Clinical trial · Observational
A Study of Participants With Advanced Prostate Cancer in Canada
A Multicentre Cohort Study of Patients With Advanced Prostate Cancer in Canada
NCT03501173CI-TRIAL-00068233GURCcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- 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).
- interventionNames
- Other: Standard of Care
- label
- 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.
- interventionNames
- Other: Standard of Care
- label
- NonMetastatic Castrate-Resistant Prostate Cancer (nmCRPC)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
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 companyReferences
Publications (0)
Data not yet available
No reference posted for this study.