Prostatic NeoplasmsGURCNCT03501173
A Study of Participants With Advanced Prostate Cancer in Canada
An observational study of Prostatic Neoplasms, run by Janssen Inc. at 22 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- How many people
- 374 participants
- Where
- 22 sitesCanada
- Study dates
- 12 Apr 2018to 14 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Canada22 sites
Abbotsford Regional Hospital and Cancer Centre BC Cancer Agency
Abbotsford British Columbia, British Columbia, V2S 0C2
G. Kenneth Jansz Medicine
Burlington, Ontario, L7N 3V2
Tom Baker Cancer Center
Calgary, Alberta, T2N 4N2
Prostate Cancer Centre
Calgary, Alberta, T2V 1P9
University of Alberta
Edmonton, Alberta, T6G 1Z2
Urology South Shore Research
Greenfield Park, Quebec, J4V 2H3
Queen Elizabeth II - Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Research St. Joseph's - Hamilton
Hamilton, Ontario, L8N 4A6
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8V 5C2
British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI)
Kelowna, British Columbia, V1Y 5L3
Lawson Health Research Institute
London, Ontario, N6A 5W9
Credit Valley Hospital
Mississauga, Ontario, L5M 2V8
CHUM - Centre hospitalier universitaire de Montreal
Montreal, Quebec, H2X 0A9
Jewish General Hospital
Montreal, Quebec, H3T 1E2
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
CHU de Québec Université Laval
Québec, Quebec, G1R 2J6
Scarborough Health Network
Toronto, Ontario, M1VOE3
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Vancouver General Hospital / Vancouver Prostate Centre
Vancouver, British Columbia, V5Z 1M9
BC Cancer Agency - Vancouver BC
Vancouver, British Columbia, V5Z 4E6
British Columbia Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, V8R 6V5
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: 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.
- Conditions
- Prostatic Neoplasms
- Being tested
- Standard of Care
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Participants will not receive any intervention in this study. Participants will receive standard of care therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately up to 5 years
Time from ADT Initiation to nmCRPC
Time from ADT initiation to nmCRPC will be reported.
Measured: 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.
Measured: 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.
Measured: Approximately up to 5 years
Duration of Each Therapy
Duration for each therapy will be reported for all participants.
Measured: 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.
Measured: Approximately up to 5 years
Time to Treatment Initiation
Time to treatment initiation, will be reported for all participants.
Measured: Approximately up to 5 years
Time to Dose Modification
Time to dose modification, will be reported for all participants.
Measured: Approximately up to 5 years
Number of Participants who Switch the Treatment
Number of participants who switch the treatment, will be reported.
Measured: Approximately up to 5 years
Number of Participants who Discontinued the Treatment
Number of participants who discontinued the treatment, will be reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start12 Apr 2018
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Inc. Clinical Trial, Study director, Janssen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501173
- Sponsor's protocol ID
- CR108454
- Other IDs
- 212082PCR4049
- Acronym
- GURC
- Status last verified
- Jul 2023
- First submitted
- 28 Mar 2018
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Cohort Study of Patients With Advanced Prostate Cancer in Canada
- ClinicalTrials.gov ID
- NCT03501173
- Acronym / sponsor ID
- GURC / CR108454
- Conditions
- Prostatic Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Janssen Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Metastatic Castrate-Sensitive Prostate Cancer (mCSPC) | – | Other: Standard of CareParticipants 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) | – | Other: Standard of CareParticipants 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) | – | Other: Standard of CareParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareParticipants will not receive any intervention in this study. Participants will receive standard of care therapy. | Other | Metastatic Castrate-Resistant Prostate Cancer (mCRPC), Metastatic Castrate-Sensitive Prostate Cancer (mCSPC), NonMetastatic Castrate-Resistant Prostate Cancer (nmCRPC) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Inc. Clinical Trial study director
Janssen Inc.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms, run by Janssen Inc. at 22 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Prostate Specific Antigen (PSA) Progression (time frame: Approximately up to 5 years). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.