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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03501173
Recruitment Status : Active, not recruiting
First Posted : April 18, 2018
Last Update Posted : November 5, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Inc.

Tracking Information
First Submitted Date March 28, 2018
First Posted Date April 18, 2018
Last Update Posted Date November 5, 2021
Actual Study Start Date April 12, 2018
Estimated Primary Completion Date July 7, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 3, 2021)
  • Time to Prostate Specific Antigen (PSA) Progression [ Time Frame: Approximately up to 5 years ]
    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.
  • Time to Radiographic Evidence of Disease Progression [ Time Frame: Approximately up to 5 years ]
    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).
  • Time to Skeletal-Related Events [ Time Frame: Approximately up to 5 years ]
    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.
  • Time to Death [ Time Frame: Approximately up to 5 years ]
    Time to death is defined as the time interval from the date of start of study enrollment to death.
  • Number of Participants with Different Primary Causes of Death [ Time Frame: Approximately up to 5 years ]
    The number of participants with different primary causes of death will be reported.
  • Time to Progression from mCSPC to mCRPC in Participants with mCSPC [ Time Frame: Approximately up to 5 years ]
    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.
  • Time from Biochemical Recurrence (BCR) to Nonmetastatic Castrate-Resistant Prostate Cancer (nmCRPC) and nmCRPC to mCRPC [ Time Frame: Approximately up to 5 years ]
    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.
  • Number of Participants with PSA Testing from BCR to nmCRPC and nmCRPC to mCRPC, in Participants with mCRPC [ Time Frame: Approximately up to 5 years ]
    In participants with mCRPC, number of participants having PSA testing from BCR to nmCRPC and nmCRPC to mCRPC will be reported.
  • Number of Participants with Frequency of Imaging from Time of BCR to nmCRPC and nmCRPC to mCRPC [ Time Frame: Approximately up to 5 years ]
    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.
  • PSA Level at Start of Androgen Deprivation Therapy (ADT) in Participants with mCRPC [ Time Frame: Approximately up to 5 years ]
    In participants with mCRPC, PSA level at start of ADT will be reported.
  • PSA Doubling Time (PSADT) at the Detection of Castration Resistance in Participants with mCRPC [ Time Frame: Approximately up to 5 years ]
    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.
  • Time from nmCRPC to High-Risk (HR) nmCRPC [ Time Frame: Approximately up to 5 years ]
    Time from nmCRPC to HR nmCRPC is defined as prostate specific antigen doubling time (PSADT) less than or equal to (<=) 10 months.
  • Time from ADT Initiation to nmCRPC [ Time Frame: Approximately up to 5 years ]
    Time from ADT initiation to nmCRPC will be reported.
  • Median Absolute prostate specific antigen (PSA) at onset of HR-nmCRPC [ Time Frame: Approximately up to 5 years ]
    Median absolute PSA at onset of HR-nmCRPC will be reported.
  • Time to Initiation of Subsequent Prostate Cancer Treatment [ Time Frame: Approximately up to 5 years ]
    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.
  • Duration of Each Therapy [ Time Frame: Approximately up to 5 years ]
    Duration for each therapy will be reported for all participants.
  • Percentage of Participants Receiving Chemotherapy, Other Drug Treatments, or no Drug Treatment [ Time Frame: Approximately up to 5 years ]
    Percentage of participants receiving chemotherapy, other drug treatments, or no drug treatment, will be reported for all participants.
  • Time to Treatment Initiation [ Time Frame: Approximately up to 5 years ]
    Time to treatment initiation, will be reported for all participants.
  • Time to Dose Modification [ Time Frame: Approximately up to 5 years ]
    Time to dose modification, will be reported for all participants.
  • Number of Participants who Switch the Treatment [ Time Frame: Approximately up to 5 years ]
    Number of participants who switch the treatment, will be reported.
  • Number of Participants who Discontinued the Treatment [ Time Frame: Approximately up to 5 years ]
    Number of participants who discontinued the treatment, will be reported.
  • Most Common Sequences for Lines of Therapy in Participants with mCRPC [ Time Frame: Approximately up to 5 years ]
    In participants with mCRPC, most common sequences for lines of therapy will be reported.
  • Number of Participants Retreated with Docetaxel in Participants with mCRPC [ Time Frame: Approximately up to 5 years ]
    In participants with mCRPC, number of participants having retreatment with docetaxel will be reported.
  • Percentage of Participant with Radiographic Imaging Modality [ Time Frame: Approximately up to 5 years ]
    Percentage of participants with radiographic imaging modality which includes bone scan, magnetic resonance imaging, ultrasound, X-ray will be reported.
  • Number of Days Hospitalized for Prostate Cancer or Treatment of Prostate Cancer [ Time Frame: Approximately up to 5 years ]
    Number of days for which participant was hospitalized for prostate cancer or treatment of prostate cancer, will be reported for all participants.
  • Number of Visits to Emergency Department for Prostate Cancer or Treatment of Prostate Cancer [ Time Frame: Approximately up to 5 years ]
    Number of visits to emergency department for prostate cancer or treatment of prostate cancer, will be reported for all participants.
  • Number of Outpatient Visits to Specialists Involved in Management of Prostate Cancer [ Time Frame: Approximately up to 5 years ]
    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.
  • Dates of Genomic or Genetic Testing [ Time Frame: Approximately up to 5 years ]
    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.
  • Types of Genomic or Genetic Testing [ Time Frame: Approximately up to 5 years ]
    Types of genomic or genetic testing (including DRD/HRR/ BRCA1/ BRCA2/ATM /PALB2/AR) will be reported.
  • Charlson Comorbidity Index Score [ Time Frame: Approximately up to 5 years ]
    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.
Original Primary Outcome Measures
 (submitted: April 16, 2018)
  • Time to Prostate Specific Antigen (PSA) Progression [ Time Frame: Approximately up to 3 years ]
    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.
  • Time to Radiographic Evidence of Disease Progression [ Time Frame: Approximately up to 3 years ]
    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).
  • Time to Skeletal-Related Events [ Time Frame: Approximately up to 3 years ]
    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.
  • Time to Death [ Time Frame: Approximately up to 3 years ]
    Time to death is defined as the time interval from the date of start of study enrollment to death.
  • Number of Participants with Different Primary Causes of Death [ Time Frame: Approximately up to 3 years ]
    The number of participants with different primary causes of death will be reported.
  • Time to Progression from mCSPC to mCRPC in Participants with mCSPC [ Time Frame: Approximately up to 3 years ]
    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.
  • Time from Biochemical Recurrence (BCR) to Nonmetastatic Castrate-Resistant Prostate Cancer (nmCRPC) and nmCRPC to mCRPC [ Time Frame: Approximately up to 3 years ]
    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.
  • Number of Participants with PSA Testing from BCR to nmCRPC and nmCRPC to mCRPC, in Participants with mCRPC [ Time Frame: Approximately up to 3 years ]
    In participants with mCRPC, number of participants having PSA testing from BCR to nmCRPC and nmCRPC to mCRPC will be reported.
  • PSA Level at Start of Androgen Deprivation Therapy (ADT) in Participants with mCRPC [ Time Frame: Approximately up to 3 years ]
    In participants with mCRPC, PSA level at start of ADT will be reported.
  • PSA Doubling Time (PSAdt) at the Detection of Castration Resistance in Participants with mCRPC [ Time Frame: Approximately up to 3 years ]
    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.
  • Time to Initiation of Subsequent Prostate Cancer Treatment [ Time Frame: Approximately up to 3 years ]
    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.
  • Duration of Each Therapy [ Time Frame: Approximately up to 3 years ]
    Duration for each therapy will be reported for all participants.
  • Percentage of Participants Receiving Chemotherapy, Other Drug Treatments, or no Drug Treatment [ Time Frame: Approximately up to 3 years ]
    Percentage of participants receiving chemotherapy, other drug treatments, or no drug treatment, will be reported for all participants.
  • Time to Treatment Initiation [ Time Frame: Approximately up to 3 years ]
    Time to treatment initiation, will be reported for all participants.
  • Time to Dose Modification [ Time Frame: Approximately up to 3 years ]
    Time to dose modification, will be reported for all participants.
  • Number of Participants who Switch the Treatment [ Time Frame: Approximately up to 3 years ]
    Number of participants who switch the treatment, will be reported.
  • Number of Participants who Discontinued the Treatment [ Time Frame: Approximately up to 3 years ]
    Number of participants who discontinued the treatment, will be reported.
  • Most Common Sequences for Lines of Therapy in Participants with mCRPC [ Time Frame: Approximately up to 3 years ]
    In participants with mCRPC, most common sequences for lines of therapy will be reported.
  • Number of Participants Retreated with Docetaxel in Participants with mCRPC [ Time Frame: Approximately up to 3 years ]
    In participants with mCRPC, number of participants having retreatment with docetaxel will be reported.
  • Percentage of Participant with Radiographic Imaging Modality [ Time Frame: Approximately up to 3 years ]
    Percentage of participants with radiographic imaging modality which includes bone scan, magnetic resonance imaging, ultrasound, X-ray will be reported.
  • Number of Days Hospitalized for Prostate Cancer or Treatment of Prostate Cancer [ Time Frame: Approximately up to 3 years ]
    Number of days for which participant was hospitalized for prostate cancer or treatment of prostate cancer, will be reported for all participants.
  • Number of Visits to Emergency Department for Prostate Cancer or Treatment of Prostate Cancer [ Time Frame: Approximately up to 3 years ]
    Number of visits to emergency department for prostate cancer or treatment of prostate cancer, will be reported for all participants.
  • Number of Outpatient Visits to Specialists Involved in Management of Prostate Cancer [ Time Frame: Approximately up to 3 years ]
    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.
  • Charlson Comorbidity Index Score [ Time Frame: Approximately up to 3 years ]
    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.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study of Participants With Advanced Prostate Cancer in Canada
Official Title A Multicentre Cohort Study of Patients With Advanced Prostate Cancer in Canada
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Prostatic Neoplasms
Intervention Other: Standard of Care
Participants will not receive any intervention in this study. Participants will receive standard of care therapy.
Study Groups/Cohorts
  • 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).
    Intervention: Other: Standard of Care
  • 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.
    Intervention: Other: Standard of Care
  • 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.
    Intervention: Other: Standard of Care
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: October 14, 2021)
379
Original Estimated Enrollment
 (submitted: April 16, 2018)
200
Estimated Study Completion Date July 7, 2023
Estimated Primary Completion Date July 7, 2023   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Male
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03501173
Other Study ID Numbers CR108454
212082PCR4049 ( Other Identifier: Janssen Inc. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Janssen Inc.
Study Sponsor Janssen Inc.
Collaborators Not Provided
Investigators
Study Director: Janssen Inc. Clinical Trial Janssen Inc.
PRS Account Janssen Inc.
Verification Date November 2021