NCT07135271 BeSpoke Decision Support for Patients With Newly Diagnosed Localised Prostate Cancer
| NCT ID | NCT07135271 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University College, London |
| Condition | Localised Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 346 participants |
| Start Date | 2026-07-22 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 346 participants in total. It began in 2026-07-22 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria for Patient-Participants: 1. Newly diagnosed localised prostate cancer 2. Clinically suitable for at least two of the following treatment options: 1. active surveillance 2. focal therapy 3. radical prostatectomy 4. external beam radiotherapy 3. Willing and able to provide informed consent Exclusion Criteria for Patient Participants: 1. Unsuitable for active treatment due to very low risk prostate cancer or significant health issues. 2. Suspicion of metastatic prostate cancer based on clinical or imaging evidence including: 1. Imaging identified suspicious lesion on bone scan, CT, whole-body MRI or PSMA-PET/CT; 2. PSA ≥50 ng/mL. 3. Not able to provide informed consent. 4. 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.) 5. 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) Inclusion criteria for Health Care Professionals: 1. Have seen BeSpoke Decision Support and spoken to patients in the intervention arm. 2. Willing and able to provide written or electronic informed consent Exclusion criteria for Health Care Professionals 1\. No experience of BeSpoke Decision Support.
Contact & Investigator
Caroline M Moore, MD
PRINCIPAL INVESTIGATOR
University College, London
Frequently Asked Questions
Who can join the NCT07135271 clinical trial?
This trial is open to participants of all sexes, studying Localised Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07135271 currently recruiting?
Yes, NCT07135271 is actively recruiting participants. Contact the research team at d.maffei@ucl.ac.uk for enrollment information.
Where is the NCT07135271 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT07135271 clinical trial?
NCT07135271 is sponsored by University College, London. The principal investigator is Caroline M Moore, MD at University College, London. The trial plans to enroll 346 participants.
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