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Completed

NCT Number: NCT04590976

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

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'.

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Key information

Conditions

Prostate Cancer Metastatic Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Health Behavior Health Care Utilization Male Urogenital Diseases Neoplasms Neoplasms by Site Patient Acceptance of Health Care Patient Satisfaction Quality of Life Radiation Injuries Radiotherapy Side Effect Surgery Treatment Adherence and Compliance Urogenital Diseases Urogenital Neoplasms Urologic Cancer Urologic Diseases Urologic Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

NHS Grampion, Aberdeen, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semi-Structured Interview Healthcare Professional

Other

Interview

Semi-Structured Interview Patients

Other

Interview

Think Aloud Interview Patients

Other

Interview

Discrete Choice Experiment (DCE) Patients

Other

DCE Questionnaire

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

    Derived from discrete choice experiment finding analysed alongside reported outcomes from ongoing therapeutic trials.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • University of Aberdeen

Registry information

Official study title

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

Acronym: IP5-MATTER

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2020
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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