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Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients

NCT06019676 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 170

Last updated 2025-09-18

No results posted yet for this study

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.

Conditions

  • Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Julia Murray, Dr. · The Royal Marsden Hospital, NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-26
Primary Completion
2027-04-01
Completion
2027-04-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06019676 on ClinicalTrials.gov