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
Prostate adenocarcinoma
de novo metastasized prostate cancer (at least 4 osseous metastases +/- lymphonodal metastases)
first-line combined antihormonal therapy (ADT + ARPI) for six months
PSA > 0,2 ng/ml after six months of combined ADT/ARPI therapy
neuroendocrine histology
visceral metastases (M1c)
prior radiotherapy to the pelvis
PSA < 0,2 ng/ml after 6 months of combined antihormonal therapy
Single group
Radiotherapy to the prostate and to PSMA-PET positive metastases
RadiationPatients 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
Lesion-specific response on imaging
Prostate specific antigen (PSA)
Prostate specific antigen
Objective response rate
Time to next systemic therapy
Quality of life questionnaires
EORTC QLQ-C30 Prostate
Organ-specific side effects
CTCAEv5
Organ function
IPS-Score
Choice of next systemic therapy
Documentation of systemic treatment in case of progression
Click on the lead sponsor to view all of their trials.
University Hospital Tuebingen
Lead sponsor
Ludwig-Maximilians - University of Munich
Collaborator
University Hospital Freiburg
Collaborator
University Hospital Dresden
Collaborator
Uniklinikum Giessen und Marburg
Collaborator
University Hospital Augsburg
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
