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

Imperial College London320 enrolled

Overview

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'.

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 Type

OBSERVATIONAL

Enrollment

320

Conditions

Prostate Cancer Metastatic Radiotherapy Side Effect Surgery Urologic Cancer

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (35)

NHS Grampion

Aberdeen, United Kingdom

Besti Cadwaladr University

Bangor, United Kingdom

Ysbyty Gwynedd Hospital

Bangor, United Kingdom

Hamphire Hospitals NHS Foundation Trust

Basingstoke, United Kingdom

Royal Bath United Hospital

Bath, United Kingdom

Bedford Hospital

Outcomes

Primary Outcomes

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.

Time frame: 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

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).

Secondary Outcomes

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.

Time frame: Through study completion, an average of 1 year [Stage 3] (Discrete Choice Experiment (DCE) Questionnaire). No scale.