Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2024-01-29
2032-12-31
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1: biochemical recurrence (BCR) after local curative intended treatment
No interventions assigned to this group
Cohort 2: non-metastatic castration-resistant prostate cancer (nmCRPC)
No interventions assigned to this group
Cohort 3: metastatic hormone-sensitive prostate cancer (mHSPC)
No interventions assigned to this group
Cohort 4: metastatic castration-resistant prostate cancer (mCRCP)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
AstraZeneca
INDUSTRY
UroTrials Company (GmbH)
NETWORK
Responsible Party
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Principal Investigators
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Marc-Oliver Grimm, Professor
Role: STUDY_DIRECTOR
University Hospital Jena
Boris Hadaschik, Professor
Role: STUDY_DIRECTOR
University Hospital, Essen
Locations
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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, 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
Countries
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Central Contacts
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Facility Contacts
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Stefanie Zschäbitz, MD
Role: primary
Karl Kowalewski, Professor
Role: primary
Tilman Todenhöfer, Professor
Role: primary
Tillmann Todenhöfer, Professor MD
Role: primary
Steffen Rausch, Professor
Role: primary
Friedemann Zengerling, MD
Role: primary
Julie Steinestel, MD
Role: primary
Julia Steinestel, MD
Role: primary
Alexander Kiani, Professor
Role: primary
Peter J. Goebell, Professor
Role: primary
Stephan Tschirdewahn, MD
Role: primary
Marinela Augustin, MD
Role: primary
Marco Schnabel, Professor
Role: primary
Hubert Kübler, Professor
Role: primary
Jonas Busch, Professor
Role: primary
Gunhild von Amsberg, Professor
Role: primary
Chun, Professor
Role: primary
Florian Wagenlehner, Professor
Role: primary
Christer Groeben, MD
Role: primary
Victor Galonda, MD
Role: primary
Harald Junius, MD
Role: primary
Thorsten Werner, MD
Role: primary
Ulrich Kaiser, Professor
Role: primary
Ulrich Kaiser, Professor
Role: primary
Nils Kröger, MD
Role: primary
Munir Rababah, MD
Role: primary
Gerald Rodemer, MD
Role: primary
Angelika Borkewetz, Professor
Role: primary
Matthias Saar, Professor
Role: primary
Jörg Klier, MD
Role: primary
Stephan Machtens, MD
Role: primary
Carsten Ohlmann, Professor
Role: primary
Carsten Ohlmann, Professor
Role: primary
Jörg Ellinger, Professor
Role: primary
Eva Hellmis, MD
Role: primary
Günther Niegisch, Professor
Role: primary
Boris Hadaschik, Professor
Role: primary
Florian Roghmann, MD
Role: primary
Harald Müller-Huesmann, MD
Role: primary
Stephan Degener, Professor
Role: primary
Thomas Pulte, MD
Role: primary
Dogu Teber, Professor
Role: primary
Neisius Andreas
Role: primary
Frank Becker, MD
Role: primary
Jens Uwe Stolzenburg, MD
Role: primary
Frank-Stefan Sailer
Role: primary
Georgios Gakis, Professor
Role: primary
Georgios Gakis, Professor
Role: primary
Nils Kröger, MD
Role: primary
Schostak Martin, Professor
Role: primary
Axel Merseburger, Professor
Role: primary
Marc-Oliver Grimm, Professor
Role: primary
Other Identifiers
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U1111-1299-5868
Identifier Type: REGISTRY
Identifier Source: secondary_id
DRKS00033411
Identifier Type: REGISTRY
Identifier Source: secondary_id
UT-2023-01
Identifier Type: -
Identifier Source: org_study_id
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