Prostate BiopsyNCT04274725
Men's Experience of Prostate Biopsy
An observational study of Prostate Biopsy, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
Men aged over 18 having a first or second diagnostic prostate biopsy at the Royal Marsden NHS Foundation Trust or Epsom General Hospital may be invited to take part in one to one interview within 6 months of having the procedure done to talk about their experience Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Biopsy
- How many people
- 18 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 25 Jan 2019to 29 Jan 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men aged over 18
Who may be able to join
- Men aged over 18 having a first or second diagnostic prostate biopsy at either the Royal Marsden NHS Foundation Trust or Epsom General Hospital
- Within 6 months of their prostate biopsy being done
Who cannot join
- Men unable to give informed consent/ men needing a translator
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Epsom General Hospital
London
Royal Marsden NHS Foundation Trust
London
About this study
Official title: Managing the Experience of Prostate Biopsy: What Are Men's Perceptions of Their Lived Experience and Support Needs
Men aged over 18 having a first or second diagnostic prostate biopsy at the Royal Marsden NHS Foundation Trust or Epsom General Hospital may be invited to take part in one to one interview within 6 months of having the procedure done to talk about their experience
Read the detailed description
Men aged over 18 having a first or second diagnostic prostate biopsy at the Royal Marsden NHS Foundation Trust or Epsom General Hospital will be approached by their Urology team or study Researcher with an information sheet about the study pre or post biopsy. The participant information sheet outlines that the study will involve being interviewed by the researcher, Kathryn Myhill as part of her doctoral research and being asked about their perceptions of their biopsy experience and what it was like to go through it. Men who return an expression of interest reply slip by post will be contacted by the researcher or they can contact her directly via the email or phone details given in the PIS. The researcher will answer any queries about the study and explore whether they would like to take part in an interview. A one to one interview will then be offered in a non-clinical, private room at the hospital where their biopsy took place (Royal Marsden Hospital, Epsom General Hospital) or at their workplace or home.
- Conditions
- Prostate Biopsy
What is being measured
The primary outcome is the main question the study is designed to answer.
To review the experience of prostate biopsy
Qualitative evaluation of biopsy experience
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start25 Jan 2019
- Primary completion29 Jan 2025
- Study completion29 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate BiopsyStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274725
- Sponsor's protocol ID
- CCR: 4964
- Status last verified
- Apr 2025
- First submitted
- 14 Feb 2020
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing the Experience of Prostate Biopsy: What Are Men's Perceptions of Their Lived Experience and Support Needs
- ClinicalTrials.gov ID
- NCT04274725
- Acronym / sponsor ID
- CCR: 4964
- Conditions
- Prostate Biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 29 Jan 2025 (actual)
- Study completion
- 29 Jan 2025 (actual)
- First posted
- 18 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.
Men aged over 18 having a first or second diagnostic prostate biopsy at the Royal Marsden NHS Foundation Trust or Epsom General Hospital may be invited to take part in one to one interview within 6 months of having the procedure done to talk about their experience
Detailed description
Men aged over 18 having a first or second diagnostic prostate biopsy at the Royal Marsden NHS Foundation Trust or Epsom General Hospital will be approached by their Urology team or study Researcher with an information sheet about the study pre or post biopsy. The participant information sheet outlines that the study will involve being interviewed by the researcher, Kathryn Myhill as part of her doctoral research and being asked about their perceptions of their biopsy experience and what it was like to go through it. Men who return an expression of interest reply slip by post will be contacted by the researcher or they can contact her directly via the email or phone details given in the PIS. The researcher will answer any queries about the study and explore whether they would like to take part in an interview. A one to one interview will then be offered in a non-clinical, private room at the hospital where their biopsy took place (Royal Marsden Hospital, Epsom General Hospital) or at their workplace or home.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men aged over 18
Key inclusion criteria (2 listed)
- Men aged over 18 having a first or second diagnostic prostate biopsy at either the Royal Marsden NHS Foundation Trust or Epsom General Hospital
- Within 6 months of their prostate biopsy being done
Key exclusion criteria (1 listed)
- Men unable to give informed consent/ men needing a translator
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 review the experience of prostate biopsy
Time frame: two years
Qualitative evaluation of biopsy experience
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Biopsy, run by Royal Marsden NHS Foundation Trust at 2 sites 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To review the experience of prostate biopsy (time frame: two years). 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 1 May 2025.