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Trial record 1 of 1 for:    212082PCR4001
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A Registry to Observe the Treatment of Prostate Cancer Under Routine Medical Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02236637
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium

Brief Summary:
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.

Condition or disease
Prostate Cancer

Detailed Description:
This is a non-interventional, multicenter, prospective registry of patients with a confirmed diagnosis of adenocarcinoma of the prostate presenting with mCRPC, based on documented metastatic prostate cancer and documented castration resistance. Castrate-resistant prostate cancer is defined by disease progression despite testosterone <50 ng/dL, and/or androgen deprivation therapy, and/or a history of orchiectomy, and may present as a continuous rise in prostate-specific antigen (PSA), and/or worsening of existing disease/symptoms, and/or the appearance of new metastases. Observational methodology will be used to capture data. The decision of patients to take part in the registry will not influence their medical care. Treatment decisions will be made at the discretion of the treating physician, per routine clinical practice. Only data available from routine clinical practice will be collected. It is expected that approximately 3,000 patients will participate in this registry. To ensure a patient population representative of clinical practice and to reduce selection bias, all patients meeting the eligibility criteria at a participating site should be consecutively enrolled in the registry, irrespective of their treatment. The planned total duration of the registry will be 5.5 years from the date that the first patient is enrolled, irrespective of the country or registry site. The anticipated duration of patient enrollment is 2.5 years. The maximum duration of follow-up for individual patients in the observational period of the registry will be 3 years, regardless of when they are enrolled. The 3-year period of the observational period will document the sequencing of systemic mCRPC treatments during routine clinical practice, considering the life expectancy of patients with mCRPC in the registry. Unless specified otherwise per local regulations, all patients must give their informed consent to participate in this registry before data collection (ie, data entry into the case report form [CRF]) is performed. Patients will be enrolled at the time of initiation of a new systemic mCRPC treatment or during a period when a patient is considered to be in surveillance according to clinical practice. Baseline data collection will include details of the patient's prostate cancer history and prior prostate cancer treatment. This will be followed by a prospective observational period during which patients may cycle through multiple systemic mCRPC treatment periods and periods of surveillance. During the observational period, data will be collected at the following time points of a patient's course of treatment in routine clinical practice: initiation of a new systemic mCRPC treatment; termination of a systemic mCRPC treatment; when the duration of a systemic mCRPC treatment or surveillance period is >3 months, data collection will be performed at a minimum frequency of 3-monthly intervals during that period. Survival data will be collected for all patients 3 years after their enrollment or at the close of the registry, whichever occurs first, except for those patients who withdraw their consent prior to completing the observation period.

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Study Type : Observational
Actual Enrollment : 3050 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Registry of Patients With a Confirmed Diagnosis of Adenocarcinoma of the Prostate Presenting With Metastatic Castrate-Resistant Prostate Cancer
Actual Study Start Date : June 14, 2013
Actual Primary Completion Date : November 21, 2018
Actual Study Completion Date : November 21, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort
mCRPC patients
Patients with metastatic castration-resistant prostate cancer treated according to routine clinical practice



Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Clinical Benefit [ Time Frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years ]
    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).

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

  3. 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 ]
    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'.

  4. 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 ]
    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

  5. Overall Survival [ Time Frame: At treatment initiation/termination or every 3 months from baseline to 3 years ]
  6. Radiologic Assessment [ Time Frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years ]
    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.

  7. Prior prostate cancer treatment [ Time Frame: At baseline ]
    Prior prostate cancer treatment (local and systemic therapy) from the time of diagnosis of prostate cancer to entry in the registry will be recorded.

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Approximately 3,000 patients will be enrolled in this registry. Patients eligible for enrollment will be men aged at least 18 years, with a confirmed diagnosis of adenocarcinoma of the prostate, with documented metastatic prostate cancer and documented castration resistance. Patients will be enrolled at the time of initiating a new systemic anticancer mCRPC treatment or during surveillance; for the purpose of the registry, at enrollment, initiation of a new systemic mCRPC treatment is considered as ±30 days from a patient's baseline data collection.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236637


Locations
Show Show 147 study locations
Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium

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Responsible Party: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier: NCT02236637    
Other Study ID Numbers: CR100857
212082PCR4001 ( Other Identifier: Janssen Pharmaceutica NV - CTMS ID )
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Pharmaceutica N.V., Belgium:
Adenocarcinoma of the Prostate
Registry
metastatic castration-resistant prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases