A Registry to Observe the Treatment of Prostate Cancer Under Routine Medical Care

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02236637
• Date of registration: 08/09/2014
• Prospective Registration: No
• Primary sponsor: Janssen Pharmaceutica N.V., Belgium
• Public title: A Registry to Observe the Treatment of Prostate Cancer Under Routine Medical Care
• Scientific title: A Prospective Registry of Patients With a Confirmed Diagnosis of Adenocarcinoma of the Prostate Presenting With Metastatic Castrate-Resistant Prostate Cancer
• Date of first enrolment: June 14, 2013
• Target sample size: 3050
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02236637
• Study type: Observational

Countries of recruitment

Austria, Belgium, France, Germany, Israel, Italy, Luxembourg, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom

Key inclusion & exclusion criteria

Inclusion Criteria:

Patients with a histologically or cytologically confirmed diagnosis of adenocarcinoma of
the prostate Patients with documented metastatic prostate cancer Patients with documented
castration resistance Patients either: Initiating a new systemic mCRPC treatment; or
considered to be in surveillance according to clinical practice Sign (or their
legally-acceptable representatives must sign) a participation agreement or informed consent
form (ICF), per local regulations.

Exclusion Criteria:

Any patient who is withdrawn from the registry for any reason may not re-enter the registry



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Primary Outcome(s)

Sequencing of treatment initiation, termination, and duration [Time Frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years]

Secondary Outcome(s)

Medical Resource Utilization [Time Frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years]

Clinical Benefit [Time Frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years]

European Quality of Life-5 Dimensions, 5 Levels Questionnaire (EQ-5D-(5L)) [Time Frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years]

Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) [Time Frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years]

Prior prostate cancer treatment [Time Frame: At baseline]

Radiologic Assessment [Time Frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years]

Reason for start and rationale for choice of treatment [Time Frame: At treatment initiation during maximum 3 years]

Overall Survival [Time Frame: At treatment initiation/termination or every 3 months from baseline to 3 years]

Reason for treatment discontinuation [Time Frame: At treatment discontinuation during maximum 3 years]

Secondary ID(s)

CR100857

212082PCR4001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors