Clinical trial NCT03501173: A Study of Participants With Advanced Prostate Cancer in Canada
Official title: A Multicentre Cohort Study of Patients With Advanced Prostate Cancer in Canada
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Lead sponsor: Janssen Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-18
Enrollment: 374
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participant having advanced prostate cancer (metastatic castrate-sensitive prostate cancer \[mCSPC\] or metastatic castrate-resistant prostate cancer \[mCRPC\] or nonmetastatic castrate-resistant prostate cancer \[nmCRPC\]) or mCRPC (treatment-experienced in the nmCRPC or mCSPC setting) will be enrolled in this study.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to Prostate Specific Antigen (PSA) Progression
timeFrame: Approximately up to 5 years
measure: Time to Radiographic Evidence of Disease Progression
timeFrame: Approximately up to 5 years
measure: Time to Skeletal-Related Events
timeFrame: Approximately up to 5 years
measure: Time to Death
timeFrame: Approximately up to 5 years
measure: Number of Participants with Different Primary Causes of Death
timeFrame: Approximately up to 5 years
measure: Time to Progression from mCSPC to mCRPC in Participants with mCSPC
timeFrame: Approximately up to 5 years
measure: Time from Biochemical Recurrence (BCR) to Nonmetastatic Castrate-Resistant Prostate Cancer (nmCRPC) and nmCRPC to mCRPC
timeFrame: Approximately up to 5 years
measure: Number of Participants with PSA Testing from BCR to nmCRPC and nmCRPC to mCRPC, in Participants with mCRPC
timeFrame: Approximately up to 5 years
measure: Number of Participants with Frequency of Imaging from Time of BCR to nmCRPC and nmCRPC to mCRPC
timeFrame: Approximately up to 5 years
measure: PSA Level at Start of Androgen Deprivation Therapy (ADT) in Participants with mCRPC
timeFrame: Approximately up to 5 years
measure: PSA Doubling Time (PSADT) at the Detection of Castration Resistance in Participants with mCRPC
timeFrame: Approximately up to 5 years
measure: Time from nmCRPC to High-Risk (HR) nmCRPC
timeFrame: Approximately up to 5 years
measure: Time from ADT Initiation to nmCRPC
timeFrame: Approximately up to 5 years
measure: Median Absolute prostate specific antigen (PSA) at onset of HR-nmCRPC
timeFrame: Approximately up to 5 years
measure: Time to Initiation of Subsequent Prostate Cancer Treatment
timeFrame: Approximately up to 5 years
measure: Duration of Each Therapy
timeFrame: Approximately up to 5 years
measure: Percentage of Participants Receiving Chemotherapy, Other Drug Treatments, or no Drug Treatment
timeFrame: Approximately up to 5 years
measure: Time to Treatment Initiation
timeFrame: Approximately up to 5 years
measure: Time to Dose Modification
timeFrame: Approximately up to 5 years
measure: Number of Participants who Switch the Treatment
timeFrame: Approximately up to 5 years
measure: Number of Participants who Discontinued the Treatment
timeFrame: Approximately up to 5 years
measure: Most Common Sequences for Lines of Therapy in Participants with mCRPC
timeFrame: Approximately up to 5 years
measure: Number of Participants Retreated with Docetaxel in Participants with mCRPC
timeFrame: Approximately up to 5 years
measure: Percentage of Participant with Radiographic Imaging Modality
timeFrame: Approximately up to 5 years
measure: Number of Days Hospitalized for Prostate Cancer or Treatment of Prostate Cancer
timeFrame: Approximately up to 5 years
measure: Number of Visits to Emergency Department for Prostate Cancer or Treatment of Prostate Cancer
timeFrame: Approximately up to 5 years
measure: Number of Outpatient Visits to Specialists Involved in Management of Prostate Cancer
timeFrame: Approximately up to 5 years
measure: Dates of Genomic or Genetic Testing
timeFrame: Approximately up to 5 years
measure: Types of Genomic or Genetic Testing
timeFrame: Approximately up to 5 years
measure: Charlson Comorbidity Index Score
timeFrame: Approximately up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: Calgary
country: Canada
facility: Prostate Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Abbotsford
country: Canada
facility: Abbotsford Regional Hospital and Cancer Centre BC Cancer Agency
state: British Columbia
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI)
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital / Vancouver Prostate Centre
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer Agency - Vancouver BC
state: British Columbia
city: Victoria
country: Canada
facility: British Columbia Cancer Agency - Vancouver Island Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II - Health Sciences Centre
state: Nova Scotia
city: Burlington
country: Canada
facility: G. Kenneth Jansz Medicine
state: Ontario
city: Hamilton
country: Canada
facility: Research St. Joseph's - Hamilton
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corporation
state: Ontario
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Scarborough Health Network
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Greenfield Park
country: Canada
facility: Urology South Shore Research
state: Quebec
city: Montreal
country: Canada
facility: CHUM - Centre hospitalier universitaire de Montreal
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Quebec
country: Canada
facility: CHU de Québec Université Laval
Study officials:
affiliation: Janssen Inc.
name: Janssen Inc. Clinical Trial
role: STUDY_DIRECTOR
References: