A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide

Official record

Identifier

NCT05901649

Recruiting locations

countries

AustriaFranceGermanyGreeceSpainUnited Kingdom

Interventions studied

ApalutamideEnzalutamide

Lead sponsor

Janssen-Cilag Ltd.

Target enrolment

505 participants

Study type

OBSERVATIONAL

Phase

Not provided in the official record

Status

Completed

First posted

Jun 13, 2023

Last updated on the registry

Jul 31, 2026

Age

18 Years

Sex

MALE

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* Must have a histologically or cytologically-confirmed diagnosis of adenocarcinoma of the prostate
* Must have documented metastatic hormone-sensitive prostate cancer (mHSPC)
* Must have agreed with the treating physician the initiation of either apalutamide or enzalutamide (plus androgen deprivation therapy \[ADT\]) treatment, per the treating physician's decision, prior to enrollment into the study
* Must sign, and/or their legally acceptable representative where applicable must sign, a participation agreement/ informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
* Must have baseline prostate-specific antigen (PSA) captured within 30 days prior to the first administration of apalutamide or enzalutamide
* Must agree to complete patient-reported outcomes (PROs) during the study, including the baseline ones collected before the first administration of apalutamide or enzalutamide

Exclusion Criteria:

* Has already received or is currently receiving either apalutamide or enzalutamide, or any other novel hormonal treatments (including but not limited to abiraterone acetate and darolutamide)
* Is currently receiving an active treatment for prostate cancer as part of an interventional study
* Has a progression under ADT treatment (and thus became castrate-resistant) prior to start of apalutamide or enzalutamide treatment
* Has received ADT treatment for mHSPC for more than 2 months prior to apalutamide or enzalutamide treatment initiation or ADT treatment was administered for earlier disease stages within the last 12 months prior to apalutamide or enzalutamide treatment initiation
* Has received prior docetaxel for the treatment of mHSPC
* Participants is not treated in line with current Summary of Product Characteristics for apalutamide or enzalutamide