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

Organizational Data

DRKS-ID:
DRKS00033411
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2024-01-15
Last update in DRKS:
2024-02-19
Registration type:
Prospective

Acronym/abbreviation of the study

PROCARE

URL of the study

No Entry

Brief summary in lay language

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.

Brief summary in scientific language

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.

Health condition or problem studied

ICD10:
C61 - Malignant neoplasm of prostate
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
Cohort 1: biochemical recurrence after local curative intended treatment (e.g. radical prostatectomy, radiotherapy of the prostate or combination thereof) For all cohorts during the routine visits, routine data on the course of the disease and therapy are documented 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.
Arm 2:
Cohort 2: non-metastatic castration-resistant prostate cancer
Arm 3:
Cohort 3: metastatic hormone-sensitive prostate cancer
Arm 4:
Cohort 4: metastatic castration-resistant prostate cancer

Endpoints

Primary outcome:
To describe therapy frequencies and patterns of therapy in routine clinical practice for the included patient cohorts
Secondary outcome:
• To describe 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) and • Methodology used and frequency for disease status assessment (e.g. PSA-measurements, imaging) • To assess 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 • To identify parameters affecting prognosis. • Incidence of adverse events, serious adverse events including long term safety and tolerability • Treatment adherence • To assess patient reported outcomes including quality of life by treatment. • To assess patient paths (place/type of initial and metastatic diagnosis, involved treatment facilities, tumor board decisions) • Applied imaging assessments (PSMA PET/CT, CT, PET/CT, MRI, Bone scan, PSMA-SPECT/CT, etc.) • To describe patient and tumor characteristics (including molecular alterations, if assessed) in routine care of mHSPC and mCRPC patients

Study Design

Purpose:
Other
Retrospective/prospective:
Prospective
Study type:
Non-interventional
Longitudinal/cross-sectional:
Longitudinal study
Study type non-interventional:
Patient Registry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Universitätsklinikum Jena, Klinik und Poliklinik für Urologie Jena

Recruitment period and number of participants

Planned study start date:
2024-01-22
Actual study start date:
2024-01-29
Planned study completion date:
2031-03-31
Actual Study Completion Date:
No Entry
Target Sample Size:
5000
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
Male
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional 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

Addresses

Primary Sponsor

UroTrials GmbH
Kantstraße 26
97074 Würzburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

Universitätsklinikum Jena; Klinik und Poliklinik für Urologie
Prof. Dr. Marc-Oliver Grimm
Am Klinikum 1
07747 Jena
Germany
Telephone:
0049 3641 9329901
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Universitätsklinikum Jena; Klinik und Poliklinik für Urologie
Prof. Dr. Marc-Oliver Grimm
Am Klinikum 1
07747 Jena
Germany
Telephone:
0049 3641 9329901
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universitätsklinikum Jena; Klinik und Poliklinik für Urologie
Prof. Dr. Marc-Oliver Grimm
Am Klinikum 1
07747 Jena
Germany
Telephone:
0049 3641 9329901
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Other principal investigator

Universitätsklinikum Essen, Klinik für Urologie
Prof. Dr. Boris Hadaschik
Hufelandstrasse 55
45147 Essen
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Novartis Radiopharmaceuticals GmbH
Roonstraße 25
90429 Nürnberg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Astra Zeneca GmbH
Friesenweg 26
22763 Hamburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
Bachstr. 18
07740 Jena
Germany
Telephone:
+49-3641-9391191
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uniklinikum-jena.de/ethikkommission/

Vote of leading Ethics Committee

Date of ethics committee application:
2023-12-01
Ethics committee number:
2023-3174-BO
Vote of the Ethics Committee:
Approved
Date of the vote:
2024-01-04

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
U1111-1299-5868
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
A Steering Committee is established for the study. SC will decide about requests for specific analyses. In case of positive opinion analyses will be done in-house and results provided to researchers.

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry