Registry for prostate cancer treatment and outcomes
PROstate CAncer Real World Evidence Registry: RECURRENT AND METASTATIC PROSTATE CANCER
This study is tracking the treatment and progress of men with recurrent and advanced prostate cancer to see how different therapies affect their lives over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | UroTrials Company (GmbH) Research network |
| Drugs / interventions | radiation |
| Locations | 53 sites (Freiburg im Breisgau, Baden-Wurttemberg and 52 other locations) |
| Trial ID | NCT06835218 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to document the treatment course and disease progression in patients with recurrent and metastatic prostate cancer. It includes various cohorts such as those with biochemical recurrence after local treatment, non-metastatic castration-resistant prostate cancer, and metastatic hormone-sensitive and castration-resistant prostate cancer. Patients will be followed over time with routine data collection on their treatment and quality of life, allowing for a comprehensive understanding of real-world outcomes. The study does not specify any particular treatment, as all therapies will be determined by the treating physicians.
Who should consider this trial
Good fit: Ideal candidates include adult patients diagnosed with different stages of prostate cancer, particularly those experiencing biochemical recurrence or metastatic disease.
Not a fit: Patients with early-stage prostate cancer who have not yet undergone treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the effectiveness of various treatments for prostate cancer, ultimately improving patient care.
How similar studies have performed: Other observational studies have successfully documented treatment outcomes in prostate cancer, suggesting that this approach is both valid and valuable.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Freiburg im Breisgau, Baden-Wurttemberg and 52 other locations
- Universitätsklinikum Freiburg — Freiburg im Breisgau, Baden-Wurttemberg, Germany (Recruiting)
- National Center for Tumor Dieseases (NCT) Heidelberg — Heidelberg, Baden-Wurttemberg, Germany (Recruiting)
- University Hospital Mannheim — Mannheim, Baden-Wurttemberg, Germany (Recruiting)
- Medical Office for Urology Nürtingen — Nürtingen, Baden-Wurttemberg, Germany (Recruiting)
- Studienpraxis Urologie — Nürtingen, Baden-Wurttemberg, Germany (Recruiting)
- University Hospital Tübingen — Tübingen, Baden-Wurttemberg, Germany (Recruiting)
- University Hospital Ulm — Ulm, Baden-Wurttemberg, Germany (Recruiting)
- University Hospital Augsburg — Augsburg, Bavaria, Germany (Recruiting)
- University Hospital Augsburg — Augsburg, Bavaria, Germany (Recruiting)
- Hospital Bayreuth GmbH — Bayreuth, Bavaria, Germany (Recruiting)
- University Hospital Erlangen — Erlangen, Bavaria, Germany (Recruiting)
- Hospital Kempten — Kempten (Allgäu), Bavaria, Germany (Recruiting)
- Hospital Nürnberg North — Nuremberg, Bavaria, Germany (Recruiting)
- Caritas-Hospital St. Josef — Regensburg, Bavaria, Germany (Recruiting)
- University Hospital Würzburg — Würzburg, Bavaria, Germany (Recruiting)
- "Vivantes Prostatazentrum" Hospital "am Urban" — Berlin, Brandenburg, Germany (Recruiting)
- University Hospital Hamburg-Eppendorf — Hamburg, Free and Hanseatic City of Hamburg, Germany (Recruiting)
- University Hospital Frankfurt/Main — Frankfurt am Main, Hesse, Germany (Recruiting)
- Universitiy Hospital Gießen und Marburg GmbH, Site: Gießen — Giessen, Hesse, Germany (Recruiting)
- Universital Hospital Gießen & Marburg GmbH, Site: Marburg — Marburg, Hesse, Germany (Recruiting)
- Hospital Wetzlar — Wetzlar, Hesse, Germany (Recruiting)
- Medical Office for Urology — Braunschweig, Lower Saxony, Germany (Recruiting)
- Medical Office for Urology — Herzberg am Harz, Lower Saxony, Germany (Recruiting)
- St. Bernward Hospital Hildesheim — Hildesheim, Lower Saxony, Germany (Recruiting)
- St. Bernward Krankenhaus GmbH — Hildesheim, Lower Saxony, Germany (Recruiting)
- Medical Office for Urology Altstadtquartier Magdeburg — Magdeburg, Lower Saxony, Germany (Recruiting)
- MVZ Onco Medical GmbH Neustadt — Neustadt am Rübenberge, Lower Saxony, Germany (Recruiting)
- Praxisgemeinschaft f. Onkologie & Urologie — Wilhelmshaven, Lower Saxony, Germany (Recruiting)
- University Hospital Rostock — Rostock, Mecklenburg-Vorpommern, Germany (Recruiting)
- University Hospital Aachen — Aachen, North Rhine-Westphalia, Germany (Recruiting)
- Medical Office for Urology — Bayenthal, North Rhine-Westphalia, Germany (Recruiting)
- Marien Hospital Bergisch Gladbach, — Bergisch Gladbach, North Rhine-Westphalia, Germany (Recruiting)
- Johanniter GmbH, Johanniterkrankenhaus — Bonn, North Rhine-Westphalia, Germany (Recruiting)
- Johanniter Hosptal Bonn — Bonn, North Rhine-Westphalia, Germany (Recruiting)
- University Hospital Bonn — Bonn, North Rhine-Westphalia, Germany (Recruiting)
- Medical Office for Urology "Urologicum" — Duisburg, North Rhine-Westphalia, Germany (Recruiting)
- University Hospital Düsseldorf — Düsseldorf, North Rhine-Westphalia, Germany (Recruiting)
- University Hospital Essen — Essen, North Rhine-Westphalia, Germany (Recruiting)
- Marien Hospital Herne, University Hospital der Ruhr-Universität Bochum — Herne, North Rhine-Westphalia, Germany (Recruiting)
- "Brüder" Hospital St. Joseph Paderborn — Paderborn, North Rhine-Westphalia, Germany (Recruiting)
- University Hospital Wuppertal — Wuppertal, North Rhine-Westphalia, Germany (Recruiting)
- Medical Office for Urology — Würselen, North Rhine-Westphalia, Germany (Recruiting)
- Urban Hospital Karlsruhe — Karlsruhe, Rhineland-Palatinate, Germany (Recruiting)
- Hospital "Barmherzigen Brüder "Trier — Trier, Rhineland-Palatinate, Germany (Recruiting)
- Center for Urology Boxberg — Neunkirchen, Saarland, Germany (Recruiting)
- University Hospital Leipzig — Leipzig, Saxony, Germany (Recruiting)
- City Hospital Dessau — Dessau, Saxony-Anhalt, Germany (Recruiting)
- Universitiy Hospital Halle — Halle, Saxony-Anhalt, Germany (Recruiting)
- University Hospital Halle — Halle, Saxony-Anhalt, Germany (Recruiting)
- Urologie Altstadtquartier Magdeburg — Magdeburg, Saxony-Anhalt, Germany (Recruiting)
+3 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Andrea Rößler, PhD
- Email: andrea.roessler@urotrials.de
- Phone: 00491736872306
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.