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Clinical Trials in Germany / NCT06835218
Recruiting Observational

PROCARE - PROstate Cancer Real World Evidence Registry

NCT06835218 · tracked via the Priya Life Science Germany tracker
Sponsor
UroTrials Company (GmbH)
Phase
Observational
Started
2024-01-29
Last updated
2026-03-12

Condition(s) studied

Prostate CancerBiochemical Recurrence of Malignant Neoplasm of ProstateNon-metastatic Castration-resistant Prostate CancerMetastatic Hormone-sensitive Prostate Cancer (mHSPC)Metastatic Castration-resistant Prostate Cancer

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (53)

FacilityCityRegionStatus
Universitätsklinikum Freiburg Freiburg im Breisgau Baden-Wurttemberg Recruiting
National Center for Tumor Dieseases (NCT) Heidelberg Heidelberg Baden-Wurttemberg Recruiting
University Hospital Mannheim Mannheim Baden-Wurttemberg Recruiting
Medical Office for Urology Nürtingen Nürtingen Baden-Wurttemberg Recruiting
Studienpraxis Urologie Nürtingen Baden-Wurttemberg Recruiting
University Hospital Tübingen Tübingen Baden-Wurttemberg Recruiting
University Hospital Ulm Ulm Baden-Wurttemberg Recruiting
University Hospital Augsburg Augsburg Bavaria Recruiting
University Hospital Augsburg Augsburg Bavaria Recruiting
Hospital Bayreuth GmbH Bayreuth Bavaria Recruiting
University Hospital Erlangen Erlangen Bavaria Recruiting
Hospital Kempten Kempten (Allgäu) Bavaria Recruiting
Hospital Nürnberg North Nuremberg Bavaria Recruiting
Caritas-Hospital St. Josef Regensburg Bavaria Recruiting
University Hospital Würzburg Würzburg Bavaria Recruiting
"Vivantes Prostatazentrum" Hospital "am Urban" Berlin Brandenburg Recruiting
University Hospital Hamburg-Eppendorf Hamburg Free and Hanseatic City of Hamburg Recruiting
University Hospital Frankfurt/Main Frankfurt am Main Hesse Recruiting
Universitiy Hospital Gießen und Marburg GmbH, Site: Gießen Giessen Hesse Recruiting
Universital Hospital Gießen & Marburg GmbH, Site: Marburg Marburg Hesse Recruiting
Hospital Wetzlar Wetzlar Hesse Recruiting
Medical Office for Urology Braunschweig Lower Saxony Recruiting
Medical Office for Urology Herzberg am Harz Lower Saxony Recruiting
St. Bernward Hospital Hildesheim Hildesheim Lower Saxony Recruiting
St. Bernward Krankenhaus GmbH Hildesheim Lower Saxony Recruiting
Medical Office for Urology Altstadtquartier Magdeburg Magdeburg Lower Saxony Recruiting
MVZ Onco Medical GmbH Neustadt Neustadt am Rübenberge Lower Saxony Recruiting
Praxisgemeinschaft f. Onkologie & Urologie Wilhelmshaven Lower Saxony Recruiting
University Hospital Rostock Rostock Mecklenburg-Vorpommern Recruiting
University Hospital Aachen Aachen North Rhine-Westphalia Recruiting
Medical Office for Urology Bayenthal North Rhine-Westphalia Recruiting
Marien Hospital Bergisch Gladbach, Bergisch Gladbach North Rhine-Westphalia Recruiting
Johanniter GmbH, Johanniterkrankenhaus Bonn North Rhine-Westphalia Recruiting
Johanniter Hosptal Bonn Bonn North Rhine-Westphalia Recruiting
University Hospital Bonn Bonn North Rhine-Westphalia Recruiting
Medical Office for Urology "Urologicum" Duisburg North Rhine-Westphalia Recruiting
University Hospital Düsseldorf Düsseldorf North Rhine-Westphalia Recruiting
University Hospital Essen Essen North Rhine-Westphalia Recruiting
Marien Hospital Herne, University Hospital der Ruhr-Universität Bochum Herne North Rhine-Westphalia Recruiting
"Brüder" Hospital St. Joseph Paderborn Paderborn North Rhine-Westphalia Recruiting

+ 13 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06835218 on ClinicalTrials.gov ↗ ← All trials in Germany