Bespoke Decision Support for Localised Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial tests whether adding the BeSpoke Decision Support tool to standard counselling improves decision-making for men with newly diagnosed localised prostate cancer. Participants are randomized to receive standard counseling alone or standard counseling plus the BeSpoke tool, which provides up-to-date treatment information, risk-based outcome predictions, and help clarifying patient values. Outcomes include decisional conflict and patient-reported urinary, sexual, and bowel function, measured before decision-making and at 3, 6, and 12 months after starting treatment, along with qualitative interviews to explore implementation in NHS settings. The study is conducted at University College London Hospitals NHS Foundation Trust under UCL, with recruitment from eligible patients across the center.

Why it matters

Who can join: the full rules

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.

Where it's running

• University College London Hospitals NHS Foundation Trust
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Caroline M Moore, MD — University College, London
• Study coordinator: Davide Maffei, MD
• Email: d.maffei@ucl.ac.uk
• Phone: +44 (0)20 7679 2000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.