A Study of Participants With Advanced Prostate Cancer in Canada

NCT03501173 | Completed

• 2 other identifiers: CR108454212082PCR4049
• Study Type: observational
• Target: 374
• Locations: 1 country
• Sites: 22

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.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (30)

• 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.

  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

Study Arms (4)

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).

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.

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.

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.

Interventions

Standard of Care OTHER

Participants will not receive any intervention in this study. Participants will receive standard of care therapy.

Metastatic Castrate-Resistant Prostate Cancer (mCRPC); Metastatic Castrate-Sensitive Prostate Cancer (mCSPC); NonMetastatic Castrate-Resistant Prostate Cancer (nmCRPC)

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Inc.: lead

Study Sites (22)

Tom Baker Cancer Center

Calgary, Alberta, T2N 4N2, Canada

Location

Prostate Cancer Centre

Calgary, Alberta, T2V 1P9, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 1Z2, Canada

Location

Abbotsford Regional Hospital and Cancer Centre BC Cancer Agency

Abbotsford, British Columbia, V2S 0C2, Canada

Location

British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI)

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Vancouver General Hospital / Vancouver Prostate Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

BC Cancer Agency - Vancouver BC

Vancouver, British Columbia, V5Z 4E6, Canada

Location

British Columbia Cancer Agency - Vancouver Island Centre

Victoria, British Columbia, V8R 6V5, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Queen Elizabeth II - Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

G. Kenneth Jansz Medicine

Burlington, Ontario, L7N 3V2, Canada

Location

Research St. Joseph's - Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Hamilton Health Sciences Corporation

Hamilton, Ontario, L8V 5C2, Canada

Location

Lawson Health Research Institute

London, Ontario, N6A 5W9, Canada

Location

Credit Valley Hospital

Mississauga, Ontario, L5M 2V8, Canada

Location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Scarborough Health Network

Toronto, Ontario, M1VOE3, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Urology South Shore Research

Greenfield Park, Quebec, J4V 2H3, Canada

Location

CHUM - Centre hospitalier universitaire de Montreal

Montreal, Quebec, H2X 0A9, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

CHU de Québec Université Laval

Québec, Quebec, G1R 2J6, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Janssen Inc. Clinical Trial

  Janssen Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 18, 2018
• Study Start: April 12, 2018
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

CA (22)