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.
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 Type
OBSERVATIONAL
Enrollment
5,000
National Center for Tumor Dieseases (NCT) Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
RECRUITINGUniversity Hospital Mannheim
Mannheim, Baden-Wurttemberg, Germany
RECRUITINGMedical Office for Urology Nürtingen
Nürtingen, Baden-Wurttemberg, Germany
RECRUITINGStudienpraxis Urologie
Nürtingen, Baden-Wurttemberg, Germany
Therapy Frequencies and Patterns of Therapy
Description of therapy frequencies and patterns in routine clinical practice for the included patient cohorts
Time frame: Through study completion, an average of 7 years
Annual (vs. cumulative) Patterns of Disease Management
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)
Time frame: Through study completion, an average of 7 years
Methodology for Disease Status Assessment
Methodology used for disease status assessment (e.g. PSA-measurements, imaging)
Time frame: Through study completion, an average of 7 years
Frequency for Disease Status Assessment
Frequency for disease status assessment (e.g. PSA-measurements, imaging)
Time frame: Through study completion, an average of 7 years
Drug Effectiveness Depending on Prior Treatment
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
Time frame: Through study completion, an average of 7 years
Parameters Affecting Prognosis
Identification of parameters affecting patients prognosis
Time frame: Through study completion, an average of 7 years
Incidence of Adverse Events, serious Adverse Events
Incidence of AEs and sAEs including long term safety and tolerability
Time frame: Through study completion, an average of 7 years
Treatment Adherence
Assessment of Treatment Adherence of patients undergoing different treatment regimes within the distinct cohorts
Time frame: Through study completion, an average of 7 years
Assessment of Patient Reported Outcomes for cohort 1
Including Patients Quality of Life affected by Treatment using EORTC QLQ-C30 (cohort 1)
Time frame: Through study completion, an average of 7 years
Assessment of Patient Reported Outcomes for cohort 2-4 (EQ-5D-5L)
Including Patients Quality of Life affected by Treatment using EQ-5D-5L
Time frame: Through study completion, an average of 7 years
Assessment of Patient Reported Outcomes for cohort 2-4 (FACT-P)
Including Quality of Life by Treatment using FACT-P
Time frame: Through study completion, an average of 7 years
Assessment of Patient Paths I
Place of Initial and Metastatic Diagnosis, Involved Treatment Facilities, Tumor Board Decisions
Time frame: Through study completion, an average of 7 years
Assessment of Patient Paths II
Type of Initial and Metastatic Diagnosis, Involved Treatment Facilities, Tumor Board Decisions
Time frame: Through study completion, an average of 7 years
Applied Imaging Assessments II
PET/CT
Time frame: Through study completion, an average of 7 years
Applied Imaging Assessments III
Bone scan
Time frame: Through study completion, an average of 7 years
Applied Imaging Assessments IV
PSMA-SPECT/CT
Time frame: Through study completion, an average of 7 years
Applied Imaging Assessments V
MRI
Time frame: Through study completion, an average of 7 years
Applied Imaging Assessments VI
CT
Time frame: Through study completion, an average of 7 years
Applied Imaging Assessments VII
PSMA PET/CT
Time frame: Through study completion, an average of 7 years
Description of Patient and Tumor Characteristics
Including Molecular Alterations, if Assessed) in Routine Care of mHSPC and mCRPC Patients
Time frame: Through study completion, an average of 7 years
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University Hospital Tübingen
Tübingen, Baden-Wurttemberg, Germany
RECRUITINGUniversity Hospital Ulm
Ulm, Baden-Wurttemberg, Germany
RECRUITINGUniversity Hospital Augsburg
Augsburg, Bavaria, Germany
RECRUITINGUniversity Hospital Augsburg
Augsburg, Bavaria, Germany
RECRUITINGHospital Bayreuth GmbH
Bayreuth, Bavaria, Germany
RECRUITINGUniversity Hospital Erlangen
Erlangen, Bavaria, Germany
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