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

A Multicentre Cohort Study of Patients With Advanced Prostate Cancer in Canada

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Other: Standard of Care

• Study Type: Observational
• Enrollment (Actual): 374

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1R 2J6
    • CHU de Quebec Universite Laval
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Center
    • Calgary, Alberta, Canada, T2V 1P9
      • Prostate Cancer Centre
    • Edmonton, Alberta, Canada, T6G 1Z2
      • University of Alberta
  • British Columbia
    • Abbotsford, British Columbia, Canada, V2S 0C2
      • Abbotsford Regional Hospital and Cancer Centre BC Cancer Agency
    • Kelowna, British Columbia, Canada, V1Y 5L3
      • British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI)
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital / Vancouver Prostate Centre
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • BC Cancer Agency - Vancouver BC
    • Victoria, British Columbia, Canada, V8R 6V5
      • British Columbia Cancer Agency - Vancouver Island Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Cancer Care Manitoba
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Queen Elizabeth II - Health Sciences Centre
  • Ontario
    • Burlington, Ontario, Canada, L7N 3V2
      • G. Kenneth Jansz Medicine
    • Hamilton, Ontario, Canada, L8N 4A6
      • Research St. Joseph's - Hamilton
    • Hamilton, Ontario, Canada, L8V 5C2
      • Hamilton Health Sciences Corporation
    • London, Ontario, Canada, N6A 5W9
      • Lawson Health Research Institute
    • Mississauga, Ontario, Canada, L5M 2V8
      • Credit Valley Hospital
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital Cancer Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital
    • Toronto, Ontario, Canada, M1VOE3
      • Scarborough Health Network
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H3
      • Urology South Shore Research
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
    • Montreal, Quebec, Canada, H2X 0A9
      • CHUM - Centre hospitalier universitaire de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Other: 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.	Other: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Prostate Specific Antigen (PSA) Progression	Time to PSA progression is defined as the time interval from the date of start of study enrollment to the date of first evidence of PSA progression. In participants whose PSA level has decreased, PSA progression is defined as at least a 25 percent (%) increase from nadir (lowest value including the most recent value prior to study enrollment) and an increase in the absolute value of 2 nanogram per milliliter (ng/mL) or greater, confirmed by a subsequent measurement at least 3 weeks after the increase. In participants whose PSA level has not decreased, PSA progression is defined as at least a 25% increase from the most recent value prior to study enrollment and an increase in the absolute value of 2 ng/mL or greater after 12 weeks.	Approximately up to 5 years
Time to Radiographic Evidence of Disease Progression	Time to radiographic evidence of disease progression is defined as the time interval from the date of start of study treatment to the date of first appearance of 2 or more new bone lesions on bone scan or enlargement of a soft tissue lesion using the Response Evaluation Criteria in Solid Tumors (RECIST).	Approximately up to 5 years
Time to Skeletal-Related Events	Time to skeletal-related events is defined as the time interval from the date of start of study treatment to the date of first skeletal-related event.	Approximately up to 5 years
Time to Death	Time to death is defined as the time interval from the date of start of study enrollment to death.	Approximately up to 5 years
Number of Participants with Different Primary Causes of Death	The number of participants with different primary causes of death will be reported.	Approximately up to 5 years
Time to Progression from mCSPC to mCRPC in Participants with mCSPC	In participants with mCSPC, time to progression from mCSPC to mCRPC is defined as the time interval which is either calculated from date when mCSPC was first documented or from the date of start of study treatment, if participant receives treatment for mCSPC to the progression to mCRPC.	Approximately up to 5 years
Time from Biochemical Recurrence (BCR) to Nonmetastatic Castrate-Resistant Prostate Cancer (nmCRPC) and nmCRPC to mCRPC	In participants with mCRPC, time from BCR to nmCRPC and nmCRPC to mCRPC will be analyzed retrospectively. BCR is defined as PSA greater than (>)0.2 nanogram per milliliter (ng/mL) after radical prostatectomy and PSA >2 ng/mL above the nadir (lowest value including the most recent value prior to study enrollment) after radical radiotherapy.	Approximately up to 5 years
Number of Participants with PSA Testing from BCR to nmCRPC and nmCRPC to mCRPC, in Participants with mCRPC	In participants with mCRPC, number of participants having PSA testing from BCR to nmCRPC and nmCRPC to mCRPC will be reported.	Approximately up to 5 years
Number of Participants with Frequency of Imaging from Time of BCR to nmCRPC and nmCRPC to mCRPC	In participants with non metastatic castrateresistant prostate cancer (nmCRPC), number of participants having imaging from BCR to nmCRPC and mCRPC to nmCRPC will be reported.	Approximately up to 5 years
PSA Level at Start of Androgen Deprivation Therapy (ADT) in Participants with mCRPC	In participants with mCRPC, PSA level at start of ADT will be reported.	Approximately up to 5 years
PSA Doubling Time (PSADT) at the Detection of Castration Resistance in Participants with mCRPC	In participants with mCRPC, PSADT at the detection of castration resistance will be reported. PSADT is the length of time it takes for a PSA to double based on an exponential growth pattern.	Approximately up to 5 years
Time from nmCRPC to High-Risk (HR) nmCRPC	Time from nmCRPC to HR nmCRPC is defined as prostate specific antigen doubling time (PSADT) less than or equal to (<=) 10 months.	Approximately up to 5 years
Time from ADT Initiation to nmCRPC	Time from ADT initiation to nmCRPC will be reported.	Approximately up to 5 years
Median Absolute prostate specific antigen (PSA) at onset of HR-nmCRPC	Median absolute PSA at onset of HR-nmCRPC will be reported.	Approximately up to 5 years
Time to Initiation of Subsequent Prostate Cancer Treatment	Time to initiation of subsequent prostate cancer treatment is defined as the time interval from the date of start of study treatment to the date of start of subsequent prostate cancer treatment.	Approximately up to 5 years
Duration of Each Therapy	Duration for each therapy will be reported for all participants.	Approximately up to 5 years
Percentage of Participants Receiving Chemotherapy, Other Drug Treatments, or no Drug Treatment	Percentage of participants receiving chemotherapy, other drug treatments, or no drug treatment, will be reported for all participants.	Approximately up to 5 years
Time to Treatment Initiation	Time to treatment initiation, will be reported for all participants.	Approximately up to 5 years
Time to Dose Modification	Time to dose modification, will be reported for all participants.	Approximately up to 5 years
Number of Participants who Switch the Treatment	Number of participants who switch the treatment, will be reported.	Approximately up to 5 years
Number of Participants who Discontinued the Treatment	Number of participants who discontinued the treatment, will be reported.	Approximately up to 5 years
Most Common Sequences for Lines of Therapy in Participants with mCRPC	In participants with mCRPC, most common sequences for lines of therapy will be reported.	Approximately up to 5 years
Number of Participants Retreated with Docetaxel in Participants with mCRPC	In participants with mCRPC, number of participants having retreatment with docetaxel will be reported.	Approximately up to 5 years
Percentage of Participant with Radiographic Imaging Modality	Percentage of participants with radiographic imaging modality which includes bone scan, magnetic resonance imaging, ultrasound, X-ray will be reported.	Approximately up to 5 years
Number of Days Hospitalized for Prostate Cancer or Treatment of Prostate Cancer	Number of days for which participant was hospitalized for prostate cancer or treatment of prostate cancer, will be reported for all participants.	Approximately up to 5 years
Number of Visits to Emergency Department for Prostate Cancer or Treatment of Prostate Cancer	Number of visits to emergency department for prostate cancer or treatment of prostate cancer, will be reported for all participants.	Approximately up to 5 years
Number of Outpatient Visits to Specialists Involved in Management of Prostate Cancer	Number of outpatient visits to specialists (urologist, medical oncologist, uro-oncologist, radiation oncologist) involved in management of prostate cancer, will be reported for all participants.	Approximately up to 5 years
Dates of Genomic or Genetic Testing	Dates of genomic or genetic testing (including dopa-responsive dystonia [DRD]/ homologous recombination repair [HRR]/ breast cancer gene-1 [BRCA1]/ BRCA2/ataxia-telangiesctasia mutated [ATM]/partner and localizer of the BRCA2 gene [PALB2]/ androgen receptor [AR]) will be reported.	Approximately up to 5 years
Types of Genomic or Genetic Testing	Types of genomic or genetic testing (including DRD/HRR/ BRCA1/ BRCA2/ATM /PALB2/AR) will be reported.	Approximately up to 5 years
Charlson Comorbidity Index Score	Charlson Comorbidity Index score will be summarized descriptively. The Charlson Comorbidity Index is a 19-item measure assessing comorbid conditions. The total possible score on the Charlson Comorbidity Index ranges from 0 to 37. If a condition is not present, the score for that condition is zero. The higher scores indicate greater comorbidity.	Approximately up to 5 years

Collaborators and Investigators

• Sponsor: Janssen Inc.
• Investigators: Study Director: Janssen Inc. Clinical Trial, Janssen Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2018
• Primary Completion (Actual): July 14, 2023
• Study Completion (Actual): July 14, 2023

Study Registration Dates

• First Submitted: March 28, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CR108454; 212082PCR4049 (Other Identifier: Janssen Inc.)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No