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PROCARE - PROstate Cancer Real World Evidence Registry
PROCARE - PROstate Cancer Real World Evidence Registry

NCT06835218

RecruitingN/A

Sponsor: UroTrials Company (GmbH)

Conditions: Prostate Cancer, Biochemical Recurrence of Malignant Neoplasm of Prostate, Non-metastatic Castration-resistant Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Metastatic Castration-resistant Prostate Cancer

Countries: Germany

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 overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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
Locations (53)
  • Freiburg im Breisgau, Baden-Wurttemberg, Germany
  • Heidelberg, Baden-Wurttemberg, Germany
  • Mannheim, Baden-Wurttemberg, Germany
  • Nürtingen, Baden-Wurttemberg, Germany
  • Nürtingen, Baden-Wurttemberg, Germany
  • Tübingen, Baden-Wurttemberg, Germany
  • Ulm, Baden-Wurttemberg, Germany
  • Augsburg, Bavaria, Germany
  • Augsburg, Bavaria, Germany
  • Bayreuth, Bavaria, Germany
  • Erlangen, Bavaria, Germany
  • Kempten (Allgäu), Bavaria, Germany
  • Nuremberg, Bavaria, Germany
  • Regensburg, Bavaria, Germany
  • Würzburg, Bavaria, Germany
  • Berlin, Brandenburg, Germany
  • Hamburg, Free and Hanseatic City of Hamburg, Germany
  • Frankfurt am Main, Hesse, Germany
  • Giessen, Hesse, Germany
  • Marburg, Hesse, Germany
  • Wetzlar, Hesse, Germany
  • Braunschweig, Lower Saxony, Germany
  • Herzberg am Harz, Lower Saxony, Germany
  • Hildesheim, Lower Saxony, Germany
  • Hildesheim, Lower Saxony, Germany
  • Magdeburg, Lower Saxony, Germany
  • Neustadt am Rübenberge, Lower Saxony, Germany
  • Wilhelmshaven, Lower Saxony, Germany
  • Rostock, Mecklenburg-Vorpommern, Germany
  • Aachen, North Rhine-Westphalia, Germany
  • + 23 more on CT.gov