Localised Prostate CancerBeSpokeNCT07135271
BeSpoke Decision Support for Patients With Newly Diagnosed Localised Prostate Cancer
A study testing Bespoke Decision Support tool in people with Localised Prostate Cancer, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Localised Prostate Cancer
- What is being tested?
- Bespoke Decision Support tool
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 346 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jul 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Willing and able to provide informed consent
- Have seen BeSpoke Decision Support and spoken to patients in the intervention arm.
- Willing and able to provide written or electronic informed consent
Who cannot join
- 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)
- 1. No experience of BeSpoke Decision Support.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
NCITA Clinical Trial Unit contact
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospitals NHS Foundation Trust
London, NW1 2BU
Davide Maffei, +44 20 3108 2718, davide.maffei@nhs.net
Caroline M Moore
About this study
Official title: Building and Evaluating a Stratified Prostate Cancer Pathway (BeSpoke): the Impact of BeSpoke Decision Support in Patients With Newly Diagnosed Localised Prostate Cancer - a Single-blind Randomised Controlled Trial With Mixed Method Analysis
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?
Read more
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.
Read the 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
- Being tested
- Bespoke Decision Support tool, Standard of Care (SOC) decision support material
- Keywords
- Localised Prostate Cancer, Patient Decision Aid, Shared Decision Making, Randomised Clinical Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bespoke Decision Support toolOther
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 materialOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | Placebo comparator | Standard of Care Counselling information Receives: Other: Standard of Care (SOC) decision support material |
| BeSpoke Decision Support | Experimental | Standard of care counselling plus access to BeSpoke Decision Support tool Receives: Other: Bespoke Decision Support tool; Other: Standard of Care (SOC) decision support material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Scale (DCS)
Mean difference in DCS between control (SOC) arm and intervention (Bespoke Decision Support) groups.
Scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict].
Measured: After treatment decision is confirmed, assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment.
Secondary outcomes (10)
Preparation for Decision Making (PrepDM) Scale
Mean difference in PrepDM Scale between control and intervention group. Scores range from 0 to 100 [higher scores indicate higher perceived level of preparation for decision making].
Measured: After treatment decision is confirmed, assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment.
Decision Self Efficacy (DSE) Scale
Mean difference in the DSE score between the control and the intervention groups.
Scores range from 0 [not at all confident] to 100 [very confident].
Measured: After treatment decision is confirmed, assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment.
Satisfaction With Decision (SWD) Scale
Mean difference in the SWD score between the control and the intervention groups. Scores range from 1 to 5 (5=higher satisfaction).
Measured: Measured at multiple time points: after treatment decision is confirmed (assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment); and at 3, 6 and 12 months from the treatment date.
Decision Regret Scale (DRS)
Mean difference in the DRS score between the control and the intervention groups.
Scores range from 0 [no regret] to 100 [high regret].
Measured: Measured at multiple time points: after treatment decision is confirmed (assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment); and at 3, 6 and 12 months from the treatment date.
Satisfaction with Cancer Information Profile (SCIP) Scale
Mean difference in the SCIP score between the control and the intervention groups at time-point 1 and time-point 4.
Scores for the sub-scale "Satisfaction with the amount and content of information" range from 1 to 14 (14=higher satisfaction).
Scores for the sub-scale "Satisfaction with the form and timing of information" range from 7 (lower satisfaction) to 35 (higher satisfaction).
Measured: Measured after treatment decision is confirmed (assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment) and at 12 months after treatment initiation.
Control Preference Scale (CPS)
Frequencies and proportion of the CPS categories in both the intervention and the control group.
Measured: Measured at enrolment and after treatment decision is confirmed (assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment).
Hospital Anxiety and Depression Scale (HADS)
Frequencies and proportion of the HADS categories in both the intervention and the control group.
Scores range from 0 to 21: 0-7 = Normal; 8-10 = Borderline abnormal (borderline case); 11-21 = Abnormal (case).
Measured: Measured before giving intervention, and after 3, 6 and 12 months from treatment initiation.
Decisional Conflict Scale (DCS) Subscales
Means or medians of the intervention and the control groups for the different DCS sub-scores:
- Informed sub-score (Scores range from 0 [feels extremely informed] to 100 [feels extremely uninformed]);
- Values Clarity sub-score(Scores range from 0 [feels extremely clear about personal values for benefits \& risk/side effects] to 100 [feels extremely unclear about personal values]);
- Support sub-score (Scores range from 0 [ feels extremely supported in decision making] to 100 [feels extremely unsupported in decision making]);
- Uncertainty sub-score (Scores range from 0 [feels extremely certain about best choice] to 100 [feels extremely uncertain about best choice]);
- Effective Decision sub-score (Scores range from 0 [good decision] to 100 [bad decision]).
Measured: After treatment decision is confirmed, assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment.
Qualitative Assessment with Patients
Qualitative interview evaluating patient experience in treatment decision making and feedback on decision support material
Measured: Between treatment decision being recorded and end of study (12 months after treatment initiation)
Qualitative assessment with Health Care Professionals (HCP)
Qualitative interviews with HCP (urologists, clinical oncologists, clinical nurse specialists, GPs) involved in the treatment decision making pathway of patients with prostate cancer, to inquire regarding the decision support material provided as standard of care and in the intervention arm.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start22 Jul 2026
- Primary completionNov 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localised Prostate CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline M Moore, MD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135271
- Sponsor's protocol ID
- 176848
- Other IDs
- IRAS 347220, 25/LO/0394
- Acronym
- BeSpoke
- Status last verified
- Jul 2026
- First submitted
- 11 Aug 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Any request to share IPD from other researchers will be evaluated by the Trial Steering Committee on an ad hoc basis.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building and Evaluating a Stratified Prostate Cancer Pathway (BeSpoke): the Impact of BeSpoke Decision Support in Patients With Newly Diagnosed Localised Prostate Cancer - a Single-blind Randomised Controlled Trial With Mixed Method Analysis
- ClinicalTrials.gov ID
- NCT07135271
- Acronym / sponsor ID
- BeSpoke / 176848
- Conditions
- Localised Prostate Cancer
- Keywords
- Localised Prostate Cancer, Patient Decision Aid, Shared Decision Making, Randomised Clinical Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | Placebo comparator | Other: Standard of Care (SOC) decision support materialStandard of Care Counselling information |
| BeSpoke Decision Support | Experimental | Other: Bespoke Decision Support tool, Other: Standard of Care (SOC) decision support materialStandard of care counselling plus access to BeSpoke Decision Support tool |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Newly diagnosed localised prostate cancer
- Clinically suitable for at least two of the following treatment options:
- Willing and able to provide informed consent
- Have seen BeSpoke Decision Support and spoken to patients in the intervention arm.
- Willing and able to provide written or electronic informed consent
Key exclusion criteria (8 listed)
- 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:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bespoke Decision Support toolA 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. | Other | BeSpoke Decision Support |
| Standard of Care (SOC) decision support materialStandard 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. | Other | BeSpoke Decision Support, Standard of Care (SOC) |
Primary outcome
Decisional Conflict Scale (DCS)
Time frame: After treatment decision is confirmed, assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment.
Mean difference in DCS between control (SOC) arm and intervention (Bespoke Decision Support) groups. Scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict].
10 secondary outcomes
Preparation for Decision Making (PrepDM) Scale
Time frame: After treatment decision is confirmed, assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment.
Decision Self Efficacy (DSE) Scale
Time frame: After treatment decision is confirmed, assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment.
Satisfaction With Decision (SWD) Scale
Time frame: Measured at multiple time points: after treatment decision is confirmed (assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment); and at 3, 6 and 12 months from the treatment date.
Decision Regret Scale (DRS)
Time frame: Measured at multiple time points: after treatment decision is confirmed (assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment); and at 3, 6 and 12 months from the treatment date.
Satisfaction with Cancer Information Profile (SCIP) Scale
Time frame: Measured after treatment decision is confirmed (assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment) and at 12 months after treatment initiation.
Control Preference Scale (CPS)
Time frame: Measured at enrolment and after treatment decision is confirmed (assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment).
Hospital Anxiety and Depression Scale (HADS)
Time frame: Measured before giving intervention, and after 3, 6 and 12 months from treatment initiation.
Decisional Conflict Scale (DCS) Subscales
Time frame: After treatment decision is confirmed, assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment.
Qualitative Assessment with Patients
Time frame: Between treatment decision being recorded and end of study (12 months after treatment initiation)
Qualitative assessment with Health Care Professionals (HCP)
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Prostate Cancer: A guide if you've just been diagnosed - Prostate Cancer UKLink provided by the sponsor.
- Individual participant dataSharing planned: No. Any request to share IPD from other researchers will be evaluated by the Trial Steering Committee on an ad hoc basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
NCITA Clinical Trial Unit contact
Caroline M Moore, MD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bespoke Decision Support tool in people with Localised Prostate Cancer, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Davide Maffei, MD (+44 (0)20 7679 2000, d.maffei@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict Scale (DCS) (time frame: After treatment decision is confirmed, assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.