An observational study in Prostatic Neoplasms, sponsored by Janssen Inc.. Completed at 22 sites in Canada. Open to male participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2023-07-25.
Sponsored by Janssen Inc. · Observational
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 374 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Janssen Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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).
Other: Standard of Care
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.
Other: Standard of Care
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.
Other: Standard of Care
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.
Participants will not receive any intervention in this study. Participants will receive standard of care therapy.
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Approximately up to 5 years
Time from ADT Initiation to nmCRPC
Time from ADT initiation to nmCRPC will be reported.
Time frame: 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.
Time frame: 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.
Time frame: Approximately up to 5 years
Duration of Each Therapy
Duration for each therapy will be reported for all participants.
Time frame: 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.
Time frame: Approximately up to 5 years
Time to Treatment Initiation
Time to treatment initiation, will be reported for all participants.
Time frame: Approximately up to 5 years
Time to Dose Modification
Time to dose modification, will be reported for all participants.
Time frame: Approximately up to 5 years
Number of Participants who Switch the Treatment
Number of participants who switch the treatment, will be reported.
Time frame: Approximately up to 5 years
Number of Participants who Discontinued the Treatment
Number of participants who discontinued the treatment, will be reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Approximately up to 5 years
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Janssen Inc.