PROCARE - PROstate Cancer Real World Evidence Registry
PROCARE
PROstate CAncer Real World Evidence Registry: RECURRENT AND METASTATIC PROSTATE CANCER
3 other identifiers
observational
5,000
1 country
53
Brief Summary
The aim of this registry study with long-term follow-up is to record the course of therapy and disease in patients with recurrent and metastatic prostate cancer. The following patient groups are planned:
- Patients with a recurrence of PSA after surgical removal or radiation of the prostate due to prostate cancer; so-called PSA recurrence (relapse) or biochemical recurrence.
- Patients with a PSA recurrence who have received treatment by hormone deprivation therapy (so-called androgen deprivation) and in whom the PSA value has nevertheless risen again without spreading to other organs or parts of the body, so-called non-metastatic castration-resistant prostate cancer.
- Patients with proven spread to other organs or parts of the body (= metastases, e.g. in the bone) without hormone deprivation therapy having been initiated, so-called metastatic hormone-sensitive prostate cancer.
- Patients with prostate cancer and spread to other organs or parts of the body (= metastases) in whom the tumor disease has progressed despite hormone withdrawal treatment (e.g. as evidenced by an increase in PSA), so-called metastatic castration-refractory prostate cancer. These four groups of patients are enrolled and observed independently of each other at different time periods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2024
Longer than P75 for all trials
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 29, 2024
CompletedFirst Submitted
Initial submission to the registry
February 6, 2025
CompletedFirst Posted
Study publicly available on registry
February 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2032
March 12, 2026
March 1, 2026
7.2 years
February 6, 2025
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Therapy Frequencies and Patterns of Therapy
Description of therapy frequencies and patterns in routine clinical practice for the included patient cohorts
Through study completion, an average of 7 years
Secondary Outcomes (19)
Annual (vs. cumulative) Patterns of Disease Management
Through study completion, an average of 7 years
Methodology for Disease Status Assessment
Through study completion, an average of 7 years
Frequency for Disease Status Assessment
Through study completion, an average of 7 years
Drug Effectiveness Depending on Prior Treatment
Through study completion, an average of 7 years
Parameters Affecting Prognosis
Through study completion, an average of 7 years
- +14 more secondary outcomes
Study Arms (4)
Cohort 1: biochemical recurrence (BCR) after local curative intended treatment
Cohort 2: non-metastatic castration-resistant prostate cancer (nmCRPC)
Cohort 3: metastatic hormone-sensitive prostate cancer (mHSPC)
Cohort 4: metastatic castration-resistant prostate cancer (mCRCP)
Eligibility Criteria
Adult prostate cancer patients (age ≥18 years) who will receive a new line of systemic therapy at the time of study entry or up to 4 weeks thereafter.
You may qualify if:
- Adult prostate cancer patients (age ≥18 years).
- Patients who will receive a new line of systemic therapy at the time of study entry or up to 4 weeks thereafter. Regarding Cohort 4 this includes patients with a new diagnosis of mCRPC (=first line mCRPC) after either treatment for mHSPC or non-metastatic CRPC as well as patients with prior mCRPC treatments (2nd, 3rd, … line).
- For Cohorts 1, 2 and 3: Disease proven by clinical measures (i.e. standard imaging) to be either unsuitable for local salvage treatment (e.g. surgery, radiotherapy) or local treatment is declined by the patient.
- Patients, who are able and willing to sign the informed consent form
You may not qualify if:
- Patients who are not eligible for observation due to severe comorbidities or unavailability according to the treating physician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UroTrials Company (GmbH)lead
- Novartis Pharmaceuticalscollaborator
- AstraZenecacollaborator
Study Sites (53)
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
National Center for Tumor Dieseases (NCT) Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
University Hospital Mannheim
Mannheim, Baden-Wurttemberg, 68167, Germany
Medical Office for Urology Nürtingen
Nürtingen, Baden-Wurttemberg, 72622, Germany
Studienpraxis Urologie
Nürtingen, Baden-Wurttemberg, 72622, Germany
University Hospital Tübingen
Tübingen, Baden-Wurttemberg, 72076, Germany
University Hospital Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
University Hospital Augsburg
Augsburg, Bavaria, 86156, Germany
University Hospital Augsburg
Augsburg, Bavaria, 86156, Germany
Hospital Bayreuth GmbH
Bayreuth, Bavaria, 95445, Germany
University Hospital Erlangen
Erlangen, Bavaria, 91054, Germany
Hospital Kempten
Kempten (Allgäu), Bavaria, 87439, Germany
Hospital Nürnberg North
Nuremberg, Bavaria, 90419, Germany
Caritas-Hospital St. Josef
Regensburg, Bavaria, 93053, Germany
University Hospital Würzburg
Würzburg, Bavaria, 97080, Germany
"Vivantes Prostatazentrum" Hospital "am Urban"
Berlin, Brandenburg, 10967, Germany
University Hospital Hamburg-Eppendorf
Hamburg, Hamburg, 20246, Germany
University Hospital Frankfurt/Main
Frankfurt am Main, Hesse, 60590, Germany
Universitiy Hospital Gießen und Marburg GmbH, Site: Gießen
Giessen, Hesse, 35392, Germany
Universital Hospital Gießen & Marburg GmbH, Site: Marburg
Marburg, Hesse, 35043, Germany
Hospital Wetzlar
Wetzlar, Hesse, 35578, Germany
Medical Office for Urology
Braunschweig, Lower Saxony, 38100, Germany
Medical Office for Urology
Herzberg am Harz, Lower Saxony, 37412, Germany
St. Bernward Hospital Hildesheim
Hildesheim, Lower Saxony, 31134, Germany
St. Bernward Krankenhaus GmbH
Hildesheim, Lower Saxony, 31134, Germany
Medical Office for Urology Altstadtquartier Magdeburg
Magdeburg, Lower Saxony, 39104, Germany
MVZ Onco Medical GmbH Neustadt
Neustadt am Rübenberge, Lower Saxony, 31535, Germany
Praxisgemeinschaft f. Onkologie & Urologie
Wilhelmshaven, Lower Saxony, 26389, Germany
University Hospital Rostock
Rostock, Mecklenburg-Vorpommern, 18057, Germany
University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
Medical Office for Urology
Bayenthal, North Rhine-Westphalia, 50968, Germany
Marien Hospital Bergisch Gladbach,
Bergisch Gladbach, North Rhine-Westphalia, 51465, Germany
Johanniter GmbH, Johanniterkrankenhaus
Bonn, North Rhine-Westphalia, 53113, Germany
Johanniter Hosptal Bonn
Bonn, North Rhine-Westphalia, 53113, Germany
University Hospital Bonn
Bonn, North Rhine-Westphalia, 53127, Germany
Medical Office for Urology "Urologicum"
Duisburg, North Rhine-Westphalia, 47169, Germany
University Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225, Germany
University Hospital Essen
Essen, North Rhine-Westphalia, 45147, Germany
Marien Hospital Herne, University Hospital der Ruhr-Universität Bochum
Herne, North Rhine-Westphalia, 44625, Germany
"Brüder" Hospital St. Joseph Paderborn
Paderborn, North Rhine-Westphalia, 33098, Germany
University Hospital Wuppertal
Wuppertal, North Rhine-Westphalia, 42283, Germany
Medical Office for Urology
Würselen, North Rhine-Westphalia, 52146, Germany
Urban Hospital Karlsruhe
Karlsruhe, Rhineland-Palatinate, 76133, Germany
Hospital "Barmherzigen Brüder "Trier
Trier, Rhineland-Palatinate, 54292, Germany
Center for Urology Boxberg
Neunkirchen, Saarland, 66538, Germany
University Hospital Leipzig
Leipzig, Saxony, 04103, Germany
City Hospital Dessau
Dessau, Saxony-Anhalt, 06847, Germany
Universitiy Hospital Halle
Halle, Saxony-Anhalt, 06120, Germany
University Hospital Halle
Halle, Saxony-Anhalt, 06120, Germany
Urologie Altstadtquartier Magdeburg
Magdeburg, Saxony-Anhalt, 39104, Germany
University Hospital Magdeburg
Magdeburg, Saxony-Anhalt, 39120, Germany
Univerity Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23562, Germany
University Hospital Jena
Jena, Thuringia, 07747, Germany
Biospecimen
Exploratory molecular analyses of leucocyte DNA and RNA, circulating cell-free tumor DNA and RNA (plasma) as well as protein-biomakers (serum) in correlation with clinical outcomes
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marc-Oliver Grimm, Professor
University Hospital Jena
- STUDY DIRECTOR
Boris Hadaschik, Professor
University Hospital, Essen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2025
First Posted
February 19, 2025
Study Start
January 29, 2024
Primary Completion (Estimated)
March 31, 2031
Study Completion (Estimated)
December 31, 2032
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
A Steering Committee is established for the study. SC will decide about requests for specific analyses. In case of positive opinion analyses will be done in-house and results provided to researchers.