Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients (ADAPT-P)

Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients, a Multicentre Prospective Observational Study

The ADAPT study is an observational study of apalutamide, which can be given to patients with hormone sensitive metastatic prostate cancer as standard of care. The clinical decision for patients to have apalutamide as part of their management plan will be decided by the clinician. The patient will only be approached about the ADAPT study if they decide they want to have apalutamide as part of their management.

The aims of the ADAPT study include documenting the biochemical effectiveness, as determined by the Prostate-Specific Antigen (PSA) and impact of apaluatmide on health related quality of life. The blood test for PSA is regularly monitored as standard of care.

Additionally, the impact of apalutamide on fatigue, cognitive function, patients reported outcomes, health related quality of life will be evaluated using patient questionnaires answered at defined timepoints. The questionnaires will be sent either electronically or via post at week 12, 24, 36, 48, 72 and 104 weeks after commencement of apalutamide.

Currently, the majority of data regarding tolerability and biochemical response to apalutamide has been from large phase III trials, where there are strict eligibility criteria. Real-world data as from the ADAPT study can provide valuable complementary data to randomised controlled trials, which can be used to address the 'generalizability' limitations of randomised control trials and can provide evidence on the external validity of their findings. This information can advance knowledge of patterns of care, treatment effectiveness and side-effects and inform clinical practice to improve outcomes.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

• Study Type: Observational
• Enrollment (Actual): 170

Contacts and Locations

Study Locations

• United Kingdom
  • Aylesbury, United Kingdom, HP21 8AL
    • Buckinghamshire Healthcare NHS Trust
  • Belfast, United Kingdom, BT9 7AB
    • Northern Ireland Cancer Centre, Belfast Health & Social Care Trust
  • Blackburn, United Kingdom, BB2 3HH
    • East Lancashire Hospitals NHS Trust
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
  • Cardiff, United Kingdom, CF14 2TL
    • Velindre Cancer Centre, Velindre University NHS Trust
  • Lancaster, United Kingdom, LA1 4RP
    • University Hospitals of Morecambe Bay NHS Foundation Trust
  • Liverpool, United Kingdom, CH63 4JY
    • Clatterbrdige Cancer Centre, NHS Foundation Trust
  • Middlesbrough, United Kingdom, TS4 3BW
    • The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
  • Newcastle, United Kingdom, NE7 7DN
    • Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Newcastle, United Kingdom, NE34 0PL
    • South Tyneside and Sunderland NHS Foundation Trust
  • Stockton-on-Tees, United Kingdom, TS19 8PE
    • The University Hospital of North Tees
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • The Royal Marsden Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Males 18 years of age or older, with metastatic hormone sensitive prostate cancer

Description

Inclusion Criteria:

• Male 18 years of age or older
• Histologically confirmed diagnosis of adenocarcinoma of the prostate with both:
• Metastatic hormone sensitive prostate cancer
• Treatment decision for apalutamide by clinician

Exclusion Criteria:

• Non-metastatic prostate cancer
• Prior chemotherapy / abiraterone / apalutamide / darolutamide / enzalutamide for prostate cancer
• Unable to complete patient reported outcome questionnaires

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with mHSPC and treatment decision for apalutamide by clinician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Undetectable PSA rate (defined as PSA <0.2ng/ml by end of year 1 and year 2) in mHSPC patients receiving apalutamide	August 2023 - April 2027

Secondary Outcome Measures

Outcome Measure	Time Frame
The impact of apalutamide on fatigue, assessed using patient-reported Brief Fatigue Inventory questionnaire	August 2023 - April 2027
The impact of apalutamide on cognitive function, using patient-reported FACT-Cog questionnaire	August 2023 - April 2027
The impact of apalutamide on health-related quality of life, using patient-reported EQ-5D-5L questionnaire	August 2023 - April 2027

Other Outcome Measures

Outcome Measure	Time Frame
Health care professional experience on the use of apalutamide, assessed using Health Care Professional Questionnaire	August 2023 - April 2027

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust
• Collaborators: Janssen, LP
• Investigators: Principal Investigator: Julia Murray, Dr., The Royal Marsden Hospital, NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Hypersensitivity; Prostatic Neoplasms
• Other Study ID Numbers: CCR5793

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No