Prostate Cancer Clinical Trial
Official title:
A Prospective Registry of Patients With a Confirmed Diagnosis of Adenocarcinoma of the Prostate Presenting With Metastatic Castrate-Resistant Prostate Cancer
Verified date | November 2019 |
Source | Janssen Pharmaceutica N.V., Belgium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this registry is to document the characteristics and management of patients with metastatic castrate resistant prostate cancer (mCRPC) in routine clinical practice, independent of treatment used. Given the rapidly evolving landscape in mCRPC treatments, there is a need for a current and improved understanding of how these treatments fit into the current treatment paradigm for mCRPC, how they are combined and sequenced, and how their relative effectiveness profiles emerge outside of a clinical trial setting. This will be based on documentation and description of sequencing of treatment initiation, termination, and duration; relative effectiveness of treatments; defined medical resource utilization (MRU) and quality-of-life parameters and follow-up for survival.
Status | Completed |
Enrollment | 3050 |
Est. completion date | November 21, 2018 |
Est. primary completion date | November 21, 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 Exclusion Criteria: Any patient who is withdrawn from the registry for any reason may not re-enter the registry |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen Pharmaceutica N.V., Belgium |
Austria, Belgium, France, Germany, Israel, Luxembourg, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sequencing of treatment initiation, termination, and duration | During the registry all systemic mCRPC therapies, corticoids for systemic use in the context of prostate cancer treatment and local mCRPC therapies, including but not limited to urologic surgery, orthopaedic surgery, and local radiotherapy, will be documented. | At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years | |
Secondary | Clinical Benefit | Clinical benefit will be based on the Eastern Cooperative Oncology Group (ECOG) performance status, which measure the patient status on a scale from 0 (fully active) to 5 (dead). | At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years | |
Secondary | Medical Resource Utilization | Total number of days of hospitalization due to prostate cancer, or treatment of the disease, total number of visits to an emergency room due to prostate cancer, or treatment of the disease, and total number of outpatient visits due to prostate cancer, or treatment of the disease | At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years | |
Secondary | European Quality of Life-5 Dimensions, 5 Levels Questionnaire (EQ-5D-(5L)) | The EQ-5D-5L is an instrument for measuring health status. It consists of the descriptive system and the EQ visual Analogue scale (EQ VAS). The descriptive system comprises the same 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). There are 5 levels for each dimension: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. | At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years | |
Secondary | Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) | The FACT-P consists of the FACT-General (FACT-G) and a prostate cancer subscale. The FACT-G (Version 4) contains a 27-item questionnaire and is composed of 4 subscales of health-related quality-of-life: physical well-being, social/family well-being, emotional well being, and functional well-being. The prostate cancer subscale is composed of 12 items, related to prostate-specific questions, which include sexuality, bowel/bladder function, and pain. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to 156; a higher score indicates better QOL | At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years | |
Secondary | Overall Survival | At treatment initiation/termination or every 3 months from baseline to 3 years | ||
Secondary | Radiologic Assessment | Radiologic assessment methodology and radiologic response will be documented. Prostate Cancer Working Group 2 (PCWG2) and Response Evaluation Criteria In Solid Tumor (RECIST) are recommended guidelines for assessment. | At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years | |
Secondary | Prior prostate cancer treatment | Prior prostate cancer treatment (local and systemic therapy) from the time of diagnosis of prostate cancer to entry in the registry will be recorded. | At baseline | |
Secondary | Reason for start and rationale for choice of treatment | At treatment initiation during maximum 3 years | ||
Secondary | Reason for treatment discontinuation | At treatment discontinuation during maximum 3 years |
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