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

Janssen (J&J Innovative Medicine)

Status: Active, not recruiting

Conditions: Metastatic Hormone-sensitive Prostate Cancer

Treatments: Drug: Apalutamide; Drug: Enzalutamide

Study type: Observational

Funder types: Industry

Identifiers

NCT05901649

56021927PCR4031 (Other Identifier)

CR109320

Details and patient eligibility

About

The purpose of this study is to assess the real-world outcomes differences between apalutamide or enzalutamide plus androgen deprivation therapy (ADT) for the treatment of participants with metastatic hormone-sensitive prostate cancer (mHSPC).

Enrollment: 503 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

503 participants in 2 patient groups

Apalutamide Plus Androgen Deprivation Therapy (ADT)

Description:

Participants with metastatic hormone-sensitive prostate cancer (mHSPC) will be observed who are being treated with apalutamide under clinical practice setting. Only data available per routine clinical practice will be collected within this study.

Treatment:

Drug: Apalutamide

Enzalutamide Plus Androgen Deprivation Therapy (ADT)

Description:

Participants with metastatic hormone-sensitive prostate cancer (mHSPC) will be observed who are being treated with enzalutamide under clinical practice setting. Only data available per routine clinical practice will be collected within this study.

Treatment:

Drug: Enzalutamide