NCT06019676ACTIVE_NOT_RECRUITING

Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients

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

Sponsor: Royal Marsden NHS Foundation Trust + Janssen, LP

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Key Facts

Study type

OBSERVATIONAL

Conditions

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Interventions

—

Enrollment

170 participants

Primary completion

Apr 2027

Study completion

Apr 2027

First posted

Aug 2023

Last updated

Sep 2025

Primary Endpoints (CT.gov)

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

Secondary Endpoints

The impact of apalutamide on fatigue, assessed using patient-reported Brief Fatigue Inventory questionnaire

The impact of apalutamide on cognitive function, using patient-reported FACT-Cog questionnaire

The impact of apalutamide on health-related quality of life, using patient-reported EQ-5D-5L questionnaire

Eligibility Criteria

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

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov