The goal of this clinical trial is to learn if radiotherapy to the prostate and PET-positive (positron emission tomography) metastasis will lead to radiological response on PSMA-PET (prostate specific membrane antigen-PET). Patients who receive combined androgen deprivation therapy for de novo metastasized prostate cancer and show an incomplete PSA-response (\>0,2 ng/ml after six months) and exhibit at least four bone metastases on PET-imaging at this time point (without metastases to organs) can take part in this study. The main questions it aims to answer are: • Does radiotherapy to the prostate and PET-positive metastases lead to a radiological response one year after radiotherapy? Researchers will analyze PET-imaging prior to radiotherapy to the prostate and metastases and one yeare thereafter. Participants will: * Continue taking combined androgen-deprivation therapy * Receive a total of three PSMA-PET/CT scans * Receive radiotherapy to the prostate and PET-positive metastases * Visit the clinic every three months for 36 months * Complete quality of life questionnaires at every visit
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
27
Patients will receive radiotherapy to the prostate and to PSMA-PET postivie Metastases
Radiological Progression-Free Survival
Radiological Progression-Free Survival as determined on PSMA-PET/CT according to RECIP criteria, defined as 30% response in PSA-volume
Time frame: 12 months after radiotherapy of metastases
Lesion-specific response on imaging
Time frame: 12 months after radiotherapy to metastases
Prostate specific antigen (PSA)
Prostate specific antigen
Time frame: up to 36 months after radiotherapy to the prostate
Objective response rate
Time frame: 12 months after radiotherapy to metastases
Time to next systemic therapy
Time frame: up to 36 months after radiotherapy to the prostate
Overall survival
Time frame: up to 36 months after radiotherapy to the prostate
Failure-free survival
Time frame: up to 36 months after radiotherapy to the prostate
Progression-free survival
Time frame: up to 36 months after radiotherapy to the prostate
Metastasis-free survival
Time frame: up to 36 months after radiotherapy to the prostate
Prostate-cancer specific survival
Time frame: up to 36 months after radiotherapy to the prostate
Maximilian Niyazi, MD, Prof. Dr. Dipl.-Phys.
CONTACT
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