Clinical trial NCT04590976: Metastatic Prostate Cancer Men's Attitudes Towards Treatment of the Local Tumour and Metastasis Evaluative Research
Official title: Patients' Preferences in the Treatment of Hormone-sensitive Metastatic Prostate Cancer: a Discrete Choice Experiment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer Metastatic
Radiotherapy Side Effect
Surgery
Urologic Cancer
Quality of Life
Patient Satisfaction
Health Care Utilization
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: University of Aberdeen
First posted: 2020-10-19
Enrollment: 320
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment attribute preferences as assessed using a study-specific think aloud interview.
timeFrame: Through study completion, an average of 3 months [Stage 2] (Think Aloud Interview).
measure: Willingness to accept treatment attributes, and trade-offs between these, using a study-specific Discrete Choice Experiment (DCE) Questionnaire
timeFrame: 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:
measure: Willingness to accept the potential effect sizes that are shown in trials.
timeFrame: Through study completion, an average of 1 year [Stage 3] (Discrete Choice Experiment (DCE) Questionnaire). No scale.
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: NHS Grampion
city: Bangor
country: United Kingdom
facility: Besti Cadwaladr University
city: Bangor
country: United Kingdom
facility: Ysbyty Gwynedd Hospital
city: Basingstoke
country: United Kingdom
facility: Hamphire Hospitals NHS Foundation Trust
city: Bath
country: United Kingdom
facility: Royal Bath United Hospital
city: Bedford
country: United Kingdom
facility: Bedford Hospital
city: Bolton
country: United Kingdom
facility: Royal Bolton Hospital
city: Brighton
country: United Kingdom
facility: Brighton and Sussex hospital
city: Colchester
country: United Kingdom
facility: East Suffolk and North Essex NHS Foundation Trust
city: Dartford
country: United Kingdom
facility: Dartford and Gravsham NHS Trust
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
city: Gillingham
country: United Kingdom
facility: Medway NHS Foundation Trust
city: Grimsby
country: United Kingdom
facility: Northern Lincolnshire and Goole NHS Foundation Trust
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital NHS Foundation Trust
city: Hammersmith
country: United Kingdom
facility: Imperial College London
city: Hartlepool
country: United Kingdom
facility: North Tees and Hartlepool NHS Foundation Trust
city: Isleworth
country: United Kingdom
facility: West Middlesex University Hospital
city: King's Lynn
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Kingston
country: United Kingdom
facility: Kingston Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust, Chelsea Research Centre
city: Luton
country: United Kingdom
facility: Luton and Dunstable University Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital, Newcastle, Newcastle upon Tyne Hospitals NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
city: Poole
country: United Kingdom
facility: University Hospitals Dorset NHS Foundation Trust
city: Redhill
country: United Kingdom
facility: East Surrey Hospital
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital, University Hospital Southampton NHS Foundation Trust (UHS)
city: Stevenage
country: United Kingdom
facility: East and North Hertfordshire Nhs Trust
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital - Somerset NHS Foundation Trust
city: Truro
country: United Kingdom
facility: The Royal Cornwall Hospital
city: Wirral
country: United Kingdom
facility: Wirral University Teaching Hospital Nhs Foundation
city: Wrexham
country: United Kingdom
facility: Wrexham Maelor
Study officials:
affiliation: Imperial College London
name: Hashim Ahmed, PhD, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.