C61
Conditions
Interventions
Group 1: A registry is to be created of patients with locally confined (< cT3 and cN0) prostate cancer or oligometastasis who are to undergo curative-intent radiation therapy using stereotactic radiat
Sponsors
Klinik für Strahlentherapie und Radioonkologie
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Informed consent available for the planned study and, if applicable, biobank - Karnofsky performance score = 60 - confirmed localized (< cT3 and cN0) prostate carcinoma or oligometastasis - curative-intended radiotherapy with suitability for SBRT - IPSS (at time of inclusion in the study) < 13 - PACE-B criteria all fulfilled: -- cT1 or cT2 primary -- Gleason score max. 3+4 -- PSA < 20 ng/mL at the start of therapy
Exclusion criteria
Exclusion criteria: - polymetastasis - previous irradiation in the pelvic area - known HIV or hepatitis infection (for biobank) - incapacity to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Creation of a prospective registry with data from patients (longitudinal recording of e.g. success of therapy, acute and chronic side effects, quality of life, dosimetry, costs, biomarkers ...) who receive stereotactic radiotherapy for localised prostate cancer - Gaining knowledge and deriving new research hypotheses | — |
Secondary
| Measure | Time frame |
|---|---|
| - overall survival, progression-free survival, locoregional recurrence, biochemical failure-free survival, disease-free survival, distant metastasis-free survival - clinician reported outcome - patient reported outcome and symptoms - laboratory chemical changes during the course of therapy (PSA dynamics, PSA bounce effect) - Correlation between side effects and dosimetric endpoints, radiotherapy plans, imaging - Recording of decision regret - Absolute treatment costs (for patients and society) | — |
Countries
Germany
Contacts
Public ContactEleni Gkika
Klinik für Strahlentherapie und Radioonkologie
Outcome results
None listed