A Study of Participants With Advanced Prostate Cancer in Canada

Prostatic Neoplasms Clinical Trial

— GURC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03501173
• Other study ID #: CR108454
• Secondary ID: 212082PCR4049
• Status: Completed
• Start date: April 12, 2018
• Est. completion date: July 14, 2023

Study information

• Verified date: July 2023
• Source: Janssen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: July 14, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Other:
• Standard of Care
Participants will not receive any intervention in this study. Participants will receive standard of care therapy.

Locations

Country	Name	City	State
Canada	Abbotsford Regional Hospital and Cancer Centre BC Cancer Agency	Abbotsford	British Columbia
Canada	G. Kenneth Jansz Medicine	Burlington	Ontario
Canada	Prostate Cancer Centre	Calgary	Alberta
Canada	Tom Baker Cancer Center	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Urology South Shore Research	Greenfield Park	Quebec
Canada	Queen Elizabeth II - Health Sciences Centre	Halifax	Nova Scotia
Canada	Hamilton Health Sciences Corporation	Hamilton	Ontario
Canada	Research St. Joseph's - Hamilton	Hamilton	Ontario
Canada	British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI)	Kelowna	British Columbia
Canada	Lawson Health Research Institute	London	Ontario
Canada	Credit Valley Hospital	Mississauga	Ontario
Canada	CHUM - Centre hospitalier universitaire de Montreal	Montreal	Quebec
Canada	Jewish General Hospital	Montreal	Quebec
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario
Canada	CHU de Québec Université Laval	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Scarborough Health Network	Toronto	Ontario
Canada	BC Cancer Agency - Vancouver BC	Vancouver	British Columbia
Canada	Vancouver General Hospital / Vancouver Prostate Centre	Vancouver	British Columbia
Canada	British Columbia Cancer Agency - Vancouver Island Centre	Victoria	British Columbia
Canada	Cancer Care Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Time from ADT Initiation to nmCRPC	Time from ADT initiation to nmCRPC will be reported.	Approximately up to 5 years
Primary	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
Primary	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
Primary	Duration of Each Therapy	Duration for each therapy will be reported for all participants.	Approximately up to 5 years
Primary	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
Primary	Time to Treatment Initiation	Time to treatment initiation, will be reported for all participants.	Approximately up to 5 years
Primary	Time to Dose Modification	Time to dose modification, will be reported for all participants.	Approximately up to 5 years
Primary	Number of Participants who Switch the Treatment	Number of participants who switch the treatment, will be reported.	Approximately up to 5 years
Primary	Number of Participants who Discontinued the Treatment	Number of participants who discontinued the treatment, will be reported.	Approximately up to 5 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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