BeSpoke Decision Support for Patients With Newly Diagnosed Localised Prostate Cancer

NCT ID: NCT07135271

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2028-06-30

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.

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 standard of care (SOC) arm includes the nationally-approved Prostate Cancer UK booklet "Prostate Cancer - A guide if you have recently been diagnosed" and patient appointments to discuss different treatments with clinicians, as per local practice that offer them. Further educational material may be provided as per local practice at each site.

The intervention arm will offer additional BeSpoke Decision Support providing:

• Consistent and up-to-date information about suitable treatment approaches.
• Risk-stratified predictions of treatment outcomes based on baseline cancer and patient characteristics.
• Value clarification about which attributes of treatment are most important to the individual.

All participants will complete questionnaires on demographic data, functional status and measures of decision-making experiences at several time points: enrolment (prior to treatment discussion consultation); after treatment decision has taken place; at 3, 6, and 12 months after treatment commences.

The investigators will interview health care professionals and a sample of patient participants to assess the effect of the BeSpoke Decision Support and the challenges in implementation across the NHS.

Conditions

Localised Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Standard of Care (SOC)

Standard of Care Counselling information

Group Type: PLACEBO_COMPARATOR

Standard of Care (SOC) decision support material

Intervention Type: OTHER

Standard of care information to inform the prostate cancer treatment decision. This includes the nationally approved Prostate Cancer UK information booklet "Prostate Cancer - A guide if you have just been diagnosed" in all sites. Further educational material may be provided as part of standard of care depending on local practice at each site.

BeSpoke Decision Support

Standard of care counselling plus access to BeSpoke Decision Support tool

Group Type: EXPERIMENTAL

Bespoke Decision Support tool

Intervention Type: OTHER

A newly-developed online patient decision aid offering comparative information of prostate cancer treatments (active surveillance, focal therapy, radical prostatectomy and external beam radiotherapy), personalised estimates of oncological and functional outcomes for each treatment and a value-clarification exercise.

Standard of Care (SOC) decision support material

Intervention Type: OTHER

Standard of care information to inform the prostate cancer treatment decision. This includes the nationally approved Prostate Cancer UK information booklet "Prostate Cancer - A guide if you have just been diagnosed" in all sites. Further educational material may be provided as part of standard of care depending on local practice at each site.

Interventions

Bespoke Decision Support tool

A newly-developed online patient decision aid offering comparative information of prostate cancer treatments (active surveillance, focal therapy, radical prostatectomy and external beam radiotherapy), personalised estimates of oncological and functional outcomes for each treatment and a value-clarification exercise.

Intervention Type: OTHER

Standard of Care (SOC) decision support material

Standard of care information to inform the prostate cancer treatment decision. This includes the nationally approved Prostate Cancer UK information booklet "Prostate Cancer - A guide if you have just been diagnosed" in all sites. Further educational material may be provided as part of standard of care depending on local practice at each site.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

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)

1. No experience of BeSpoke Decision Support.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline M Moore, MD

Role: PRINCIPAL_INVESTIGATOR

University College, London

Central Contacts

Davide Maffei, MD

Role: CONTACT

d.maffei@ucl.ac.uk

+44 (0)20 7679 2000

NCITA Clinical Trial Unit

Role: CONTACT

ncita.bespoke@ucl.ac.uk

Related Links

https://shop.prostatecanceruk.org/pdf/publication/prostate-cancer-a-guide-if-youve-just-been-diagnosed_ifm.pdf

Prostate Cancer: A guide if you've just been diagnosed - Prostate Cancer UK

Other Identifiers

IRAS 347220

Identifier Type: OTHER

Identifier Source: secondary_id

25/LO/0394

Identifier Type: OTHER

Identifier Source: secondary_id

176848

Identifier Type: -

Identifier Source: org_study_id