C61
Conditions
Interventions
Group 1: Hypofractionated photon radiation therapy with a total dose of 62 Gy in 20 fractions (3.1 Gy single dose) over approx. 4 weeks.
Group 2: Hypofractionated proton beam therapy with a total dose
Sponsors
Philipps-Universität Marburg
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Histologically confirmed diagnosis of prostate adenocarcinoma - Clinical stage T1-T3 - Gleason score = 8 - Indication for hypofractionated radiotherapy with a total radiation dose of 62 Gy (RBE). - ECOG performance status 0-2 - Age = 18 years - Ability to give informed consent - Willingness to complete questionnaires on quality of life and to attend regular study visits - Availability of a written declaration of consent
Exclusion criteria
Exclusion criteria: - Previous radiation or chemotherapy of the pelvis for prostate tumors. - Concurrent radiation therapy of the pelvis - Previous prostate tumor treatments such as prostatectomy or cryotherapy. - Concurrent cytotoxic chemotherapy - Evidence of lymph node involvement or distant metastases - Presence of a hip prosthesis or other conditions that could interfere with imaging. - Severe urinary symptoms (IPSS > 20) - Concurrent participation in another clinical trial that conflicts with this trial - Incapable of giving consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of acute GI toxicities grade = 2 (start of radiotherapy to 12 weeks after end of radiotherapy) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Acute GU toxicity: incidence of acute GU toxicities grade = 2 (from start of radiotherapy to 12 weeks after end of radiotherapy -Long-term survival: disease-specific survival (DSS), overall survival (OS), and biochemical progression-free survival (bPFS) -Quality of life: disease-specific quality of life according to EORTC-QLQ-C30 and QLQ-PR25 -Long-term toxicities: frequency of late GI and GU toxicities grade = 2 toxicities (12 weeks after end of RT until end of follow-up) -Radiation dose and function: Development of prediction models to investigate the relationships between selected parameters of individual radiation dose distributions and the intestinal, urinary and erectile function reported by patients -Identification and evaluation of biomarkers: Identification and evaluation of biomarkers for prostate tumor behavior and response to radiation therapy -Representativeness/generalizability: Investigation of the use of a participant registry to evaluate the representativeness and generalizability of the results of the randomized study to a broader spectrum of eligible patients and provision of pilot information for a subsequent larger multicenter registry -Patient perspective on organ preservation: Evaluation of patients' reasons for choosing non-surgical treatment | — |
Countries
Germany
Outcome results
None listed