PSA-recurrence prostate carcinoma is associated with two general problems. 1. Localisation of PSA-recurrence is unconfident. In many cases it's not clear if a local, locoregional oder systemic relapse is available. 2. There is no standard therapy proved by randomised clinical trials. Recommended radiotherapy starting with PSA-value \< 0.5 ng/ml according to german S3 guidelines is based on retrospective data. These difficulties may lead to a therapy potentially not adapted to patients situation of disease.This study aims to randomised examine if an instant radiotherapy of prostate PSA-recurrence (PSA-value between 0.2 - 0.99 ng/ml) or a delayed radiotherapy with additional imaging (PSA value \>= 1 ng/ml) including PET/CT and bone scintigraphy for reliable information about tumor location and expansion is beneficial regarding therapy efficiency, quality of life and social economic aspects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
PET/CT
Instant Radiotherapy according to guidelines
Radiotherapy after achievement of PSA marginal value
Disease-free survival according to PSA-value
Subjects in the control arm have an aftertreatment period of 5 years. Follow-up period of intervention arm ends after 3 to 5 years after radiotherapy. Duration depends on the surveillance period until marginal value is reached. This period is subtracted from maximum follow-up period of 5 years.
Time frame: at the end of follow-up period of 4 years
frequency of PSA-persistence
Time frame: at the end of therapy , an expected average of 6 weeks
frequency of changes in therapeutic strategies by additional diagnostics
Time frame: at the end of therapy , an expected average of 6 weeks
analysis for radiation parameters, restricted to patients of initiating center
Time frame: at the end of therapy , an expected average of 6 weeks
therapy and following costs for patients
Time frame: time frame of 2 weeks before therapy starts; at the end of therapy , an expected average of 6 weeks; during follow-up each 3 months for the first 2 years, then each 6 months for the rest of follow-up period, an expected average of 2 further years
overall survival
Time frame: at the end of therapy , an expected average of 6 weeks
quality of life and side effects
Time frame: time frame of 2 weeks before therapy starts; at the end of therapy , an expected average of 6 weeks; during follow-up each 3 months for the first 2 years, then each 6 months for the rest of follow-up period, an expected average of 2 further years
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