Biochemical Recurrence of Malignant Neoplasm of Prostate, Metastatic Castration-resistant Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Non-metastatic Castration-resistant Prostate Cancer, Prostate Cancer
Conditions
Keywords
prostate, cancer, metastatic, systemic therapy
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.
Interventions
None listed
Sponsors
UroTrials Company (GmbH)
Novartis Pharmaceuticals
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Contacts
CONTACTAndrea Rößler, PhD
CONTACTLisa Marx-Blümel, PhD
STUDY_DIRECTORMarc-Oliver Grimm, Professor
University Hospital Jena
STUDY_DIRECTORBoris Hadaschik, Professor
University Hospital, Essen
Outcome results
None listed