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

Quality of Life Clinical Trial

— IP5-MATTER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04590976
• Other study ID #: 276834
• Status: Completed
• Start date: December 3, 2020
• Est. completion date: February 1, 2023

Study information

• Verified date: February 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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'.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Care Utilization
• Patient Satisfaction
• Prostate Cancer Metastatic
• Prostatic Neoplasms
• Quality of Life
• Radiotherapy Side Effect
• Surgery
• Urologic Cancer
• Urologic Neoplasms

Intervention

Other:
• Semi-Structured Interview Healthcare Professional
Interview
• Semi-Structured Interview Patients
Interview
• Think Aloud Interview Patients
Interview
• Discrete Choice Experiment (DCE) Patients
DCE Questionnaire

Locations

Country	Name	City	State
United Kingdom	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
United Kingdom	Queen Elizabeth Hospital	King's Lynn
United Kingdom	Kingston Hospital NHS Foundation Trust	Kingston
United Kingdom	Chelsea and Westminster Hospital	London
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	The Royal Marsden NHS Foundation Trust, Chelsea Research Centre	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	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	Wirral University Teaching Hospital Nhs Foundation	Wirral
United Kingdom	Wrexham Maelor	Wrexham

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	Willingness to accept the potential effect sizes that are shown in trials.	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.