- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04274725
Men's Experience of Prostate Biopsy
March 2, 2020 updated by: Royal Marsden NHS Foundation Trust
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
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom
- Recruiting
- Royal Marsden NHS Foundation Trust
-
Contact:
- Kathryn Myhill
- Phone Number: 02078082951
- Email: kathryn.myhill@rmh.nhs.uk
-
London, United Kingdom
- Recruiting
- Epsom General Hospital
-
Contact:
- Kathryn Myhill
- Phone Number: 02078082951
- Email: kathryn.myhill@rmh.nhs.uk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Men aged over 18
Description
- Inclusion Criteria:
- 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
- Exclusion Criteria:
- Men unable to give informed consent/ men needing a translator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To review the experience of prostate biopsy
Time Frame: two years
|
Qualitative evaluation of biopsy experience
|
two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 21, 2018
Primary Completion (Anticipated)
November 30, 2020
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
February 14, 2020
First Submitted That Met QC Criteria
February 17, 2020
First Posted (Actual)
February 18, 2020
Study Record Updates
Last Update Posted (Actual)
March 3, 2020
Last Update Submitted That Met QC Criteria
March 2, 2020
Last Verified
November 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- CCR: 4964
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Biopsy
-
Mayo ClinicClear Guide Medical Inc.Enrolling by invitation
-
Modarres HospitalCompleted
-
The University of Texas Health Science Center at...CompletedProstate Biopsy | Antibiotic TherapyUnited States
-
Rijnstate HospitalWithdrawn
-
Hospital General Universitario Gregorio MarañonRecruitingEvaluate Requirements of 2% Prilocaine in MR-UF Prostate BiopsySpain
-
Gangnam Severance HospitalUnknownTransrectal Systematic Prostate Biopsy Related PainKorea, Republic of
-
Zonguldak Bulent Ecevit UniversityRecruiting
-
Rabin Medical CenterUnknown
-
Oslo University HospitalUniversity of OsloCompletedTransperineal MRI-TRUS Fusion Guided Prostate Biopsy With vs Without Antibiotic Prophylaxis (NORAPP)Prostate Biopsy | AntibioticGermany, Norway
-
Second Military Medical UniversityCompletedLocal Anesthesia | Prostate BiopsyChina