NCT07135271Recruiting
BeSpoke Decision Support for Patients With Newly Diagnosed Localised Prostate Cancer
Building and Evaluating a Stratified Prostate Cancer Pathway (BeSpoke): the Impact of BeSpoke Decision Support in Patients With Newly Diagnosed Localised Prostate Cancer - a Single-blind Randomised Controlled Trial With Mixed Method Analysis
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
The goal of this randomised clinical trial is to assess whether personalised treatment counselling can improve the decision-making experience in patients with a new diagnosis of localised prostate cancer. The main question it aims to answer is: • Does the Bespoke Decision Support tool reduce decisional conflict in those choosing between treatment options for localised prostate cancer? Researchers will compare the addition of the Bespoke Decision Support tool to standard treatment counselling versus standard counselling alone. Patient participants will: * Receive standard counselling with or without access to the Bespoke Decision Support tool (based on arm of randomisation), prior to making a treatment decision. * Answer to questionnaires regarding urinary, sexual and bowel function and decision-making outcomes before and after making a treatment decision and at 3, 6, and 12 months after initiating treatment. * Take part in a qualitative interview to discuss their decision-making experience Health Care Professional participants will: • Take part in a qualitative interview to discuss their experience in providing decision support in the trial using the Bespoke Decision Support tool.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 346 (estimated)
- First submitted
- 11 Aug 2025
- Start date
- 22 Jul 2026
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- University College, London
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT07135271
What you commit to
- Study type: Interventional
- Planned participants: 346
- From 22 Jul 2026 to the primary completion date, 30 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Unsuitable for active treatment due to very low risk prostate cancer or significant health issues.
- Suspicion of metastatic prostate cancer based on clinical or imaging evidence including:
- Imaging identified suspicious lesion on bone scan, CT, whole-body MRI or PSMA-PET/CT;
- PSA ≥50 ng/mL.
- Enrolled in other localised prostate cancer studies where treatment is assigned rather than chosen by participants, e.g. PART Trial (Partial prostate Ablation vs Radical prostaTectomy)
Other
- Not able to provide informed consent.
- Insufficient English proficiency for adequate use of BeSpoke Decision Support. (Patients with support from a family member, friend or partner, to overcome lack of English proficiency will be included.)
- 1\. No experience of BeSpoke Decision Support.
Who the study is looking for
- Newly diagnosed localised prostate cancer
- Clinically suitable for at least two of the following treatment options:
- active surveillance
- focal therapy
- radical prostatectomy
- external beam radiotherapy
- Willing and able to provide informed consent
- Have seen BeSpoke Decision Support and spoken to patients in the intervention arm.
- Willing and able to provide written or electronic informed consent
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University College London Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.