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

NCT ID: NCT04590976

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-03

Study Completion Date

2023-02-01

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Semi-Structured Interview Healthcare Professional

Intervention Type OTHER

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

Semi-Structured Interview Patients

Intervention Type OTHER

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.

Think Aloud Interview Patients

Intervention Type OTHER

Interview

Stage 3 (n = 300)

Intervention: Single, Discrete Choice Experiment Questionnaire at Enrollment Visit

Discrete Choice Experiment (DCE) Patients

Intervention Type OTHER

DCE Questionnaire

Interventions

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Semi-Structured Interview Healthcare Professional

Interview

Intervention Type OTHER

Semi-Structured Interview Patients

Interview

Intervention Type OTHER

Think Aloud Interview Patients

Interview

Intervention Type OTHER

Discrete Choice Experiment (DCE) Patients

DCE Questionnaire

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Aberdeen

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hashim Ahmed, PhD, FRCS

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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NHS Grampion

Aberdeen, , United Kingdom

Site Status

Besti Cadwaladr University

Bangor, , United Kingdom

Site Status

Ysbyty Gwynedd Hospital

Bangor, , United Kingdom

Site Status

Hamphire Hospitals NHS Foundation Trust

Basingstoke, , United Kingdom

Site Status

Royal Bath United Hospital

Bath, , United Kingdom

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Bedford Hospital

Bedford, , United Kingdom

Site Status

Royal Bolton Hospital

Bolton, , United Kingdom

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Brighton and Sussex hospital

Brighton, , United Kingdom

Site Status

East Suffolk and North Essex NHS Foundation Trust

Colchester, , United Kingdom

Site Status

Dartford and Gravsham NHS Trust

Dartford, , United Kingdom

Site Status

Royal Devon and Exeter Hospital

Exeter, , United Kingdom

Site Status

Medway NHS Foundation Trust

Gillingham, , United Kingdom

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Northern Lincolnshire and Goole NHS Foundation Trust

Grimsby, , United Kingdom

Site Status

Royal Surrey County Hospital NHS Foundation Trust

Guildford, , United Kingdom

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Imperial College London

Hammersmith, , United Kingdom

Site Status

North Tees and Hartlepool NHS Foundation Trust

Hartlepool, , United Kingdom

Site Status

West Middlesex University Hospital

Isleworth, , United Kingdom

Site Status

Queen Elizabeth Hospital

Kings Lynn, , United Kingdom

Site Status

Kingston Hospital NHS Foundation Trust

Kingston, , United Kingdom

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Chelsea and Westminster Hospital

London, , United Kingdom

Site Status

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

The Royal Marsden NHS Foundation Trust, Chelsea Research Centre

London, , United Kingdom

Site Status

Luton and Dunstable University Hospital

Luton, , United Kingdom

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Wirral University Teaching Hospital Nhs Foundation

Metropolitan Borough of Wirral, , United Kingdom

Site Status

Freeman Hospital, Newcastle, Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, , United Kingdom

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Nottingham University Hospital

Nottingham, , United Kingdom

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University Hospitals Dorset NHS Foundation Trust

Poole, , United Kingdom

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East Surrey Hospital

Redhill, , United Kingdom

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Royal Shrewsbury Hospital

Shrewsbury, , United Kingdom

Site Status

Southampton General Hospital, University Hospital Southampton NHS Foundation Trust (UHS)

Southampton, , United Kingdom

Site Status

East and North Hertfordshire Nhs Trust

Stevenage, , United Kingdom

Site Status

Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust

Sunderland, , United Kingdom

Site Status

Musgrove Park Hospital - Somerset NHS Foundation Trust

Taunton, , United Kingdom

Site Status

The Royal Cornwall Hospital

Truro, , United Kingdom

Site Status

Wrexham Maelor

Wrexham, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 34794989 (View on PubMed)

Other Identifiers

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276834

Identifier Type: -

Identifier Source: org_study_id

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