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

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ClinicalTrials.gov Identifier: NCT03501173
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Inc.

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.

Condition or disease Intervention/treatment
Prostatic Neoplasms Other: Standard of Care

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicentre Cohort Study of Patients With Advanced Prostate Cancer in Canada
Actual Study Start Date : April 12, 2018
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 3 months, documented metastatic prostate cancer, no more than 12 months of androgen deprivation therapy (ADT) and no more than 3 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}]), and 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.




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Duration of Each Therapy [ Time Frame: Approximately up to 3 years ]
    Duration for each therapy will be reported for all participants.

  13. 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.

  14. Time to Treatment Initiation [ Time Frame: Approximately up to 3 years ]
    Time to treatment initiation, will be reported for all participants.

  15. Time to Dose Modification [ Time Frame: Approximately up to 3 years ]
    Time to dose modification, will be reported for all participants.

  16. Number of Participants who Switch the Treatment [ Time Frame: Approximately up to 3 years ]
    Number of participants who switch the treatment, will be reported.

  17. Number of Participants who Discontinued the Treatment [ Time Frame: Approximately up to 3 years ]
    Number of participants who discontinued the treatment, will be reported.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
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]) will be enrolled in this study.
Criteria

Inclusion Criteria:

  • Participant must have a confirmed diagnosis of adenocarcinoma of the prostate
  • Participant must have metastatic prostate cancer, as follows: a) Metastatic castrate-sensitive prostate cancer (mCSPC): new mCSPC diagnosis in the past 3 months, documented metastatic prostate cancer, no more than 12 months of androgen deprivation therapy (ADT), no more than 3 months of systemic treatment for mCSPC (example, next generation androgen receptor targeted therapy or chemotherapy), b) 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 nano moles per liter{nmol/L}]), the first treatment for mCRPC was started in the past 6 months or is scheduled to begin
  • 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, participant is currently enrolled in an investigational clinical study for prostate cancer
  • Participant is currently enrolled in an observational study sponsored or managed by a Janssen company

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501173


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Canada, Alberta
Prostate Cancer Centre Recruiting
Calgary, Alberta, Canada, T2V 1P9
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Abbotsford Regional Hospital and Cancer Centre BC Cancer Agency Recruiting
Abbotsford, British Columbia, Canada, V2S 0C2
Vancouver General Hospital / Vancouver Prostate Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
BC Cancer Agency - Vancouver BC Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
Cancer Care Manitoba Not yet recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
Queen Elizabeth II - Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Research St. Joseph's - Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Hamilton Health Sciences Corporation Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Lawson Health Research Institute Recruiting
London, Ontario, Canada, N6A 5W9
Credit Valley Hospital Not yet recruiting
Mississauga, Ontario, Canada, L5M 2V8
The Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Urology South Shore Research Recruiting
Greenfield Park, Quebec, Canada, J4V 2H3
CHUM - Centre hospitalier universitaire de Montreal Recruiting
Montreal, Quebec, Canada, H2X 0A9
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Canada
CHU de Québec Université Laval Not yet recruiting
Quebec, Canada, G1R 2J6
Sponsors and Collaborators
Janssen Inc.
Investigators
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Study Director: Janssen Inc. Clinical Trial Janssen Inc.

Additional Information:
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Responsible Party: Janssen Inc.
ClinicalTrials.gov Identifier: NCT03501173     History of Changes
Other Study ID Numbers: CR108454
212082PCR4049 ( Other Identifier: Janssen Inc. )
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases