Eligibility Details:
Inclusion Criteria:
- Participant must have a confirmed diagnosis of adenocarcinoma of the prostate
- Participant must have metastatic prostate cancer, as follows: a) nmCRPC: nmCRPC
diagnosis at any time, documented castration resistance per Prostate Cancer Working
Group 3 criteria23 (elevated PSA despite testosterone <50 ng/dL [<1.7 nmol/L]),
Negative for metastases on conventional imaging (computerized tomography, Magnetic
resonance imaging, bone scans), Prostate specific antigen doubling time (PSADT) less
than equal to (<=) 12 months within the last 6 months or beginning treatment with
approved next-generation ARAT for treatment of nmCRPC b) Metastatic castrate-sensitive
prostate cancer (mCSPC): new mCSPC diagnosis in the past 6 months (can be de novo or
primary progressive recurrent following local radical therapy), documented metastatic
prostate cancer, no more than 12 months of androgen deprivation therapy (ADT) in any
setting, no more than 6 months of systemic treatment for mCSPC (example, approved next
generation androgen receptor targeted therapy or chemotherapy]), c) Metastatic
castrate-resistant prostate cancer (mCRPC): mCRPC diagnosis at any time, documented
metastatic prostate cancer, documented castration resistance per Prostate Cancer
Working Group 2 criteria (elevated prostate specific antigen [PSA] despite
testosterone less than [<]50 nanogram per deciliter [ng/dL] [<1.7 nano moles per
liter{nmol/L}]), the first treatment for mCRPC was started in the past 6 months or is
scheduled to begin
- Participant must have a life expectancy of more than 6 months
- Participant must sign (and/or their legally acceptable representative, if applicable)
a participation agreement/informed consent form (ICF) allowing data collection and
source data verification in accordance with local requirements and/or sponsor policy
Exclusion Criteria:
- At the time of screening, patient is currently enrolled in other Janssen sponsored
clinical study (any indication) or an interventional clinical trial investigating a
non Health Canada approved drug and/or procedure for the treatment and/or monitoring
of prostate cancer (Janssen or non-Janssen company sponsored)
- Participant is currently enrolled in any observational study sponsored or managed by a
Janssen company