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

October 11, 2023 updated by: Royal Marsden NHS Foundation Trust

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

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Not yet recruiting
        • Northern Ireland Cancer Centre, Belfast Health & Social Care Trust
        • Contact:
        • Principal Investigator:
          • Laura Feeney, Dr.
      • Cambridge, United Kingdom, CB2 0QQ
        • Not yet recruiting
        • Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Danish Mazhar, Dr.
      • Cardiff, United Kingdom, CF14 2TL
        • Not yet recruiting
        • Velindre Cancer Centre, Velindre University NHS Trust
        • Contact:
        • Principal Investigator:
          • Elin S Evans, Dr.
      • Liverpool, United Kingdom, CH63 4JY
        • Not yet recruiting
        • Clatterbrdige Cancer Centre, NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Isabel Syndikus, Prof.
      • London, United Kingdom, NW1 2PG
        • Not yet recruiting
        • University College London Hospital, NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Reena Davda, Dr.
      • Middlesbrough, United Kingdom, TS4 3BW
        • Not yet recruiting
        • The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Darren Leaning, Dr.
      • Middlesbrough, United Kingdom
        • Not yet recruiting
        • The Rosemere Cancer Centre, Lancashire Teaching Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Omi Parikh, Dr.
      • Newcastle, United Kingdom, NE7 7DN
        • Not yet recruiting
        • Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Rachel Pearson, Dr.
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • The Royal Marsden Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Julia Murray, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: August 2023 - April 2027
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
Time Frame: August 2023 - April 2027
August 2023 - April 2027
The impact of apalutamide on cognitive function, using patient-reported FACT-Cog questionnaire
Time Frame: August 2023 - April 2027
August 2023 - April 2027
The impact of apalutamide on health-related quality of life, using patient-reported EQ-5D-5L questionnaire
Time Frame: August 2023 - April 2027
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
Time Frame: August 2023 - April 2027
August 2023 - April 2027

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR5793

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe