Cancer on Male Fertility
- ClinicalTrials.gov ID
- NCT04278443
- Acronym / sponsor ID
- RD2016-50
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Collaborators
- BXTAccelyon Ltd
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 5 Aug 2021 (estimated)
- Study completion
- 5 Aug 2021 (estimated)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose rate brachytherapy | – | –20 patients receiving low dose rate brachytherapy |
| High dose rate brachytherapy | – | –20 patients receiving high dose rate brachytherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Men undergoing brachytherapy for prostate cancer
Key inclusion criteria (5 listed)
- Male
- 18 years or older
- Receiving brachytherapy monotherapy; High or Low dose rate
- Ability to ejaculate
- Able to provide written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To define effect of prostate brachytherapy on male fertility.
Time frame: 12 months
measure by sequential sperm counts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Hoskin (0203 826 2438 ext. 2438, peterhoskin@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To define effect of prostate brachytherapy on male fertility. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.