Metastatic Prostate Cancer Men's Attitudes Towards Treatment of the Local Tumour and Metastasis Evaluative Research

Completed

• Conditions: Urologic Cancer; Health Care Utilization; Quality of Life; Prostate Cancer Metastatic; Radiotherapy Side Effect; Surgery; Patient Satisfaction
• Interventions: Other: Semi-Structured Interview Patients; Other: Think Aloud Interview Patients; Other: Discrete Choice Experiment (DCE) Patients; Other: Semi-Structured Interview Healthcare Professional

• Registration Number: NCT04590976
• Lead Sponsor: Imperial College London

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'.

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 Timeline

• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-19
• Study Start: 2020-12-03
• Status Verified: 2023-02
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 320

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stage 1 (n = 5)	Semi-Structured Interview Patients	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)	Think Aloud Interview Patients	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)	Discrete Choice Experiment (DCE) Patients	Intervention: Single, Discrete Choice Experiment Questionnaire at Enrollment Visit
Healthcare Professionals (n = 5)	Semi-Structured Interview Healthcare Professional	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

Primary Outcome Measures

Name	Time	Method
Treatment attribute preferences as assessed using a study-specific think aloud interview.	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.
Willingness to accept treatment attributes, and trade-offs between these, using a study-specific Discrete Choice Experiment (DCE) Questionnaire	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

Secondary Outcome Measures

Name	Time	Method
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.	Derived from discrete choice experiment finding analysed alongside reported outcomes from ongoing therapeutic trials.

Trial Locations

Locations (35)

NHS Grampion; 🇬🇧 Aberdeen, United Kingdom

Hamphire Hospitals NHS Foundation Trust; 🇬🇧 Basingstoke, United Kingdom

Royal Bolton Hospital; 🇬🇧 Bolton, United Kingdom

Dartford and Gravsham NHS Trust; 🇬🇧 Dartford, United Kingdom

Imperial College London; 🇬🇧 Hammersmith, United Kingdom

The Royal Cornwall Hospital; 🇬🇧 Truro, United Kingdom

Queen Elizabeth Hospital; 🇬🇧 King's Lynn, United Kingdom

Besti Cadwaladr University; 🇬🇧 Bangor, United Kingdom

Ysbyty Gwynedd Hospital; 🇬🇧 Bangor, United Kingdom

Bedford Hospital; 🇬🇧 Bedford, United Kingdom

Brighton and Sussex hospital; 🇬🇧 Brighton, United Kingdom

Royal Devon and Exeter Hospital; 🇬🇧 Exeter, United Kingdom

North Tees and Hartlepool NHS Foundation Trust; 🇬🇧 Hartlepool, United Kingdom

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom

Luton and Dunstable University Hospital; 🇬🇧 Luton, United Kingdom

Freeman Hospital, Newcastle, Newcastle upon Tyne Hospitals NHS Foundation Trust; 🇬🇧 Newcastle Upon Tyne, United Kingdom

Royal Surrey County Hospital NHS Foundation Trust; 🇬🇧 Guildford, United Kingdom

Northern Lincolnshire and Goole NHS Foundation Trust; 🇬🇧 Grimsby, United Kingdom

University Hospitals Dorset NHS Foundation Trust; 🇬🇧 Poole, United Kingdom

Wirral University Teaching Hospital Nhs Foundation; 🇬🇧 Wirral, United Kingdom

East Surrey Hospital; 🇬🇧 Redhill, United Kingdom

East and North Hertfordshire Nhs Trust; 🇬🇧 Stevenage, United Kingdom

Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust; 🇬🇧 Sunderland, United Kingdom

Royal Shrewsbury Hospital; 🇬🇧 Shrewsbury, United Kingdom

East Suffolk and North Essex NHS Foundation Trust; 🇬🇧 Colchester, United Kingdom

Royal Bath United Hospital; 🇬🇧 Bath, United Kingdom

Medway NHS Foundation Trust; 🇬🇧 Gillingham, United Kingdom

West Middlesex University Hospital; 🇬🇧 Isleworth, United Kingdom

Kingston Hospital NHS Foundation Trust; 🇬🇧 Kingston, United Kingdom

Nottingham University Hospital; 🇬🇧 Nottingham, United Kingdom

Chelsea and Westminster Hospital; 🇬🇧 London, United Kingdom

The Royal Marsden NHS Foundation Trust, Chelsea Research Centre; 🇬🇧 London, United Kingdom

Wrexham Maelor; 🇬🇧 Wrexham, United Kingdom

Southampton General Hospital, University Hospital Southampton NHS Foundation Trust (UHS); 🇬🇧 Southampton, United Kingdom

Musgrove Park Hospital - Somerset NHS Foundation Trust; 🇬🇧 Taunton, United Kingdom