Clinical trial NCT06835218: PROCARE - PROstate Cancer Real World Evidence Registry
Official title: PROstate CAncer Real World Evidence Registry: RECURRENT AND METASTATIC PROSTATE CANCER
Study type: OBSERVATIONAL
Overall status: 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
Keywords: prostate, cancer, metastatic, systemic therapy
Lead sponsor: UroTrials Company (GmbH)
Sponsor class: NETWORK
Collaborators: name: Novartis Pharmaceuticals
name: AstraZeneca
First posted: 2025-02-19
Enrollment: 5000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult prostate cancer patients (age ≥18 years) who will receive a new line of systemic therapy at the time of study entry or up to 4 weeks thereafter.

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.

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

Primary outcomes:
measure: Therapy Frequencies and Patterns of Therapy
timeFrame: Through study completion, an average of 7 years
Secondary outcomes:
measure: Annual (vs. cumulative) Patterns of Disease Management
timeFrame: Through study completion, an average of 7 years
measure: Methodology for Disease Status Assessment
timeFrame: Through study completion, an average of 7 years
measure: Frequency for Disease Status Assessment
timeFrame: Through study completion, an average of 7 years
measure: Drug Effectiveness Depending on Prior Treatment
timeFrame: Through study completion, an average of 7 years
measure: Parameters Affecting Prognosis
timeFrame: Through study completion, an average of 7 years
measure: Incidence of Adverse Events, serious Adverse Events
timeFrame: Through study completion, an average of 7 years
measure: Treatment Adherence
timeFrame: Through study completion, an average of 7 years
measure: Assessment of Patient Reported Outcomes for cohort 1
timeFrame: Through study completion, an average of 7 years
measure: Assessment of Patient Reported Outcomes for cohort 2-4 (EQ-5D-5L)
timeFrame: Through study completion, an average of 7 years
measure: Assessment of Patient Reported Outcomes for cohort 2-4 (FACT-P)
timeFrame: Through study completion, an average of 7 years
measure: Assessment of Patient Paths I
timeFrame: Through study completion, an average of 7 years
measure: Assessment of Patient Paths II
timeFrame: Through study completion, an average of 7 years
measure: Applied Imaging Assessments II
timeFrame: Through study completion, an average of 7 years
measure: Applied Imaging Assessments III
timeFrame: Through study completion, an average of 7 years
measure: Applied Imaging Assessments IV
timeFrame: Through study completion, an average of 7 years
measure: Applied Imaging Assessments V
timeFrame: Through study completion, an average of 7 years
measure: Applied Imaging Assessments VI
timeFrame: Through study completion, an average of 7 years
measure: Applied Imaging Assessments VII
timeFrame: Through study completion, an average of 7 years
measure: Description of Patient and Tumor Characteristics
timeFrame: Through study completion, an average of 7 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: National Center for Tumor Dieseases (NCT) Heidelberg
state: Baden-Württemberg
city: Nürtingen
country: Germany
facility: Medical Office for Urology Nürtingen
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: University Hospital Tübingen
state: Baden-Württemberg
city: Ulm
country: Germany
facility: University Hospital Ulm
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: University Hospital Augsburg
state: Bavaria
city: Bayreuth
country: Germany
facility: Hospital Bayreuth GmbH
state: Bavaria
city: Nürnberg
country: Germany
facility: Hospital Nürnberg North
state: Bavaria
city: Würzburg
country: Germany
facility: University Hospital Würzburg
state: Bavaria
city: Berlin
country: Germany
facility: "Vivantes Prostatazentrum" Hospital "am Urban"
state: Brandenburg
city: Gießen
country: Germany
facility: Universitiy Hospital Gießen und Marburg GmbH, Site: Gießen
state: Hesse
city: Marburg
country: Germany
facility: Universital Hospital Gießen & Marburg GmbH, Site: Marburg
state: Hesse
city: Wetzlar
country: Germany
facility: Hospital Wetzlar
state: Hesse
city: Braunschweig
country: Germany
facility: Medical Office for Urology
state: Lower Saxony
city: Herzberg
country: Germany
facility: Medical Office for Urology
state: Lower Saxony
city: Hildesheim
country: Germany
facility: St. Bernward Hospital Hildesheim
state: Lower Saxony
city: Magdeburg
country: Germany
facility: Medical Office for Urology Altstadtquartier Magdeburg
state: Lower Saxony
city: Wilhelmshaven
country: Germany
facility: Praxisgemeinschaft f. Onkologie & Urologie
state: Lower Saxony
city: Rostock
country: Germany
facility: University Hospital Rostock
state: Mecklenburg-Western Pomerania
city: Bayenthal
country: Germany
facility: Medical Office for Urology
state: North Rhine-Westphalia
city: Bergisch Gladbach
country: Germany
facility: Marien Hospital Bergisch Gladbach,
state: North Rhine-Westphalia
city: Bonn
country: Germany
facility: Johanniter Hosptal Bonn
state: North Rhine-Westphalia
city: Bonn
country: Germany
facility: University Hospital Bonn
state: North Rhine-Westphalia
city: Duisburg
country: Germany
facility: Medical Office for Urology "Urologicum"
state: North Rhine-Westphalia
city: Essen
country: Germany
facility: University Hospital Essen
state: North Rhine-Westphalia
city: Herne
country: Germany
facility: Marien Hospital Herne, University Hospital der Ruhr-Universität Bochum
state: North Rhine-Westphalia
city: Paderborn
country: Germany
facility: "Brüder" Hospital St. Joseph Paderborn
state: North Rhine-Westphalia
city: Wuppertal
country: Germany
facility: University Hospital Wuppertal
state: North Rhine-Westphalia
city: Würselen
country: Germany
facility: Medical Office for Urology
state: North Rhine-Westphalia
city: Karlsruhe
country: Germany
facility: Urban Hospital Karlsruhe
state: Rhineland Palatinate
city: Trier
country: Germany
facility: Hospital "Barmherzigen Brüder "Trier
state: Rhineland-Palatinate
city: Neunkirchen
country: Germany
facility: Center for Urology Boxberg
state: Saarland
city: Halle
country: Germany
facility: Universitiy Hospital Halle
state: Saxony-Anhalt
city: Magdeburg
country: Germany
facility: University Hospital Magdeburg
state: Saxony-Anhalt
city: Leipzig
country: Germany
facility: University Hospital Leipzig
state: Saxony
city: Lübeck
country: Germany
facility: Univerity Hospital Schleswig-Holstein
state: Schleswig-Holstein
city: Jena
country: Germany
facility: University Hospital Jena
state: Thuringia
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf
Study officials:
affiliation: University Hospital Jena
name: Marc-Oliver Grimm, Professor
role: STUDY_DIRECTOR
affiliation: University Hospital, Essen
name: Boris Hadaschik, Professor
role: STUDY_DIRECTOR
References: