PROCARE - PROstate Cancer Real World Evidence Registry

Official title

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

Overview

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.

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 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.

Primary outcome measures

• Therapy Frequencies and Patterns of Therapy [Time frame: Through study completion, an average of 7 years]

Secondary outcome measures (12)

• Annual (vs. cumulative) Patterns of Disease Management [Time frame: Through study completion, an average of 7 years]
• Methodology for Disease Status Assessment [Time frame: Through study completion, an average of 7 years]
• Frequency for Disease Status Assessment [Time frame: Through study completion, an average of 7 years]
• Drug Effectiveness Depending on Prior Treatment [Time frame: Through study completion, an average of 7 years]
• Parameters Affecting Prognosis [Time frame: Through study completion, an average of 7 years]
• Incidence of Adverse Events, serious Adverse Events [Time frame: Through study completion, an average of 7 years]
• Treatment Adherence [Time frame: Through study completion, an average of 7 years]
• Assessment of Patient Reported Outcomes for cohort 1 [Time frame: Through study completion, an average of 7 years]
• Assessment of Patient Reported Outcomes for cohort 2-4 (EQ-5D-5L) [Time frame: Through study completion, an average of 7 years]
• Assessment of Patient Reported Outcomes for cohort 2-4 (FACT-P) [Time frame: Through study completion, an average of 7 years]
• Assessment of Patient Paths I [Time frame: Through study completion, an average of 7 years]
• Assessment of Patient Paths II [Time frame: Through study completion, an average of 7 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 53 centers

• Universitätsklinikum Freiburg — Freiburg im Breisgau
• National Center for Tumor Dieseases (NCT) Heidelberg — Heidelberg
• University Hospital Mannheim — Mannheim
• Medical Office for Urology Nürtingen — Nürtingen
• Studienpraxis Urologie — Nürtingen
• University Hospital Tübingen — Tübingen
• University Hospital Ulm — Ulm
• University Hospital Augsburg — Augsburg
• … and 45 more centers

Identifiers

NCT: NCT06835218 · UT-2023-01 · U1111-1299-5868 · DRKS00033411

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗