PROstate CAncer Real World Evidence Registry: RECURRENT AND METASTATIC PROSTATE CANCER

Status: Recruiting
Location: See all (46) locations...
Study Type: Observational
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
University Hospital Augsburg
RECRUITING
Augsburg
Medical Office for Urology
RECRUITING
Bayenthal
Hospital Bayreuth GmbH
RECRUITING
Bayreuth
Marien Hospital Bergisch Gladbach,
RECRUITING
Bergisch Gladbach
Vivantes Prostatazentrum Hospital am Urban
RECRUITING
Berlin
Johanniter GmbH, Johanniterkrankenhaus
RECRUITING
Bonn
Johanniter Hosptal Bonn
RECRUITING
Bonn
University Hospital Bonn
RECRUITING
Bonn
Medical Office for Urology
RECRUITING
Braunschweig
Medical Office for Urology Urologicum
RECRUITING
Duisburg
University Hospital Düsseldorf
RECRUITING
Düsseldorf
University Hospital Essen
RECRUITING
Essen
University Hospital Frankfurt/Main
RECRUITING
Frankfurt Am Main
Universitiy Hospital Gießen und Marburg GmbH, Site: Gießen
RECRUITING
Giessen
Universitiy Hospital Halle
RECRUITING
Halle
University Hospital Halle
RECRUITING
Halle
University Hospital Hamburg-Eppendorf
RECRUITING
Hamburg
National Center for Tumor Dieseases (NCT) Heidelberg
RECRUITING
Heidelberg
Marien Hospital Herne, University Hospital der Ruhr-Universität Bochum
RECRUITING
Herne
Medical Office for Urology
RECRUITING
Herzberg Am Harz
St. Bernward Hospital Hildesheim
RECRUITING
Hildesheim
St. Bernward Krankenhaus GmbH
RECRUITING
Hildesheim
University Hospital Jena
RECRUITING
Jena
Urban Hospital Karlsruhe
RECRUITING
Karlsruhe
University Hospital Leipzig
RECRUITING
Leipzig
Univerity Hospital Schleswig-Holstein
RECRUITING
Lübeck
Medical Office for Urology Altstadtquartier Magdeburg
RECRUITING
Magdeburg
University Hospital Magdeburg
RECRUITING
Magdeburg
Urologie Altstadtquartier Magdeburg
RECRUITING
Magdeburg
University Hospital Mannheim
RECRUITING
Mannheim
Universital Hospital Gießen & Marburg GmbH, Site: Marburg
RECRUITING
Marburg
Center for Urology Boxberg
RECRUITING
Neunkirchen
MVZ Onco Medical GmbH Neustadt
RECRUITING
Neustadt Am Rübenberge
Hospital Nürnberg North
RECRUITING
Nuremberg
Medical Office for Urology Nürtingen
RECRUITING
Nürtingen
Studienpraxis Urologie
RECRUITING
Nürtingen
Brüder Hospital St. Joseph Paderborn
RECRUITING
Paderborn
University Hospital Rostock
RECRUITING
Rostock
Hospital Barmherzigen Brüder Trier
RECRUITING
Trier
University Hospital Tübingen
RECRUITING
Tübingen
University Hospital Ulm
RECRUITING
Ulm
Hospital Wetzlar
RECRUITING
Wetzlar
Praxisgemeinschaft f. Onkologie & Urologie
RECRUITING
Wilhelmshaven
University Hospital Wuppertal
RECRUITING
Wuppertal
Medical Office for Urology
RECRUITING
Würselen
University Hospital Würzburg
RECRUITING
Würzburg
Contact Information
Primary
Andrea Rößler, PhD
andrea.roessler@urotrials.de
00491736872306
Backup
Lisa Marx-Blümel, PhD
lisa.marx-bluemel@urotrials.de
004915202489234
Time Frame
Start Date: 2024-01-29
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 5000
Treatments
Cohort 1: biochemical recurrence (BCR) after local curative intended treatment
Cohort 2: non-metastatic castration-resistant prostate cancer (nmCRPC)
Cohort 3: metastatic hormone-sensitive prostate cancer (mHSPC)
Cohort 4: metastatic castration-resistant prostate cancer (mCRCP)
Related Therapeutic Areas
Sponsors
Leads: UroTrials Company (GmbH)
Collaborators: Novartis Pharmaceuticals, AstraZeneca

This content was sourced from clinicaltrials.gov