Status:
RECRUITING
PROCARE - PROstate Cancer Real World Evidence Registry
Lead Sponsor:
UroTrials Company (GmbH)
Collaborating Sponsors:
Novartis Pharmaceuticals
AstraZeneca
Conditions:
Prostate Cancer
Biochemical Recurrence of Malignant Neoplasm of Prostate
Eligibility:
MALE
18+ years
Brief 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 plann...
Detailed 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 bioche...
Eligibility Criteria
Inclusion
- 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
- • Patients who are not eligible for observation due to severe comorbidities or unavailability according to the treating physician
Key Trial Info
Start Date :
January 29 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2032
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT06835218
Start Date
January 29 2024
End Date
December 31 2032
Last Update
March 12 2026
Active Locations (53)
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1
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
2
National Center for Tumor Dieseases (NCT) Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
3
University Hospital Mannheim
Mannheim, Baden-Wurttemberg, Germany, 68167
4
Medical Office for Urology Nürtingen
Nürtingen, Baden-Wurttemberg, Germany, 72622