Prostate Cancer MetastaticIP5-MATTERNCT04590976
Metastatic Prostate Cancer Men's Attitudes Towards Treatment of the Local Tumour and Metastasis Evaluative Research
An observational study of Prostate Cancer Metastatic and Radiotherapy Side Effect, run by Imperial College London at 35 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic, Radiotherapy Side Effect, Surgery
- What is being tested?
- Semi-Structured Interview Healthcare Professional, Semi-Structured Interview Patients and Think Aloud Interview Patients
- How many people
- 320 participants
- Where
- 35 sitesUnited Kingdom
- Study dates
- 3 Dec 2020to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosed with prostate cancer within 4 months of screening visit
- Performance status 0-2
Who cannot join
- 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
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United Kingdom35 sites
NHS Grampion
Aberdeen
Besti Cadwaladr University
Bangor
Ysbyty Gwynedd Hospital
Bangor
Hamphire Hospitals NHS Foundation Trust
Basingstoke
Royal Bath United Hospital
Bath
Bedford Hospital
Bedford
Royal Bolton Hospital
Bolton
Brighton and Sussex hospital
Brighton
East Suffolk and North Essex NHS Foundation Trust
Colchester
Dartford and Gravsham NHS Trust
Dartford
Royal Devon and Exeter Hospital
Exeter
Medway NHS Foundation Trust
Gillingham
Northern Lincolnshire and Goole NHS Foundation Trust
Grimsby
Royal Surrey County Hospital NHS Foundation Trust
Guildford
Imperial College London
Hammersmith
North Tees and Hartlepool NHS Foundation Trust
Hartlepool
West Middlesex University Hospital
Isleworth, TW7 6AF
Queen Elizabeth Hospital
Kings Lynn, PE30 4ET
Kingston Hospital NHS Foundation Trust
Kingston
Chelsea and Westminster Hospital
London, SW10 9NH
Imperial College Healthcare NHS Trust
London, W6 8RF
The Royal Marsden NHS Foundation Trust, Chelsea Research Centre
London
Luton and Dunstable University Hospital
Luton
Wirral University Teaching Hospital Nhs Foundation
Metropolitan Borough of Wirral
Freeman Hospital, Newcastle, Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne
Nottingham University Hospital
Nottingham
University Hospitals Dorset NHS Foundation Trust
Poole
East Surrey Hospital
Redhill
Royal Shrewsbury Hospital
Shrewsbury
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust (UHS)
Southampton
East and North Hertfordshire Nhs Trust
Stevenage
Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust
Sunderland
Musgrove Park Hospital - Somerset NHS Foundation Trust
Taunton
The Royal Cornwall Hospital
Truro
Wrexham Maelor
Wrexham
About this study
Official title: Patients' Preferences in the Treatment of Hormone-sensitive Metastatic Prostate Cancer: a Discrete Choice Experiment
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'.
Read the 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.
- Conditions
- Prostate Cancer Metastatic, Radiotherapy Side Effect, Surgery, Urologic Cancer, Quality of Life, Patient Satisfaction
- Being tested
- Semi-Structured Interview Healthcare Professional, Semi-Structured Interview Patients, Think Aloud Interview Patients, Discrete Choice Experiment (DCE) Patients
- Medical subject headings
- Radiation Injuries, Urologic Neoplasms, Patient Satisfaction, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-Structured Interview Healthcare ProfessionalOther
Interview
Semi-Structured Interview PatientsOther
Interview
Think Aloud Interview PatientsOther
Interview
Discrete Choice Experiment (DCE) PatientsOther
DCE Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Semi-Structured Interview Healthcare Professional | |
| 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 Receives: Other: Semi-Structured Interview Patients | |
| 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. Receives: Other: Think Aloud Interview Patients | |
| Stage 3 (n = 300) | Intervention: Single, Discrete Choice Experiment Questionnaire at Enrollment Visit Receives: Other: Discrete Choice Experiment (DCE) Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Derived from discrete choice experiment finding analysed alongside reported outcomes from ongoing therapeutic trials.
Measured: Through study completion, an average of 1 year [Stage 3] (Discrete Choice Experiment (DCE) Questionnaire). No scale.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start3 Dec 2020
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aberdeen
- Responsible party
- Sponsor
- Investigators
- Hashim Ahmed, PhD, FRCS, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590976
- Sponsor's protocol ID
- 276834
- Acronym
- IP5-MATTER
- Status last verified
- Feb 2023
- First submitted
- 5 Aug 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34794989
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Preferences in the Treatment of Hormone-sensitive Metastatic Prostate Cancer: a Discrete Choice Experiment
- ClinicalTrials.gov ID
- NCT04590976
- Acronym / sponsor ID
- IP5-MATTER / 276834
- Conditions
- Prostate Cancer Metastatic, Radiotherapy Side Effect, Surgery, Urologic Cancer, Quality of Life, Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- University of Aberdeen
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthcare Professionals (n = 5) | – | Other: Semi-Structured Interview Healthcare ProfessionalIntervention: 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) | – | Other: Semi-Structured Interview PatientsIntervention: 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) | – | Other: Think Aloud Interview PatientsIntervention: 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) | – | Other: Discrete Choice Experiment (DCE) PatientsIntervention: Single, Discrete Choice Experiment Questionnaire at Enrollment Visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Diagnosed with prostate cancer within 4 months of screening visit
- Performance status 0-2
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-Structured Interview Healthcare ProfessionalInterview | Other | Healthcare Professionals (n = 5) |
| Semi-Structured Interview PatientsInterview | Other | Stage 1 (n = 5) |
| Think Aloud Interview PatientsInterview | Other | Stage 2 (n = 10) |
| Discrete Choice Experiment (DCE) PatientsDCE Questionnaire | Other | Stage 3 (n = 300) |
Primary outcome
Treatment attribute preferences as assessed using a study-specific think aloud interview.
Time frame: 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
Time frame: 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
1 secondary outcome
Willingness to accept the potential effect sizes that are shown in trials.
Time frame: Through study completion, an average of 1 year [Stage 3] (Discrete Choice Experiment (DCE) Questionnaire). No scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 34794989Connor 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hashim Ahmed, PhD, FRCS principal investigator
Imperial College London
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer Metastatic and Radiotherapy Side Effect, run by Imperial College London at 35 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment attribute preferences as assessed using a study-specific think aloud interview. (time frame: Through study completion, an average of 3 months [Stage 2] (Think Aloud Interview).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04590976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.