BeSpoke Decision Support for Patients With Newly Diagnosed Localised Prostate Cancer (NCT07135271) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
BeSpoke Decision Support for Patients With Newly Diagnosed Localised Prostate Cancer
346 participantsStarted 2026-06
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Unsuitable for active treatment due to very low risk prostate cancer or significant health issues.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial seems to focus on helping patients make treatment decisions rather than testing a new drug or procedure — could you explain what the BeSpoke decision support tool actually involves, and whether it might help me feel more confident choosing between my treatment options for localised prostate cancer?
2Since this trial is measuring something called the Decisional Conflict Scale, which tracks how uncertain or conflicted patients feel about their choices, does that mean my treatment plan itself won't change — I'll still receive standard care regardless of whether I join?
3The trial isn't recruiting yet — given that my prostate cancer has just been diagnosed, do I have time to wait and see if it opens, or should we move forward with standard treatment planning now?
4Because this is listed as Phase NA, which suggests it's not a drug trial with the usual Phase 1 through 3 safety testing, what are the actual risks or burdens I should know about before considering participation — for example, extra appointments or surveys?
5Are there other decision-support resources or tools already available to me right now that could help me weigh my treatment options, in case this trial doesn't open in time or I'm not a good fit for it?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Decisional Conflict Scale (DCS)
Timeframe: After treatment decision is confirmed, assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment.
. 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)
. Have seen BeSpoke Decision Support and spoken to patients in the intervention arm.