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

Study Overview
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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.

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

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

Intervention / Treatment
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* Other: Semi-Structured Interview Healthcare Professional
* Other: Semi-Structured Interview Patients
* Other: Think Aloud Interview Patients
* Other: Discrete Choice Experiment (DCE) Patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with prostate cancer within 4 months of screening visit Performance status 0-2 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthcare Professionals (n = 5)<br>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 | Other: Semi-Structured Interview Healthcare Professional<br>* Interview<br>|
| Stage 1 (n = 5)<br>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 | Other: Semi-Structured Interview Patients<br>* Interview<br>|
| Stage 2 (n = 10)<br>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. | Other: Think Aloud Interview Patients<br>* Interview<br>|
| Stage 3 (n = 300)<br>Intervention: Single, Discrete Choice Experiment Questionnaire at Enrollment Visit | Other: Discrete Choice Experiment (DCE) Patients<br>* DCE Questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |