AzTrials
AzTrials

Prostate CancerPROCARENCT06835218

PROCARE - PROstate Cancer Real World Evidence Registry

An observational study of Prostate Cancer and Biochemical Recurrence of Malignant Neoplasm of Prostate, run by UroTrials Company (GmbH) at 53 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
How many people
5,000 participants
Where
53 sitesGermany
Study dates
29 Jan 2024to 31 Dec 2032
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

53 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Andrea Rößler, PhD contact

00491736872306

andrea.roessler@urotrials.de

Lisa Marx-Blümel, PhD contact

004915202489234

lisa.marx-bluemel@urotrials.de

53 sites in 1 country

Germany53 sites, 53 recruiting

  • University Hospital Aachen

    Aachen, North Rhine-Westphalia, 52074

    Matthias Saar, Professor

    Recruiting

  • University Hospital Augsburg

    Augsburg, Bavaria, 86156

    Julie Steinestel, MD

    Recruiting

  • University Hospital Augsburg

    Augsburg, Bavaria, 86156

    Julia Steinestel, MD

    Recruiting

  • Medical Office for Urology

    Bayenthal, North Rhine-Westphalia, 50968

    Jörg Klier, MD

    Recruiting

  • Hospital Bayreuth GmbH

    Bayreuth, Bavaria, 95445

    Alexander Kiani, Professor

    Recruiting

  • Marien Hospital Bergisch Gladbach,

    Bergisch Gladbach, North Rhine-Westphalia, 51465

    Stephan Machtens, MD

    Recruiting

  • "Vivantes Prostatazentrum" Hospital "am Urban"

    Berlin, Brandenburg, 10967

    Jonas Busch, Professor

    Recruiting

  • Johanniter GmbH, Johanniterkrankenhaus

    Bonn, North Rhine-Westphalia, 53113

    Carsten Ohlmann, Professor

    Recruiting

  • Johanniter Hosptal Bonn

    Bonn, North Rhine-Westphalia, 53113

    Carsten Ohlmann, Professor

    Recruiting

  • University Hospital Bonn

    Bonn, North Rhine-Westphalia, 53127

    Jörg Ellinger, Professor

    Recruiting

  • Medical Office for Urology

    Braunschweig, Lower Saxony, 38100

    Harald Junius, MD

    Recruiting

  • City Hospital Dessau

    Dessau, Saxony-Anhalt, 06847

    Frank-Stefan Sailer

    Recruiting

  • Medical Office for Urology "Urologicum"

    Duisburg, North Rhine-Westphalia, 47169

    Eva Hellmis, MD

    Recruiting

  • University Hospital Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40225

    Günther Niegisch, Professor

    Recruiting

  • University Hospital Erlangen

    Erlangen, Bavaria, 91054

    Peter J. Goebell, Professor

    Recruiting

  • University Hospital Essen

    Essen, North Rhine-Westphalia, 45147

    Boris Hadaschik, Professor

    Recruiting

  • University Hospital Frankfurt/Main

    Frankfurt am Main, Hesse, 60590

    Chun, Professor

    Recruiting

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

    Christian Gratzke, Professor

    Recruiting

  • Universitiy Hospital Gießen und Marburg GmbH, Site: Gießen

    Giessen, Hesse, 35392

    Florian Wagenlehner, Professor

    Recruiting

  • Universitiy Hospital Halle

    Halle, Saxony-Anhalt, 06120

    Georgios Gakis, Professor

    Recruiting

  • University Hospital Halle

    Halle, Saxony-Anhalt, 06120

    Georgios Gakis, Professor

    Recruiting

  • University Hospital Hamburg-Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20246

    Gunhild von Amsberg, Professor

    Recruiting

  • National Center for Tumor Dieseases (NCT) Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

    Stefanie Zschäbitz, MD

    Recruiting

  • Marien Hospital Herne, University Hospital der Ruhr-Universität Bochum

    Herne, North Rhine-Westphalia, 44625

    Florian Roghmann, MD

    Recruiting

  • Medical Office for Urology

    Herzberg am Harz, Lower Saxony, 37412

    Thorsten Werner, MD

    Recruiting

  • St. Bernward Hospital Hildesheim

    Hildesheim, Lower Saxony, 31134

    Ulrich Kaiser, Professor

    Recruiting

  • St. Bernward Krankenhaus GmbH

    Hildesheim, Lower Saxony, 31134

    Ulrich Kaiser, Professor

    Recruiting

  • University Hospital Jena

    Jena, Thuringia, 07747

    Marc-Oliver Grimm, Professor

    Recruiting

  • Urban Hospital Karlsruhe

    Karlsruhe, Rhineland-Palatinate, 76133

    Dogu Teber, Professor

    Recruiting

  • Hospital Kempten

    Kempten (Allgäu), Bavaria, 87439

    Stephan Tschirdewahn, MD

    Recruiting

  • University Hospital Leipzig

    Leipzig, Saxony, 04103

    Jens Uwe Stolzenburg, MD

    Recruiting

  • Univerity Hospital Schleswig-Holstein

    Lübeck, Schleswig-Holstein, 23562

    Axel Merseburger, Professor

    Recruiting

  • Medical Office for Urology Altstadtquartier Magdeburg

    Magdeburg, Lower Saxony, 39104

    Nils Kröger, MD

    Recruiting

  • Urologie Altstadtquartier Magdeburg

    Magdeburg, Saxony-Anhalt, 39104

    Nils Kröger, MD

    Recruiting

  • University Hospital Magdeburg

    Magdeburg, Saxony-Anhalt, 39120

    Schostak Martin, Professor

    Recruiting

  • University Hospital Mannheim

    Mannheim, Baden-Wurttemberg, 68167

    Karl Kowalewski, Professor

    Recruiting

  • Universital Hospital Gießen & Marburg GmbH, Site: Marburg

    Marburg, Hesse, 35043

    Christer Groeben, MD

    Recruiting

  • Center for Urology Boxberg

    Neunkirchen, Saarland, 66538

    Frank Becker, MD

    Recruiting

  • MVZ Onco Medical GmbH Neustadt

    Neustadt am Rübenberge, Lower Saxony, 31535

    Munir Rababah, MD

    Recruiting

  • Hospital Nürnberg North

    Nuremberg, Bavaria, 90419

    Marinela Augustin, MD

    Recruiting

  • Medical Office for Urology Nürtingen

    Nürtingen, Baden-Wurttemberg, 72622

    Tilman Todenhöfer, Professor

    Recruiting

  • Studienpraxis Urologie

    Nürtingen, Baden-Wurttemberg, 72622

    Tillmann Todenhöfer, Professor MD

    Recruiting

  • "Brüder" Hospital St. Joseph Paderborn

    Paderborn, North Rhine-Westphalia, 33098

    Harald Müller-Huesmann, MD

    Recruiting

  • Caritas-Hospital St. Josef

    Regensburg, Bavaria, 93053

    Marco Schnabel, Professor

    Recruiting

  • University Hospital Rostock

    Rostock, Mecklenburg-Vorpommern, 18057

    Angelika Borkewetz, Professor

    Recruiting

  • Hospital "Barmherzigen Brüder "Trier

    Trier, Rhineland-Palatinate, 54292

    Neisius Andreas

    Recruiting

  • University Hospital Tübingen

    Tübingen, Baden-Wurttemberg, 72076

    Steffen Rausch, Professor

    Recruiting

  • University Hospital Ulm

    Ulm, Baden-Wurttemberg, 89081

    Friedemann Zengerling, MD

    Recruiting

  • Hospital Wetzlar

    Wetzlar, Hesse, 35578

    Victor Galonda, MD

    Recruiting

  • Praxisgemeinschaft f. Onkologie & Urologie

    Wilhelmshaven, Lower Saxony, 26389

    Gerald Rodemer, MD

    Recruiting

  • University Hospital Wuppertal

    Wuppertal, North Rhine-Westphalia, 42283

    Stephan Degener, Professor

    Recruiting

  • Medical Office for Urology

    Würselen, North Rhine-Westphalia, 52146

    Thomas Pulte, MD

    Recruiting

  • University Hospital Würzburg

    Würzburg, Bavaria, 97080

    Hubert Kübler, Professor

    Recruiting

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Keywords
prostate, cancer, metastatic, systemic therapy
Medical subject headings
Prostatic Neoplasms, Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06835218
Study groupRoleWhat they receive
Cohort 1: biochemical recurrence (BCR) after local curative intended treatmentNot described
Cohort 2: non-metastatic castration-resistant prostate cancer (nmCRPC)Not described
Cohort 3: metastatic hormone-sensitive prostate cancer (mHSPC)Not described
Cohort 4: metastatic castration-resistant prostate cancer (mCRCP)Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Therapy Frequencies and Patterns of Therapy

    Description of therapy frequencies and patterns in routine clinical practice for the included patient cohorts

    Measured: Through study completion, an average of 7 years

Secondary outcomes (19)

  1. Annual (vs. cumulative) Patterns of Disease Management

    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)

    Measured: Through study completion, an average of 7 years

  2. Methodology for Disease Status Assessment

    Methodology used for disease status assessment (e.g. PSA-measurements, imaging)

    Measured: Through study completion, an average of 7 years

  3. Frequency for Disease Status Assessment

    Frequency for disease status assessment (e.g. PSA-measurements, imaging)

    Measured: Through study completion, an average of 7 years

  4. Drug Effectiveness Depending on Prior Treatment

    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

    Measured: Through study completion, an average of 7 years

  5. Parameters Affecting Prognosis

    Identification of parameters affecting patients prognosis

    Measured: Through study completion, an average of 7 years

  6. Incidence of Adverse Events, serious Adverse Events

    Incidence of AEs and sAEs including long term safety and tolerability

    Measured: Through study completion, an average of 7 years

  7. Treatment Adherence

    Assessment of Treatment Adherence of patients undergoing different treatment regimes within the distinct cohorts

    Measured: Through study completion, an average of 7 years

  8. Assessment of Patient Reported Outcomes for cohort 1

    Including Patients Quality of Life affected by Treatment using EORTC QLQ-C30 (cohort 1)

    Measured: Through study completion, an average of 7 years

  9. Assessment of Patient Reported Outcomes for cohort 2-4 (EQ-5D-5L)

    Including Patients Quality of Life affected by Treatment using EQ-5D-5L

    Measured: Through study completion, an average of 7 years

  10. Assessment of Patient Reported Outcomes for cohort 2-4 (FACT-P)

    Including Quality of Life by Treatment using FACT-P

    Measured: Through study completion, an average of 7 years

  11. Assessment of Patient Paths I

    Place of Initial and Metastatic Diagnosis, Involved Treatment Facilities, Tumor Board Decisions

    Measured: Through study completion, an average of 7 years

  12. Assessment of Patient Paths II

    Type of Initial and Metastatic Diagnosis, Involved Treatment Facilities, Tumor Board Decisions

    Measured: Through study completion, an average of 7 years

  13. Applied Imaging Assessments II

    PET/CT

    Measured: Through study completion, an average of 7 years

  14. Applied Imaging Assessments III

    Bone scan

    Measured: Through study completion, an average of 7 years

  15. Applied Imaging Assessments IV

    PSMA-SPECT/CT

    Measured: Through study completion, an average of 7 years

  16. Applied Imaging Assessments V

    MRI

    Measured: Through study completion, an average of 7 years

  17. Applied Imaging Assessments VI

    CT

    Measured: Through study completion, an average of 7 years

  18. Applied Imaging Assessments VII

    PSMA PET/CT

    Measured: Through study completion, an average of 7 years

  19. Description of Patient and Tumor Characteristics

    Including Molecular Alterations, if Assessed) in Routine Care of mHSPC and mCRPC Patients

    Measured: Through study completion, an average of 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2025
  2. Study start29 Jan 2024
  3. Primary completion31 Mar 2031 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06835218
Sponsor's protocol ID
UT-2023-01
Other IDs
U1111-1299-5868, DRKS00033411
Acronym
PROCARE
Status last verified
Mar 2026
First submitted
6 Feb 2025
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer and Biochemical Recurrence of Malignant Neoplasm of Prostate, run by UroTrials Company (GmbH) at 53 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrea Rößler, PhD (00491736872306, andrea.roessler@urotrials.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Therapy Frequencies and Patterns of Therapy (time frame: Through study completion, an average of 7 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06835218.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in