A Study of Participants With Advanced Prostate Cancer in Canada
NCT ID: NCT03501173
Last Updated: 2023-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
374 participants
OBSERVATIONAL
2018-04-12
2023-07-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Registry of Participants With Prostate Cancer in Asia
NCT02546908
Safety and Efficacy Study of Hypofractionated Radiotherapy and Androgen Deprivation Therapy for Prostate Cancer
NCT01505075
Prospective Prostate Cancer and Patient-reported Outcomes Registry
NCT04694924
PSMA-Guided Ablation of the Prostate
NCT06003556
Multi-modality Prostate Cancer Image Guided Interventions
NCT04009174
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Metastatic Castrate-Sensitive Prostate Cancer (mCSPC)
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).
Standard of Care
Participants will not receive any intervention in this study. Participants will receive standard of care therapy.
Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
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.
Standard of Care
Participants will not receive any intervention in this study. Participants will receive standard of care therapy.
NonMetastatic Castrate-Resistant Prostate Cancer (nmCRPC)
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.
Standard of Care
Participants will not receive any intervention in this study. Participants will receive standard of care therapy.
mCRPC (Treatment-experienced in the nmCRPC or mCSPC Setting)
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standard of Care
Participants will not receive any intervention in this study. Participants will receive standard of care therapy.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Participant is currently enrolled in any observational study sponsored or managed by a Janssen company
21 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen Inc. Clinical Trial
Role: STUDY_DIRECTOR
Janssen Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tom Baker Cancer Center
Calgary, Alberta, Canada
Prostate Cancer Centre
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Abbotsford Regional Hospital and Cancer Centre BC Cancer Agency
Abbotsford, British Columbia, Canada
British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI)
Kelowna, British Columbia, Canada
Vancouver General Hospital / Vancouver Prostate Centre
Vancouver, British Columbia, Canada
BC Cancer Agency - Vancouver BC
Vancouver, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, Canada
Queen Elizabeth II - Health Sciences Centre
Halifax, Nova Scotia, Canada
G. Kenneth Jansz Medicine
Burlington, Ontario, Canada
Research St. Joseph's - Hamilton
Hamilton, Ontario, Canada
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada
Lawson Health Research Institute
London, Ontario, Canada
Credit Valley Hospital
Mississauga, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Scarborough Health Network
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Urology South Shore Research
Greenfield Park, Quebec, Canada
CHUM - Centre hospitalier universitaire de Montreal
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
CHU de Québec Université Laval
Québec, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
212082PCR4049
Identifier Type: OTHER
Identifier Source: secondary_id
CR108454
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.