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

November 7, 2019 updated by: Janssen Pharmaceutica N.V., Belgium

A Prospective Registry of Patients With a Confirmed Diagnosis of Adenocarcinoma of the Prostate Presenting With Metastatic Castrate-Resistant Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

3050

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria
      • Vienna, Austria
  • Belgium
      • Aalst, Belgium
      • Antwerpen, Belgium
      • Bonheiden, Belgium
      • Brasschaat, Belgium
      • Brugge, Belgium
      • Edegem, Belgium
      • Gent, Belgium
      • Kortrijk, Belgium
      • Liège, Belgium
      • Oostende, Belgium
      • Ottignies, Belgium
      • Roeselare, Belgium
      • Turnhout, Belgium
  • France
      • Angers, France
      • Avignon Cedex 9, France
      • Brest, France
      • Béziers, France
      • GAP, France
      • Hyeres, France
      • La Tronche, France
      • Marseille, France
      • Metz, France
      • Montpellier, France
      • Nancy, France
      • Paris, France
      • Perigueux, France
      • Pierre Benite Cedex, France
      • Pringy, France
      • Reims Cedex, France
      • Rennes cedex 09, France
      • Saint Mande, France
      • St Gregoire Cedex, France
      • St Quentin Cedex, France
      • Toulouse, France
      • Tours Cedex, France
  • Germany
      • Augsburg, Germany
      • Bad Saarow, Germany
      • Bautzen, Germany
      • Berlin, Germany
      • Braunschweig, Germany
      • Chemnitz, Germany
      • Duisburg, Germany
      • Erkrath, Germany
      • Frankfurt, Germany
      • Hamburg, Germany
      • Holzminden, Germany
      • Jena, Germany
      • Kiel, Germany
      • Kirchheim, Germany
      • Nürtingen, Germany
      • Remscheid, Germany
      • Reutlingen, Germany
      • Rostock, Germany
      • Schwerin, Germany
      • Sindelfingen, Germany
      • Tübingen, Germany
      • Ulm, Germany
      • Weiden, Germany
      • Wilhelmshaven, Germany
      • Würselen, Germany
  • Israel
      • Beer Sheva, Israel
      • Beer Yaakov, Israel
      • Haifa, Israel
      • Holon, Israel
      • Tel-Aviv, Israel
  • Luxembourg
      • Luxembourg, Luxembourg
      • Niederkorn, Luxembourg
  • Poland
      • Bydgoszcz, Poland
      • Gdynia, Poland
      • Krakow, Poland
      • Lodz, Poland
      • Opole, Poland
      • Poznañ, Poland
      • Warsaw, Poland
      • Warszawa, Poland
  • Portugal
      • Braga, Portugal
      • Coimbra, Portugal
      • Evora, Portugal
      • Lisboa, Portugal
      • Porto, Portugal
      • Setubal, Portugal
  • Russian Federation
      • Ekaterinbourg, Russian Federation
      • Moscow N/a, Russian Federation
      • Obninsk, Russian Federation
      • Omsk, Russian Federation
      • Rostov-on-Don, Russian Federation
      • St.-Petersburg, Russian Federation
      • Ufa, Russian Federation
  • Slovenia
      • Celje, Slovenia
      • Ljubljana, Slovenia
      • Slovenj Gradec, Slovenia
  • Spain
      • Asturias, Spain
      • Barakaldo Vizcaya, Spain
      • Barcelona, Spain
      • Bilbao Vizcaya, Spain
      • Girona, Spain
      • La Coruña, Spain
      • Langreo, Spain
      • Palma De Mallorca, Spain
      • Pontevedra, Spain
      • Sabadell, Spain
      • Salamanca, Spain
      • Santiago de Compostela, Spain
      • Valladolid, Spain
      • Zaragoza, Spain
  • Sweden
      • Borås, Sweden
      • Göteborg, Sweden
      • Malmö, Sweden
      • Stockholm, Sweden
      • Umeå, Sweden
      • Västerås, Sweden
      • Växjö, Sweden
      • Örebro, Sweden
      • Östersund, Sweden
  • Switzerland
      • Aarau, Switzerland
      • Winterthur, Switzerland
  • Turkey
      • Ankara, Turkey
      • Edirne, Turkey
      • Istanbul, Turkey
      • Izmir, Turkey
      • Kayseri, Turkey
      • Kocaeli, Turkey
      • Turkey, Turkey
  • United Kingdom
      • Ashton Under Lyne, United Kingdom
      • Barnstaple, United Kingdom
      • Blackburn, United Kingdom
      • Bournemouth, United Kingdom
      • Bradford, United Kingdom
      • Brighton Sussex, United Kingdom
      • Burton, United Kingdom
      • Crewe, United Kingdom
      • Huddersfield, United Kingdom
      • Lancaster, United Kingdom
      • Leeds Yorks, United Kingdom
      • London, United Kingdom
      • N/a N/a, United Kingdom
      • Plymouth, United Kingdom
      • Scunthorpe, United Kingdom
      • Steeton, United Kingdom
      • Stoke On Trent, United Kingdom
      • Taunton, United Kingdom
      • Torquay, United Kingdom
      • Wakefield, United Kingdom
      • Wigan, United Kingdom
      • York, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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
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
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
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
At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Overall Survival
Time Frame: At treatment initiation/termination or every 3 months from baseline to 3 years
At treatment initiation/termination or every 3 months from baseline to 3 years
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.
At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
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.
At baseline
Reason for start and rationale for choice of treatment
Time Frame: At treatment initiation during maximum 3 years
At treatment initiation during maximum 3 years
Reason for treatment discontinuation
Time Frame: At treatment discontinuation during maximum 3 years
At treatment discontinuation during maximum 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Pharmaceutica N.V., Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2013

Primary Completion (Actual)

November 21, 2018

Study Completion (Actual)

November 21, 2018

Study Registration Dates

First Submitted

September 8, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (Estimate)

September 10, 2014

Study Record Updates

Last Update Posted (Actual)

November 12, 2019

Last Update Submitted That Met QC Criteria

November 7, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR100857
  • 212082PCR4001 (Other Identifier: Janssen Pharmaceutica NV - CTMS ID)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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