Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 212082PCR4049 | Other Identifier | Janssen Inc. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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. |
| |
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care | Other | Participants will not receive any intervention in this study. Participants will receive standard of care therapy. |
|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Inc. Clinical Trial | Janssen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Baker Cancer Center | Calgary | Alberta | T2N 4N2 | Canada | ||
| Prostate Cancer Centre |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Calgary |
| Alberta |
| T2V 1P9 |
| Canada |
| University of Alberta | Edmonton | Alberta | T6G 1Z2 | Canada |
| Abbotsford Regional Hospital and Cancer Centre BC Cancer Agency | Abbotsford British Columbia | British Columbia | V2S 0C2 | Canada |
| British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI) | Kelowna | British Columbia | V1Y 5L3 | Canada |
| Vancouver General Hospital / Vancouver Prostate Centre | Vancouver | British Columbia | V5Z 1M9 | Canada |
| BC Cancer Agency - Vancouver BC | Vancouver | British Columbia | V5Z 4E6 | Canada |
| British Columbia Cancer Agency - Vancouver Island Centre | Victoria | British Columbia | V8R 6V5 | Canada |
| Cancer Care Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Queen Elizabeth II - Health Sciences Centre | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| G. Kenneth Jansz Medicine | Burlington | Ontario | L7N 3V2 | Canada |
| Research St. Joseph's - Hamilton | Hamilton | Ontario | L8N 4A6 | Canada |
| Hamilton Health Sciences Corporation | Hamilton | Ontario | L8V 5C2 | Canada |
| Lawson Health Research Institute | London | Ontario | N6A 5W9 | Canada |
| Credit Valley Hospital | Mississauga | Ontario | L5M 2V8 | Canada |
| The Ottawa Hospital Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada |
| Scarborough Health Network | Toronto | Ontario | M1VOE3 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Urology South Shore Research | Greenfield Park | Quebec | J4V 2H3 | Canada |
| CHUM - Centre hospitalier universitaire de Montreal | Montreal | Quebec | H2X 0A9 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| CHU de Québec Université Laval | Québec | Quebec | G1R 2J6 | Canada |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |