The purpose of this randomized trial is to investigate the efficacy and toxicity of percutaneous high-dose radiotherapy in patients with oligometastases of hormone refractory prostate cancer. The effectiveness will be tested in comparison to an observation group, in which no further therapy is initially given. Treatment can be stereotactically hypofractionated or conventionally fractionated.
This is a multicentric, randomized, prospective Phase II intervention trial. Efficacy is measured as the rate in patients with PSA progression one year after randomization (defined as PSA nadir after randomization +2 ng/ml). There is a 2:1 randomization between intervention and observation group. Patients with PSA progression in the observation group are offered a new diagnosis. This should preferably correspond to the initial diagnosis. Therapy is performed for all patients in the intervention arm using high dose radiation therapy, either as conventional fractional irradiation with 2 Gy/fraction up to a total dose of 50 Gy or as hypofractional irradiation with a single dose of 10 Gy up to a total dose of 30 Gy. The decision as to which regimen the patient is to be treated according to is made by the treating physician, taking into account in particular the location of the volume to be irradiated in relation to the organs at risk and any previous irradiation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Within the scope of the study, irradiation with two irradiation schemes is possible (the scheme applied is recorded in the CRF): * Scheme A 3\*10 Gy (once a day, 2-3 days a week) * Scheme B 25\*2 Gy (once a day, 5 days a week) The decision which irradiation scheme (3\*10 Gy or 25\*2 Gy) to use is made by the treating physician based on the anatomical position, the size of the metastases and the expected normal tissue load. Hypofractionated irradiation in three fractions is only possible if the limit values for the risk organs are adhered to. Radiotherapy should be performed with photons.
Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden
Dresden, Saxony, Germany
University Medical Center Freiburg, Department of Radiation Oncology
Freiburg im Breisgau, Germany
University Hospital Heidelberg, Department of Radiation Oncology
Heidelberg, Germany
University Clinic Tübingen, Clinic for Radiation Oncology
Tübingen, Germany
Time to PSA progression
Time to PSA progression (defined as PSA nadir after randomization +2ng/ml)
Time frame: 12 month after randomization
Change of PSA doubling time
PSA doubling time measured with the last three consecutive PSA values. Change of PSA doubling time compared to value before treatment
Time frame: 12 month after randomization
Number of patients without detection of new lesions
Number of patients without detection of new lesions at 12 months
Time frame: 12 month after randomization
Toxicity (CTCAE 5.0)
description of toxicity (CTCAE 5.0) ant 3 and 12 months.
Time frame: 3 and 12 month after therapy
Number of patients who have PSA response
Number of patients who have a PSA reduction of \>50% at 12 months.
Time frame: 12 month after randomization
Time to tumor-specific systemic therapy after intervention
Time to tumor-specific systemic therapy after intervention (i.e. chemotherapy)
Time frame: 12 month after randomization
Number of patients with a limited number of metastases at PSA progression
Number of patients with a limited number of metastases at PSA progression, compared to patients with multiple metastases. (Arm B only)
Time frame: 12 month after randomization
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