PROCARE - PROstate Cancer Real World Evidence Registry
Recruiting · NCT06835218 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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
Where it is running
53 locations listed.
- Universitätsklinikum Freiburg - Freiburg im Breisgau, Baden-Wurttemberg, Germany
- National Center for Tumor Dieseases (NCT) Heidelberg - Heidelberg, Baden-Wurttemberg, Germany
- University Hospital Mannheim - Mannheim, Baden-Wurttemberg, Germany
- Medical Office for Urology Nürtingen - Nürtingen, Baden-Wurttemberg, Germany
- Studienpraxis Urologie - Nürtingen, Baden-Wurttemberg, Germany
- University Hospital Tübingen - Tübingen, Baden-Wurttemberg, Germany
- University Hospital Ulm - Ulm, Baden-Wurttemberg, Germany
- University Hospital Augsburg - Augsburg, Bavaria, Germany
- University Hospital Augsburg - Augsburg, Bavaria, Germany
- Hospital Bayreuth GmbH - Bayreuth, Bavaria, Germany
- University Hospital Erlangen - Erlangen, Bavaria, Germany
- Hospital Kempten - Kempten (Allgäu), Bavaria, Germany
- Hospital Nürnberg North - Nuremberg, Bavaria, Germany
- Caritas-Hospital St. Josef - Regensburg, Bavaria, Germany
- University Hospital Würzburg - Würzburg, Bavaria, Germany
- "Vivantes Prostatazentrum" Hospital "am Urban" - Berlin, Brandenburg, Germany
- University Hospital Hamburg-Eppendorf - Hamburg, Free and Hanseatic City of Hamburg, Germany
- University Hospital Frankfurt/Main - Frankfurt am Main, Hesse, Germany
- Universitiy Hospital Gießen und Marburg GmbH, Site: Gießen - Giessen, Hesse, Germany
- Universital Hospital Gießen & Marburg GmbH, Site: Marburg - Marburg, Hesse, Germany
- Hospital Wetzlar - Wetzlar, Hesse, Germany
- Medical Office for Urology - Braunschweig, Lower Saxony, Germany
- Medical Office for Urology - Herzberg am Harz, Lower Saxony, Germany
- St. Bernward Hospital Hildesheim - Hildesheim, Lower Saxony, Germany
- St. Bernward Krankenhaus GmbH - Hildesheim, Lower Saxony, Germany
- Medical Office for Urology Altstadtquartier Magdeburg - Magdeburg, Lower Saxony, Germany
- MVZ Onco Medical GmbH Neustadt - Neustadt am Rübenberge, Lower Saxony, Germany
- Praxisgemeinschaft f. Onkologie & Urologie - Wilhelmshaven, Lower Saxony, Germany
- University Hospital Rostock - Rostock, Mecklenburg-Vorpommern, Germany
- University Hospital Aachen - Aachen, North Rhine-Westphalia, Germany
- Medical Office for Urology - Bayenthal, North Rhine-Westphalia, Germany
- Marien Hospital Bergisch Gladbach, - Bergisch Gladbach, North Rhine-Westphalia, Germany
- Johanniter GmbH, Johanniterkrankenhaus - Bonn, North Rhine-Westphalia, Germany
- Johanniter Hosptal Bonn - Bonn, North Rhine-Westphalia, Germany
- University Hospital Bonn - Bonn, North Rhine-Westphalia, Germany
- Medical Office for Urology "Urologicum" - Duisburg, North Rhine-Westphalia, Germany
- University Hospital Düsseldorf - Düsseldorf, North Rhine-Westphalia, Germany
- University Hospital Essen - Essen, North Rhine-Westphalia, Germany
- Marien Hospital Herne, University Hospital der Ruhr-Universität Bochum - Herne, North Rhine-Westphalia, Germany
- "Brüder" Hospital St. Joseph Paderborn - Paderborn, North Rhine-Westphalia, Germany
- University Hospital Wuppertal - Wuppertal, North Rhine-Westphalia, Germany
- Medical Office for Urology - Würselen, North Rhine-Westphalia, Germany
- Urban Hospital Karlsruhe - Karlsruhe, Rhineland-Palatinate, Germany
- Hospital "Barmherzigen Brüder "Trier - Trier, Rhineland-Palatinate, Germany
- Center for Urology Boxberg - Neunkirchen, Saarland, Germany
- University Hospital Leipzig - Leipzig, Saxony, Germany
- City Hospital Dessau - Dessau, Saxony-Anhalt, Germany
- Universitiy Hospital Halle - Halle, Saxony-Anhalt, Germany
- University Hospital Halle - Halle, Saxony-Anhalt, Germany
- Urologie Altstadtquartier Magdeburg - Magdeburg, Saxony-Anhalt, Germany
- University Hospital Magdeburg - Magdeburg, Saxony-Anhalt, Germany
- Univerity Hospital Schleswig-Holstein - Lübeck, Schleswig-Holstein, Germany
- University Hospital Jena - Jena, Thuringia, Germany