Status:
NOT_YET_RECRUITING
BeSpoke Decision Support for Patients With Newly Diagnosed Localised Prostate Cancer
Lead Sponsor:
University College, London
Conditions:
Localised Prostate Cancer
Eligibility:
All Genders
Phase:
NA
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 can...
Detailed Description
Recruited patient participants will be randomised into two arms: * Standard of Care (SOC) arm: SOC counselling * Intervention arm: SOC counselling plus access to BeSpoke Decision Support The standar...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Patient-Participants:
- 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
- Exclusion Criteria for Patient Participants:
- 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.
- 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.)
- 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:
- Have seen BeSpoke Decision Support and spoken to patients in the intervention arm.
- Willing and able to provide written or electronic informed consent
- Exclusion criteria for Health Care Professionals
- 1\. No experience of BeSpoke Decision Support.
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT07135271
Start Date
September 1 2025
End Date
June 1 2028
Last Update
August 22 2025
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