A Study of Participants With Advanced Prostate Cancer in Canada (GURC)

J

Janssen (J&J Innovative Medicine)

Status

Completed

Conditions

Prostatic Neoplasms

Treatments

Other: Standard of Care

Study type

Observational

Funder types

Industry

Identifiers

NCT03501173
CR108454
212082PCR4049 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to document the course of advanced prostate cancer in Canada in terms of disease progression, real-world treatment, and patient management.

Enrollment

374 patients

Sex

Male

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participant must have a confirmed diagnosis of adenocarcinoma of the prostate
  • Participant must have prostate cancer, as follows: a) nonmetastatic castrate-resistant prostate cancer (nmCRPC): nmCRPC diagnosis at any time; documented castration resistance per Prostate Cancer Working Group 3 criteria23 (elevated prostate specific antigen [PSA] despite testosterone less than (<) 50 nanograms per deciliter [ng/dL] [<1.7 nano moles per liter {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 nmol/L]); the first treatment for mCRPC was started in the past 6 months or is scheduled to begin; d) mCRPC (treatment-experienced in the nmCRPC or mCSPC setting): mCRPC diagnosis at any time; documented metastatic prostate cancer; documented castration resistance per Prostate Cancer Working Group 2 criteria (elevated PSA despite testosterone <50 ng/dL [<1.7 nmol/L]); the first treatment for mCRPC clinical state was started in the past 6 months or is scheduled to begin; disease progression occurred while receiving active treatment (androgen receptor-axis therapy [ARAT] or chemotherapy) in the prior nmCRPC or mCSPC clinical state
  • 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

Trial design

374 participants in 4 patient groups

Metastatic Castrate-Sensitive Prostate Cancer (mCSPC)
Description:
Participants will be defined as having mCSPC if there is a new mCSPC diagnosis in the past 6 months, documented metastatic prostate cancer, no more than 12 months of androgen deprivation therapy (ADT) in any setting and no more than 6 months of systemic treatment for mCSPC (example, next generation androgen receptor targeted therapy or chemotherapy).
Treatment:
Other: Standard of Care
Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
Description:
Participants will be defined as having mCRPC if there is 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.
Treatment:
Other: Standard of Care
NonMetastatic Castrate-Resistant Prostate Cancer (nmCRPC)
Description:
Participants will be defined as having nmCRPC if there is nmCRPC diagnosis at any time, documented non-metastatic prostate cancer, documented castration resistance per Prostate Cancer Working Group 3 criteria (elevated PSA despite testosterone <50 ng/dL [<1.7 nmol/L]). nmCRPC, defined as a prostate specific antigen doubling time (PSADT) of less than or equal to 12 months, or beginning next generation ARAT for nmCRPC.
Treatment:
Other: Standard of Care
mCRPC (Treatment-experienced in the nmCRPC or mCSPC Setting)
Description:
Participants will be defined as having mCRPC (treatment-experienced in the nmCRPC or mCSPC setting) if there is nmCRPC diagnosis at any time, documented non-metastatic prostate cancer, documented metastatic prostate cancer, documented castration resistance per Prostate Cancer Working Group 2 criteria (elevated PSA despite testosterone <50 ng/dL [<1.7nmol/L]), the first treatment for mCRPC clinical state was started in the past 6months or is scheduled to begin, disease progression occurred while receiving active treatment (ARAT or chemotherapy) in the prior nmCRPC or mCSPC clinical state.

Trial contacts and locations

22

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Data sourced from clinicaltrials.gov

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