PROCARE - PROstate Cancer Real World Evidence Registry

Last updated: February 28, 2025
Sponsor: UroTrials Company (GmbH)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Neoplasms

Prostate Disorders

Treatment

N/A

Clinical Study ID

NCT06835218
UT-2023-01
U1111-1299-5868
DRKS00033411
  • Ages > 18
  • Male

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 Criteria

Inclusion

Inclusion Criteria:

  • Adult prostate cancer patients (age ≥18 years).

  • Diagnosis at time of study inclusion Cohort 1: biochemical recurrence (BCR) afterlocal curative intended treatment (e.g. radical prostatectomy, radiotherapy of theprostate or combination thereof) Cohort 2: non-metastatic castration-resistantprostate 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 entryor up to 4 weeks thereafter. Regarding Cohort 4 this includes patients with a newdiagnosis of mCRPC (=first line mCRPC) after either treatment for mHSPC ornon-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) orlocal treatment is declined by the patient.

  • Patients, who are able and willing to sign the informed consent form

Exclusion

Exclusion Criteria:

• Patients who are not eligible for observation due to severe comorbidities or unavailability according to the treating physician

Study Design

Total Participants: 5000
Study Start date:
January 29, 2024
Estimated Completion Date:
December 31, 2032

Study Description

This prospective real-world data and long-term follow-up registry study aims at documenting routine treatment and course of disease of patients with metastatic prostate cancer and patients with biochemical recurrence after local treatment. This may include the following patient cohorts:

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.

Connect with a study center

  • University Hospital Tübingen

    Tübingen, Baden-Württemberg 72076
    Germany

    Active - Recruiting

  • University Hospital Ulm

    Ulm, Baden-Württemberg 89081
    Germany

    Active - Recruiting

  • University Hospital Augsburg

    Augsburg, Bavaria 86156
    Germany

    Active - Recruiting

  • Hospital Bayreuth GmbH

    Bayreuth, Bavaria 95445
    Germany

    Active - Recruiting

  • Hospital Nürnberg North

    Nürnberg, Bavaria 90419
    Germany

    Active - Recruiting

  • University Hospital Würzburg

    Würzburg, Bavaria 97080
    Germany

    Active - Recruiting

  • "Vivantes Prostatazentrum" Hospital "am Urban"

    Berlin, Brandenburg 10967
    Germany

    Active - Recruiting

  • Universitiy Hospital Gießen und Marburg GmbH, Site: Gießen

    Gießen, Hesse 35392
    Germany

    Active - Recruiting

  • Universital Hospital Gießen & Marburg GmbH, Site: Marburg

    Marburg, Hesse 35043
    Germany

    Active - Recruiting

  • Hospital Wetzlar

    Wetzlar, Hesse 35578
    Germany

    Active - Recruiting

  • Medical Office for Urology

    Braunschweig, Lower Saxony 38100
    Germany

    Active - Recruiting

  • Medical Office for Urology

    Herzberg, Lower Saxony 37412
    Germany

    Active - Recruiting

  • Praxisgemeinschaft f. Onkologie & Urologie

    Wilhelmshaven, Lower Saxony 26389
    Germany

    Active - Recruiting

  • Medical Office for Urology

    Bayenthal, North Rhine-Westphalia 50968
    Germany

    Active - Recruiting

  • Marien Hospital Bergisch Gladbach,

    Bergisch Gladbach, North Rhine-Westphalia 51465
    Germany

    Active - Recruiting

  • University Hospital Bonn

    Bonn, North Rhine-Westphalia 53127
    Germany

    Active - Recruiting

  • Medical Office for Urology "Urologicum"

    Duisburg, North Rhine-Westphalia 47169
    Germany

    Active - Recruiting

  • University Hospital Essen

    Essen, North Rhine-Westphalia 45147
    Germany

    Active - Recruiting

  • Marien Hospital Herne, University Hospital der Ruhr-Universität Bochum

    Herne, North Rhine-Westphalia 44625
    Germany

    Active - Recruiting

  • "Brüder" Hospital St. Joseph Paderborn

    Paderborn, North Rhine-Westphalia 33098
    Germany

    Active - Recruiting

  • University Hospital Wuppertal

    Wuppertal, North Rhine-Westphalia 42283
    Germany

    Active - Recruiting

  • Medical Office for Urology

    Würselen, North Rhine-Westphalia 52146
    Germany

    Active - Recruiting

  • Urban Hospital Karlsruhe

    Karlsruhe, Rhineland Palatinate 76133
    Germany

    Active - Recruiting

  • Hospital "Barmherzigen Brüder "Trier

    Trier, Rhineland-Palatinate 54292
    Germany

    Active - Recruiting

  • Center for Urology Boxberg

    Neunkirchen, Saarland 66538
    Germany

    Active - Recruiting

  • University Hospital Leipzig

    Leipzig, Saxony 04103
    Germany

    Active - Recruiting

  • University Hospital Magdeburg

    Magdeburg, Saxony-Anhalt 39120
    Germany

    Active - Recruiting

  • Univerity Hospital Schleswig-Holstein

    Lübeck, Schleswig-Holstein 23562
    Germany

    Active - Recruiting

  • University Hospital Jena

    Jena, Thuringia 07747
    Germany

    Active - Recruiting

  • University Hospital Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Active - Recruiting

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