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

Sponsor
Royal Marsden NHS Foundation Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06019676
Collaborator
Janssen, LP (Industry)
170
Enrollment
5
Locations
43
Anticipated Duration (Months)
34
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    170 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients, a Multicentre Prospective Observational Study
    Anticipated Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Apr 1, 2027
    Anticipated Study Completion Date :
    Apr 1, 2027

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with mHSPC and treatment decision for apalutamide by clinician

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. The impact of apalutamide on fatigue, assessed using patient-reported Brief Fatigue Inventory questionnaire [August 2023 - April 2027]

    2. The impact of apalutamide on cognitive function, using patient-reported FACT-Cog questionnaire [August 2023 - April 2027]

    3. The impact of apalutamide on health-related quality of life, using patient-reported EQ-5D-5L questionnaire [August 2023 - April 2027]

    Other Outcome Measures

    1. Health care professional experience on the use of apalutamide, assessed using Health Care Professional Questionnaire [August 2023 - April 2027]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Velindre Cancer Centre, Velindre University NHS Trust Cardiff United Kingdom CF14 2TL
    2 Clatterbrdige Cancer Centre, NHS Foundation Trust Liverpool United Kingdom CH63 4JY
    3 University College London Hospital, NHS Foundation Trust London United Kingdom NW1 2PG
    4 The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust Middlesbrough United Kingdom TS4 3BW
    5 The Rosemere Cancer Centre, Lancashire Teaching Hospitals NHS Foundation Trust Middlesbrough United Kingdom

    Sponsors and Collaborators

    • Royal Marsden NHS Foundation Trust
    • Janssen, LP

    Investigators

    • Principal Investigator: Julia Murray, Dr., The Royal Marsden Hospital, NHS Foundation Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Royal Marsden NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT06019676
    Other Study ID Numbers:
    • CCR5793
    First Posted:
    Aug 31, 2023
    Last Update Posted:
    Aug 31, 2023
    Last Verified:
    Aug 1, 2023
    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
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Hypersensitivity

    Study Results

    No Results Posted as of Aug 31, 2023