Metastatic Prostate Cancer Men's Attitudes Towards Treatment of the Local Tumour and Metastasis Evaluative Research (IP5-MATTER)

February 6, 2023 updated by: Imperial College London

Patients' Preferences in the Treatment of Hormone-sensitive Metastatic Prostate Cancer: a Discrete Choice Experiment

Systemic therapy (i.e Androgen Deprivation Therapy with Docetaxel, Enzalutamide, Apalutamide or Abiraterone Acetate) has increased overall survival in men with hormone-sensitive metastatic prostate cancer.

Novel local cytoreductive treatments and metastasis directed therapy are being evaluated, these can confer additional harm, but might improve survival.

We aim to elicit men's preferences for and willingness to accept trade-offs between potential improved survival and cytoreductive treatment risks using a 'discrete choice experiment'.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: To determine the attributes associated with treatment that are most important to men with hormone-sensitive metastatic prostate cancer (mPCa). To determine men's preferences for, and trade-offs between, the attributes (survival and side-effects) of different treatment options in metastatic prostate cancer including systemic therapy, local and metastases-directed physical therapies.

PHASE: Prospective multi-centre observational cohort

DESIGN: Discrete choice experiment, single-visit, electronic questionnaire design

SAMPLE SIZE: Multi-centre Stage (Stage 3) n = 300 patients

POPULATION: Men with newly-diagnosed metastatic prostate cancer who have not consented to a form of local cytoreductive or metastasis directed therapy.

Study Type

Observational

Enrollment (Actual)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom
        • NHS Grampion
      • Bangor, United Kingdom
        • Ysbyty Gwynedd Hospital
      • Bangor, United Kingdom
        • Besti Cadwaladr University
      • Basingstoke, United Kingdom
        • Hamphire Hospitals NHS Foundation Trust
      • Bath, United Kingdom
        • Royal Bath United Hospital
      • Bedford, United Kingdom
        • Bedford Hospital
      • Bolton, United Kingdom
        • Royal Bolton Hospital
      • Brighton, United Kingdom
        • Brighton and Sussex Hospital
      • Colchester, United Kingdom
        • East Suffolk and North Essex NHS Foundation Trust
      • Dartford, United Kingdom
        • Dartford and Gravsham NHS Trust
      • Exeter, United Kingdom
        • Royal Devon and Exeter Hospital
      • Gillingham, United Kingdom
        • Medway NHS Foundation Trust
      • Grimsby, United Kingdom
        • Northern Lincolnshire and Goole Nhs Foundation Trust
      • Guildford, United Kingdom
        • Royal Surrey County Hospital NHS Foundation Trust
      • Hammersmith, United Kingdom
        • Imperial College London
      • Hartlepool, United Kingdom
        • North Tees and Hartlepool NHS Foundation Trust
      • Isleworth, United Kingdom, TW7 6AF
        • West Middlesex University Hospital
      • King's Lynn, United Kingdom, PE30 4ET
        • Queen Elizabeth Hospital
      • Kingston, United Kingdom
        • Kingston Hospital Nhs Foundation Trust
      • London, United Kingdom, SW10 9NH
        • Chelsea And Westminster Hospital
      • London, United Kingdom, W6 8RF
        • Imperial College Healthcare NHS Trust
      • London, United Kingdom
        • The Royal Marsden NHS Foundation Trust, Chelsea Research Centre
      • Luton, United Kingdom
        • Luton and Dunstable University Hospital
      • Newcastle Upon Tyne, United Kingdom
        • Freeman Hospital, Newcastle, Newcastle upon Tyne Hospitals NHS Foundation Trust
      • Nottingham, United Kingdom
        • Nottingham University Hospital
      • Poole, United Kingdom
        • University Hospitals Dorset NHS Foundation Trust
      • Redhill, United Kingdom
        • East Surrey Hospital
      • Shrewsbury, United Kingdom
        • Royal Shrewsbury Hospital
      • Southampton, United Kingdom
        • Southampton General Hospital, University Hospital Southampton NHS Foundation Trust (UHS)
      • Stevenage, United Kingdom
        • East and North Hertfordshire NHS Trust
      • Sunderland, United Kingdom
        • Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust
      • Taunton, United Kingdom
        • Musgrove Park Hospital - Somerset NHS Foundation Trust
      • Truro, United Kingdom
        • The Royal Cornwall Hospital
      • Wirral, United Kingdom
        • Wirral University Teaching Hospital NHS Foundation
      • Wrexham, United Kingdom
        • Wrexham Maelor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Men with newly-diagnosed hormone-sensitive metastatic prostate cancer who have not consented to a form of local cytoreductive or metastasis directed therapy.

Description

Inclusion Criteria:

  1. Diagnosed with prostate cancer within 4 months of screening visit
  2. Performance status 0-2

Exclusion Criteria:

  1. Castrate-resistant metastatic prostate cancer
  2. Patient has consented to a form of local cytoreductive treatment to prostate
  3. Patient has consented to a form of metastasis directed therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthcare Professionals (n = 5)
Intervention: Single, Semi-Structure Interview to identify and define the key attributes associated with treatment options that would warrant trade-off evaluation. These will be used to create the first version of the questionnaire
Other: Semi-Structured Interview Healthcare Professional
Interview
Stage 1 (n = 5)
Intervention: Single, Semi-Structure Interview to identify and define the key attributes associated with treatment options that would warrant trade-off evaluation. These will be used to create the first version of the questionnaire
Other: Semi-Structured Interview Patients
Interview
Stage 2 (n = 10)
Intervention: Single, "Think Aloud Interview" Interview. These will be analysed using an inductive thematic analysis by at least two researchers. Common themes will be extracted by researchers individually and then discussed and agreed.
Other: Think Aloud Interview Patients
Interview
Stage 3 (n = 300)
Intervention: Single, Discrete Choice Experiment Questionnaire at Enrollment Visit
Other: Discrete Choice Experiment (DCE) Patients
DCE Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment attribute preferences as assessed using a study-specific think aloud interview.
Time Frame: Through study completion, an average of 3 months [Stage 2] (Think Aloud Interview).
Qualitative work derived from "Think Aloud Interviews". Treatments include radiotherapy, surgery, ablation and metastasis directed therapy.
Through study completion, an average of 3 months [Stage 2] (Think Aloud Interview).
Willingness to accept treatment attributes, and trade-offs between these, using a study-specific Discrete Choice Experiment (DCE) Questionnaire
Time Frame: Through study completion, an average of 1 year [Stage 3] (Discrete Choice Experiment (DCE) Questionnaire). Trade-off from Marginal Rate of Substitution calculate as percentage points (0 to 100).
Utility values obtained via multinominal logit estimates from discrete choice experiment
Through study completion, an average of 1 year [Stage 3] (Discrete Choice Experiment (DCE) Questionnaire). Trade-off from Marginal Rate of Substitution calculate as percentage points (0 to 100).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Willingness to accept the potential effect sizes that are shown in trials.
Time Frame: Through study completion, an average of 1 year [Stage 3] (Discrete Choice Experiment (DCE) Questionnaire). No scale.
Derived from discrete choice experiment finding analysed alongside reported outcomes from ongoing therapeutic trials.
Through study completion, an average of 1 year [Stage 3] (Discrete Choice Experiment (DCE) Questionnaire). No scale.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

University of Aberdeen

Investigators

  • Principal Investigator: Hashim Ahmed, PhD, FRCS, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 3, 2020

Primary Completion (ACTUAL)

February 1, 2023

Study Completion (ACTUAL)

February 1, 2023

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

October 15, 2020

First Posted (ACTUAL)

October 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 276834

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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