Metastatic Prostate Cancer Men's Attitudes Towards Treatment of the Local Tumour and Metastasis Evaluative Research (IP5-MATTER)

Imperial College London

Status: Completed

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT04590976

276834

Details and patient eligibility

About

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'.

Full 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.

Enrollment: 320 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

320 participants in 4 patient groups

Healthcare Professionals (n = 5)

Description:

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

Treatment:

Other: Semi-Structured Interview Healthcare Professional

Stage 1 (n = 5)

Description:

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

Treatment:

Other: Semi-Structured Interview Patients

Stage 2 (n = 10)

Description:

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.

Treatment:

Other: Think Aloud Interview Patients

Stage 3 (n = 300)

Description:

Intervention: Single, Discrete Choice Experiment Questionnaire at Enrollment Visit

Treatment:

Other: Discrete Choice Experiment (DCE) Patients