Metastatic Prostate Cancer Men's Attitudes Towards Treatment of the Local Tumour and Metastasis Evaluative Research
IP5-MATTER
Patients' Preferences in the Treatment of Hormone-sensitive Metastatic Prostate Cancer: a Discrete Choice Experiment
1 other identifier
observational
320
1 country
35
Brief Summary
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'.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Typical duration for all trials
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedStudy Start
First participant enrolled
December 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedFebruary 8, 2023
February 1, 2023
2.2 years
August 5, 2020
February 6, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Treatment attribute preferences as assessed using a study-specific 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
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 Outcomes (1)
Willingness to accept the potential effect sizes that are shown in trials.
Through study completion, an average of 1 year [Stage 3] (Discrete Choice Experiment (DCE) Questionnaire). No scale.
Study Arms (4)
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
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
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.
Stage 3 (n = 300)
Intervention: Single, Discrete Choice Experiment Questionnaire at Enrollment Visit
Interventions
Eligibility Criteria
Men with newly-diagnosed hormone-sensitive metastatic prostate cancer who have not consented to a form of local cytoreductive or metastasis directed therapy.
You may qualify if:
- Diagnosed with prostate cancer within 4 months of screening visit
- Performance status 0-2
You may not qualify if:
- Castrate-resistant metastatic prostate cancer
- Patient has consented to a form of local cytoreductive treatment to prostate
- Patient has consented to a form of metastasis directed therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- University of Aberdeencollaborator
Study Sites (35)
NHS Grampion
Aberdeen, United Kingdom
Besti Cadwaladr University
Bangor, United Kingdom
Ysbyty Gwynedd Hospital
Bangor, United Kingdom
Hamphire Hospitals NHS Foundation Trust
Basingstoke, United Kingdom
Royal Bath United Hospital
Bath, United Kingdom
Bedford Hospital
Bedford, United Kingdom
Royal Bolton Hospital
Bolton, United Kingdom
Brighton and Sussex hospital
Brighton, United Kingdom
East Suffolk and North Essex NHS Foundation Trust
Colchester, United Kingdom
Dartford and Gravsham NHS Trust
Dartford, United Kingdom
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Medway NHS Foundation Trust
Gillingham, United Kingdom
Northern Lincolnshire and Goole NHS Foundation Trust
Grimsby, United Kingdom
Royal Surrey County Hospital NHS Foundation Trust
Guildford, United Kingdom
Imperial College London
Hammersmith, United Kingdom
North Tees and Hartlepool NHS Foundation Trust
Hartlepool, United Kingdom
West Middlesex University Hospital
Isleworth, TW7 6AF, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, PE30 4ET, United Kingdom
Kingston Hospital NHS Foundation Trust
Kingston, United Kingdom
Chelsea and Westminster Hospital
London, SW10 9NH, United Kingdom
Imperial College Healthcare NHS Trust
London, W6 8RF, United Kingdom
The Royal Marsden NHS Foundation Trust, Chelsea Research Centre
London, United Kingdom
Luton and Dunstable University Hospital
Luton, United Kingdom
Wirral University Teaching Hospital Nhs Foundation
Metropolitan Borough of Wirral, United Kingdom
Freeman Hospital, Newcastle, Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
Nottingham University Hospital
Nottingham, United Kingdom
University Hospitals Dorset NHS Foundation Trust
Poole, United Kingdom
East Surrey Hospital
Redhill, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, United Kingdom
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust (UHS)
Southampton, United Kingdom
East and North Hertfordshire Nhs Trust
Stevenage, United Kingdom
Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust
Sunderland, United Kingdom
Musgrove Park Hospital - Somerset NHS Foundation Trust
Taunton, United Kingdom
The Royal Cornwall Hospital
Truro, United Kingdom
Wrexham Maelor
Wrexham, United Kingdom
Related Publications (1)
Connor MJ, Genie MG, Gonzalez M, Sarwar N, Thippu Jayaprakash K, Horan G, Hosking-Jervis F, Klimowska-Nassar N, Sukumar J, Pokrovska T, Basak D, Robinson A, Beresford M, Rai B, Mangar S, Khoo V, Dudderidge T, Falconer A, Winkler M, Watson V, Ahmed HU. Metastatic prostate cancer men's attitudes towards treatment of the local tumour and metastasis evaluative research (IP5-MATTER): protocol for a prospective, multicentre discrete choice experiment study. BMJ Open. 2021 Nov 18;11(11):e048996. doi: 10.1136/bmjopen-2021-048996.
PMID: 34794989DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hashim Ahmed, PhD, FRCS
Imperial College London
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2020
First Posted
October 19, 2020
Study Start
December 3, 2020
Primary Completion
February 1, 2023
Study Completion
February 1, 2023
Last Updated
February 8, 2023
Record last verified: 2023-02