C61
Conditions
Interventions
Group 1: Primary radiotherapy prostate/ seminal vesicles (proton radiotherapy
2.0 Gy (RBE)/ Fx, total dose 74 Gy)
Group 2: Primary radiotherapy prostate/ seminal vesicles/ lymphatic drainage (photon / proton radiotherapy
2.0 Gy (RBE)/ Fx, total dose 74 Gy)
Group 3: postoperative radiotherapy prostatic fossa / seminal vesicles (proton radiotherapy
2.0 Gy (RBE)/ Fx, total dose 66-72 Gy)
Sponsors
Universitätsklinikum DresdenKlinik und Poliklinik für Strahlentherapie und Radioonkologie
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Histologically confirmed, localized, locally advanced or loko-regional advanced prostate cancer - ECOG <= 2 - Indication for curative radiotherapy - Capacity to consent and written consent of the patient
Exclusion criteria
Exclusion criteria: - No known distant metastases (e.g. lung/bones/lymph nodes, etc.) - Missing capacity to consent or lack of written consent - Missing or limited possibility of reproducible positioning (e.g. by severe restriction of mobility of the patient) - Contraindications to rectum balloon - Previous radiation therapy to the pelvis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| >= Grade II toxicity (CTCAE 4.0) after 2 years; evaluation by one-sided one-sample binomial test with normal approximation | — |
Secondary
| Measure | Time frame |
|---|---|
| PSA relapse-free survival , local tumor control, overall survival, prostate cancer specific survival, clinical progression-free survival, acute toxicity >= grade II after 2 years in each case; evaluation by single-sided one-sample binomial test with normal approximation | — |
Countries
Germany
Contacts
Public ContactAnnett Klöber
Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinisches Studienzentrum
Outcome results
None listed