NCT06835218

PROCARE - PROstate Cancer Real World Evidence Registry

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: UroTrials Company (GmbH) · Network
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

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

Timeline

• Start date: 2024-01-29
• Primary completion: 2031-03-31
• Completion: 2032-12-31
• First posted: 2025-02-19
• Last updated: 2026-03-12

Locations

53 sites across 1 country: Germany