PROCARE - PROstate Cancer Real World Evidence Registry

Recruiting

• 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

• Registration Number: NCT06835218
• Lead Sponsor: UroTrials Company (GmbH)

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 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.

Study Timeline

• Study Start: 2024-01-29
• Status Verified: 2025-02
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-13
• Study First Posted: 2025-02-19
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-03
• Primary Completion: 2031-03-31
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Therapy Frequencies and Patterns of Therapy	Through study completion, an average of 7 years	Description of therapy frequencies and patterns in routine clinical practice for the included patient cohorts

Secondary Outcome Measures

Name	Time	Method
Annual (vs. cumulative) Patterns of Disease Management	Through study completion, an average of 7 years	Description of annual (vs. cumulative) patterns of disease management i.e. choice of treatment applied in German routine practice (including initial disease/ metastatic diagnosis and previous cancer drug and non-drug treatments)
Methodology for Disease Status Assessment	Through study completion, an average of 7 years	Methodology used for disease status assessment (e.g. PSA-measurements, imaging)
Frequency for Disease Status Assessment	Through study completion, an average of 7 years	Frequency for disease status assessment (e.g. PSA-measurements, imaging)
Drug Effectiveness Depending on Prior Treatment	Through study completion, an average of 7 years	Assessment of drug effectiveness depending on prior use of an ARPI, docetaxel and other drugs in the BCR, nmCRPC and mHSPC setting as well as prior treatments for mCRPC
Parameters Affecting Prognosis	Through study completion, an average of 7 years	Identification of parameters affecting patients prognosis
Incidence of Adverse Events, serious Adverse Events	Through study completion, an average of 7 years	Incidence of AEs and sAEs including long term safety and tolerability
Treatment Adherence	Through study completion, an average of 7 years	Assessment of Treatment Adherence of patients undergoing different treatment regimes within the distinct cohorts
Assessment of Patient Reported Outcomes for cohort 1	Through study completion, an average of 7 years	Including Patients Quality of Life affected by Treatment using EORTC QLQ-C30 (cohort 1)
Assessment of Patient Reported Outcomes for cohort 2-4 (EQ-5D-5L)	Through study completion, an average of 7 years	Including Patients Quality of Life affected by Treatment using EQ-5D-5L
Assessment of Patient Reported Outcomes for cohort 2-4 (FACT-P)	Through study completion, an average of 7 years	Including Quality of Life by Treatment using FACT-P
Assessment of Patient Paths I	Through study completion, an average of 7 years	Place of Initial and Metastatic Diagnosis, Involved Treatment Facilities, Tumor Board Decisions
Assessment of Patient Paths II	Through study completion, an average of 7 years	Type of Initial and Metastatic Diagnosis, Involved Treatment Facilities, Tumor Board Decisions
Applied Imaging Assessments II	Through study completion, an average of 7 years	PET/CT
Applied Imaging Assessments III	Through study completion, an average of 7 years	Bone scan
Applied Imaging Assessments IV	Through study completion, an average of 7 years	PSMA-SPECT/CT
Applied Imaging Assessments V	Through study completion, an average of 7 years	MRI
Applied Imaging Assessments VI	Through study completion, an average of 7 years	CT
Applied Imaging Assessments VII	Through study completion, an average of 7 years	PSMA PET/CT
Description of Patient and Tumor Characteristics	Through study completion, an average of 7 years	Including Molecular Alterations, if Assessed) in Routine Care of mHSPC and mCRPC Patients

Trial Locations

Locations (27)

University Hospital Tübingen; 🇩🇪 Tübingen, Baden-Württemberg, Germany

University Hospital Ulm; 🇩🇪 Ulm, Baden-Württemberg, Germany

University Hospital Augsburg; 🇩🇪 Augsburg, Bavaria, Germany

Hospital Bayreuth GmbH; 🇩🇪 Bayreuth, Bavaria, Germany

Hospital Nürnberg North; 🇩🇪 Nürnberg, Bavaria, Germany

University Hospital Würzburg; 🇩🇪 Würzburg, Bavaria, Germany

"Vivantes Prostatazentrum" Hospital "am Urban"; 🇩🇪 Berlin, Brandenburg, Germany

Universitiy Hospital Gießen und Marburg GmbH, Site: Gießen; 🇩🇪 Gießen, Hesse, Germany

Universital Hospital Gießen & Marburg GmbH, Site: Marburg; 🇩🇪 Marburg, Hesse, Germany

Hospital Wetzlar; 🇩🇪 Wetzlar, Hesse, Germany

Medical Office for Urology; 🇩🇪 Würselen, North Rhine-Westphalia, Germany

Praxisgemeinschaft f. Onkologie & Urologie; 🇩🇪 Wilhelmshaven, Lower Saxony, Germany

Marien Hospital Bergisch Gladbach,; 🇩🇪 Bergisch Gladbach, North Rhine-Westphalia, Germany

University Hospital Bonn; 🇩🇪 Bonn, North Rhine-Westphalia, Germany

Medical Office for Urology "Urologicum"; 🇩🇪 Duisburg, North Rhine-Westphalia, Germany

University Hospital Essen; 🇩🇪 Essen, North Rhine-Westphalia, Germany

Marien Hospital Herne, University Hospital der Ruhr-Universität Bochum; 🇩🇪 Herne, North Rhine-Westphalia, Germany

"Brüder" Hospital St. Joseph Paderborn; 🇩🇪 Paderborn, North Rhine-Westphalia, Germany

University Hospital Wuppertal; 🇩🇪 Wuppertal, North Rhine-Westphalia, Germany

Urban Hospital Karlsruhe; 🇩🇪 Karlsruhe, Rhineland Palatinate, Germany

Hospital "Barmherzigen Brüder "Trier; 🇩🇪 Trier, Rhineland-Palatinate, Germany

Center for Urology Boxberg; 🇩🇪 Neunkirchen, Saarland, Germany

University Hospital Magdeburg; 🇩🇪 Magdeburg, Saxony-Anhalt, Germany

University Hospital Leipzig; 🇩🇪 Leipzig, Saxony, Germany

Univerity Hospital Schleswig-Holstein; 🇩🇪 Lübeck, Schleswig-Holstein, Germany

University Hospital Jena; 🇩🇪 Jena, Thuringia, Germany

University Hospital Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany