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 2025-09
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:
ā¢ 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:
ā¢ 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
SexALL
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Inclusion criteria
ā. Newly diagnosed localised prostate cancer
ā. Clinically suitable for at least two of the following treatment options:
ā. active surveillance
ā. focal therapy
ā. radical prostatectomy
ā. external beam radiotherapy
ā. Willing and able to provide informed consent
Exclusion criteria
ā. Unsuitable for active treatment due to very low risk prostate cancer or significant health issues.
ā. Suspicion of metastatic prostate cancer based on clinical or imaging evidence including:
ā. Imaging identified suspicious lesion on bone scan, CT, whole-body MRI or PSMA-PET/CT;
ā. PSA ā„50 ng/mL.
ā. Not able to provide informed consent.
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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.
. 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.)
ā. 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)
ā. Have seen BeSpoke Decision Support and spoken to patients in the intervention arm.