PROCARE - PROstate Cancer Real World Evidence Registry (PROCARE)

March 10, 2026 updated by: UroTrials Company (GmbH)

PROstate CAncer Real World Evidence Registry: RECURRENT AND METASTATIC PROSTATE CANCER

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This prospective real-world data and long-term follow-up registry study aims at documenting routine treatment and course of disease of patients with metastatic prostate cancer and patients with biochemical recurrence after local treatment. This may include the following patient cohorts:

Cohort 1: biochemical recurrence after local curative intended treatment (e.g. radical prostatectomy, radiotherapy of the prostate or combination thereof) Cohort 2: non-metastatic castration-resistant prostate cancer Cohort 3: metastatic hormone-sensitive prostate cancer Cohort 4: metastatic castration-resistant prostate cancer These cohorts will be recruited independently at various time frames. No specific study treatment is defined. All treatments are prescribed and performed according to each center's medical practice. Any treatment choice or change in regimen is performed at the discretion of each treating physician. During the routine visits, routine data on the course of the disease and therapy are documented for all cohorts at certain time points (after inclusion, then every 3 or 6 months and when changing therapy), standardized quality of life questionnaires (FACT-P and EQ-5D-5L) and biomaterial is collected.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • Recruiting
        • Universitätsklinikum Freiburg
        • Contact:
          • Christian Gratzke, Professor
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Recruiting
        • National Center for Tumor Dieseases (NCT) Heidelberg
        • Contact:
          • Stefanie Zschäbitz, MD
      • Mannheim, Baden-Wurttemberg, Germany, 68167
        • Recruiting
        • University Hospital Mannheim
        • Contact:
          • Karl Kowalewski, Professor
      • Nürtingen, Baden-Wurttemberg, Germany, 72622
        • Recruiting
        • Studienpraxis Urologie
        • Contact:
          • Tillmann Todenhöfer, Professor MD
      • Nürtingen, Baden-Wurttemberg, Germany, 72622
        • Recruiting
        • Medical Office for Urology Nürtingen
        • Contact:
          • Tilman Todenhöfer, Professor
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Recruiting
        • University Hospital Tübingen
        • Contact:
          • Steffen Rausch, Professor
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Recruiting
        • University Hospital Ulm
        • Contact:
          • Friedemann Zengerling, MD
    • Bavaria
      • Augsburg, Bavaria, Germany, 86156
        • Recruiting
        • University Hospital Augsburg
        • Contact:
          • Julia Steinestel, MD
      • Bayreuth, Bavaria, Germany, 95445
        • Recruiting
        • Hospital Bayreuth GmbH
        • Contact:
          • Alexander Kiani, Professor
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • University Hospital Erlangen
        • Contact:
          • Peter J. Goebell, Professor
      • Kempten (Allgäu), Bavaria, Germany, 87439
        • Recruiting
        • Hospital Kempten
        • Contact:
          • Stephan Tschirdewahn, MD
      • Nuremberg, Bavaria, Germany, 90419
        • Recruiting
        • Hospital Nürnberg North
        • Contact:
          • Marinela Augustin, MD
      • Regensburg, Bavaria, Germany, 93053
        • Recruiting
        • Caritas-Hospital St. Josef
        • Contact:
          • Marco Schnabel, Professor
      • Würzburg, Bavaria, Germany, 97080
        • Recruiting
        • University Hospital Wurzburg
        • Contact:
          • Hubert Kübler, Professor
    • Brandenburg
      • Berlin, Brandenburg, Germany, 10967
        • Recruiting
        • "Vivantes Prostatazentrum" Hospital "am Urban"
        • Contact:
          • Jonas Busch, Professor
    • Hamburg
      • Hamburg, Hamburg, Germany, 20246
        • Recruiting
        • University Hospital Hamburg-Eppendorf
        • Contact:
          • Gunhild von Amsberg, Professor
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Recruiting
        • University Hospital Frankfurt/Main
        • Contact:
          • Chun, Professor
      • Giessen, Hesse, Germany, 35392
        • Recruiting
        • Universitiy Hospital Gießen und Marburg GmbH, Site: Gießen
        • Contact:
          • Florian Wagenlehner, Professor
      • Marburg, Hesse, Germany, 35043
        • Recruiting
        • Universital Hospital Gießen & Marburg GmbH, Site: Marburg
        • Contact:
          • Christer Groeben, MD
      • Wetzlar, Hesse, Germany, 35578
        • Recruiting
        • Hospital Wetzlar
        • Contact:
          • Victor Galonda, MD
    • Lower Saxony
      • Braunschweig, Lower Saxony, Germany, 38100
        • Recruiting
        • Medical Office for Urology
        • Contact:
          • Harald Junius, MD
      • Herzberg am Harz, Lower Saxony, Germany, 37412
        • Recruiting
        • Medical Office for Urology
        • Contact:
          • Thorsten Werner, MD
      • Hildesheim, Lower Saxony, Germany, 31134
        • Recruiting
        • St. Bernward Hospital Hildesheim
        • Contact:
          • Ulrich Kaiser, Professor
      • Hildesheim, Lower Saxony, Germany, 31134
        • Recruiting
        • St. Bernward Krankenhaus GmbH
        • Contact:
          • Ulrich Kaiser, Professor
      • Magdeburg, Lower Saxony, Germany, 39104
        • Recruiting
        • Medical Office for Urology Altstadtquartier Magdeburg
        • Contact:
          • Nils Kröger, MD
      • Neustadt am Rübenberge, Lower Saxony, Germany, 31535
        • Recruiting
        • MVZ Onco Medical GmbH Neustadt
        • Contact:
          • Munir Rababah, MD
      • Wilhelmshaven, Lower Saxony, Germany, 26389
        • Recruiting
        • Praxisgemeinschaft f. Onkologie & Urologie
        • Contact:
          • Gerald Rodemer, MD
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18057
        • Recruiting
        • University Hospital Rostock
        • Contact:
          • Angelika Borkewetz, Professor
    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Germany, 52074
        • Recruiting
        • University Hospital Aachen
        • Contact:
          • Matthias Saar, Professor
      • Bayenthal, North Rhine-Westphalia, Germany, 50968
        • Recruiting
        • Medical Office for Urology
        • Contact:
          • Jörg Klier, MD
      • Bergisch Gladbach, North Rhine-Westphalia, Germany, 51465
        • Recruiting
        • Marien Hospital Bergisch Gladbach,
        • Contact:
          • Stephan Machtens, MD
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Recruiting
        • University Hospital Bonn
        • Contact:
          • Jörg Ellinger, Professor
      • Bonn, North Rhine-Westphalia, Germany, 53113
        • Recruiting
        • Johanniter Hosptal Bonn
        • Contact:
          • Carsten Ohlmann, Professor
      • Bonn, North Rhine-Westphalia, Germany, 53113
        • Recruiting
        • Johanniter GmbH, Johanniterkrankenhaus
        • Contact:
          • Carsten Ohlmann, Professor
      • Duisburg, North Rhine-Westphalia, Germany, 47169
        • Recruiting
        • Medical Office for Urology "Urologicum"
        • Contact:
          • Eva Hellmis, MD
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Recruiting
        • University Hospital Düsseldorf
        • Contact:
          • Günther Niegisch, Professor
      • Essen, North Rhine-Westphalia, Germany, 45147
        • Recruiting
        • University Hospital Essen
        • Contact:
          • Boris Hadaschik, Professor
      • Herne, North Rhine-Westphalia, Germany, 44625
        • Recruiting
        • Marien Hospital Herne, University Hospital der Ruhr-Universität Bochum
        • Contact:
          • Florian Roghmann, MD
      • Paderborn, North Rhine-Westphalia, Germany, 33098
        • Recruiting
        • "Brüder" Hospital St. Joseph Paderborn
        • Contact:
          • Harald Müller-Huesmann, MD
      • Wuppertal, North Rhine-Westphalia, Germany, 42283
        • Recruiting
        • University Hospital Wuppertal
        • Contact:
          • Stephan Degener, Professor
      • Würselen, North Rhine-Westphalia, Germany, 52146
        • Recruiting
        • Medical Office for Urology
        • Contact:
          • Thomas Pulte, MD
    • Rhineland-Palatinate
      • Karlsruhe, Rhineland-Palatinate, Germany, 76133
        • Recruiting
        • Urban Hospital Karlsruhe
        • Contact:
          • Dogu Teber, Professor
      • Trier, Rhineland-Palatinate, Germany, 54292
        • Recruiting
        • Hospital "Barmherzigen Brüder "Trier
        • Contact:
          • Neisius Andreas
    • Saarland
      • Neunkirchen, Saarland, Germany, 66538
        • Recruiting
        • Center for Urology Boxberg
        • Contact:
          • Frank Becker, MD
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • University Hospital Leipzig
        • Contact:
          • Jens Uwe Stolzenburg, MD
    • Saxony-Anhalt
      • Dessau, Saxony-Anhalt, Germany, 06847
        • Recruiting
        • City Hospital Dessau
        • Contact:
          • Frank-Stefan Sailer
      • Halle, Saxony-Anhalt, Germany, 06120
        • Recruiting
        • Universitiy Hospital Halle
        • Contact:
          • Georgios Gakis, Professor
      • Halle, Saxony-Anhalt, Germany, 06120
        • Recruiting
        • University Hospital Halle
        • Contact:
          • Georgios Gakis, Professor
      • Magdeburg, Saxony-Anhalt, Germany, 39120
        • Recruiting
        • University Hospital Magdeburg
        • Contact:
          • Schostak Martin, Professor
      • Magdeburg, Saxony-Anhalt, Germany, 39104
        • Recruiting
        • Urologie Altstadtquartier Magdeburg
        • Contact:
          • Nils Kröger, MD
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23562
        • Recruiting
        • Univerity Hospital Schleswig-Holstein
        • Contact:
          • Axel Merseburger, Professor
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • Recruiting
        • University Hospital Jena
        • Contact:
          • Marc-Oliver Grimm, Professor

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • Adult prostate cancer patients (age ≥18 years).
  • Diagnosis at time of study inclusion Cohort 1: biochemical recurrence (BCR) after local curative intended treatment (e.g. radical prostatectomy, radiotherapy of the prostate or combination thereof) Cohort 2: non-metastatic castration-resistant prostate cancer (nmCRPC) or Cohort 3: metastatic hormone sensitive prostate cancer (mHSPC) or Cohort 4: metastatic castration-resistant prostate cancer (mCRPC) (irrespective of treatment choice, treatment line)
  • 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

Exclusion Criteria:

• Patients who are not eligible for observation due to severe comorbidities or unavailability according to the treating physician

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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapy Frequencies and Patterns of Therapy
Time Frame: Through study completion, an average of 7 years
Description of therapy frequencies and patterns in routine clinical practice for the included patient cohorts
Through study completion, an average of 7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annual (vs. cumulative) Patterns of Disease Management
Time Frame: Through study completion, an average of 7 years
Description of annual (vs. cumulative) patterns of disease management i.e. choice of treatment applied in German routine practice (including initial disease/ metastatic diagnosis and previous cancer drug and non-drug treatments)
Through study completion, an average of 7 years
Methodology for Disease Status Assessment
Time Frame: Through study completion, an average of 7 years
Methodology used for disease status assessment (e.g. PSA-measurements, imaging)
Through study completion, an average of 7 years
Frequency for Disease Status Assessment
Time Frame: Through study completion, an average of 7 years
Frequency for disease status assessment (e.g. PSA-measurements, imaging)
Through study completion, an average of 7 years
Drug Effectiveness Depending on Prior Treatment
Time Frame: Through study completion, an average of 7 years
Assessment of drug effectiveness depending on prior use of an ARPI, docetaxel and other drugs in the BCR, nmCRPC and mHSPC setting as well as prior treatments for mCRPC
Through study completion, an average of 7 years
Parameters Affecting Prognosis
Time Frame: Through study completion, an average of 7 years
Identification of parameters affecting patients prognosis
Through study completion, an average of 7 years
Incidence of Adverse Events, serious Adverse Events
Time Frame: Through study completion, an average of 7 years
Incidence of AEs and sAEs including long term safety and tolerability
Through study completion, an average of 7 years
Assessment of Patient Paths I
Time Frame: Through study completion, an average of 7 years
Place of Initial and Metastatic Diagnosis, Involved Treatment Facilities, Tumor Board Decisions
Through study completion, an average of 7 years
Assessment of Patient Paths II
Time Frame: Through study completion, an average of 7 years
Type of Initial and Metastatic Diagnosis, Involved Treatment Facilities, Tumor Board Decisions
Through study completion, an average of 7 years
Applied Imaging Assessments II
Time Frame: Through study completion, an average of 7 years
PET/CT
Through study completion, an average of 7 years
Applied Imaging Assessments III
Time Frame: Through study completion, an average of 7 years
Bone scan
Through study completion, an average of 7 years
Applied Imaging Assessments IV
Time Frame: Through study completion, an average of 7 years
PSMA-SPECT/CT
Through study completion, an average of 7 years
Applied Imaging Assessments V
Time Frame: Through study completion, an average of 7 years
MRI
Through study completion, an average of 7 years
Applied Imaging Assessments VI
Time Frame: Through study completion, an average of 7 years
CT
Through study completion, an average of 7 years
Applied Imaging Assessments VII
Time Frame: Through study completion, an average of 7 years
PSMA PET/CT
Through study completion, an average of 7 years
Description of Patient and Tumor Characteristics
Time Frame: Through study completion, an average of 7 years
Including Molecular Alterations, if Assessed) in Routine Care of mHSPC and mCRPC Patients
Through study completion, an average of 7 years
Treatment Adherence
Time Frame: Through study completion, an average of 7 years
Assessment of Treatment Adherence of patients undergoing different treatment regimes within the distinct cohorts
Through study completion, an average of 7 years
Assessment of Patient Reported Outcomes for cohort 1
Time Frame: Through study completion, an average of 7 years
Including Patients Quality of Life affected by Treatment using EORTC QLQ-C30 (cohort 1)
Through study completion, an average of 7 years
Assessment of Patient Reported Outcomes for cohort 2-4 (EQ-5D-5L)
Time Frame: Through study completion, an average of 7 years
Including Patients Quality of Life affected by Treatment using EQ-5D-5L
Through study completion, an average of 7 years
Assessment of Patient Reported Outcomes for cohort 2-4 (FACT-P)
Time Frame: Through study completion, an average of 7 years
Including Quality of Life by Treatment using FACT-P
Through study completion, an average of 7 years

Collaborators and Investigators

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

Sponsor

UroTrials Company (GmbH)

Collaborators

AstraZeneca
Novartis Pharmaceuticals

Investigators

  • Study Director: Marc-Oliver Grimm, Professor, University Hospital Jena
  • Study Director: Boris Hadaschik, Professor, University Hospital, Essen

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)

January 29, 2024

Primary Completion (Estimated)

March 31, 2031

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

February 19, 2025

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UT-2023-01
  • U1111-1299-5868 (Registry Identifier: WHO Universal Trial Number)
  • DRKS00033411 (Registry Identifier: German Clinical Trials Register)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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