Clinical Trial

Patients With Metastasized Prostate Cancer Whose Prostate-specific Antigen-level (PSA) Remains >0,2 ng/ml After Six Months of Dual Antihormonal Therapy Will Receive Radiotherapy to the Prostate and Radiotherapy to Refractory Metastases

Study acronym: RIALTO
Not Yet Recruiting
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Summary
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
Trial Details
NCT Number NCT07644754
Lead Sponsor University Hospital Tuebingen
Collaborators: Ludwig-Maximilians - University of Munich, University Hospital Freiburg, University Hospital Dresden, Uniklinikum Giessen und Marburg, University Hospital Augsburg
Conditions Prostate Cancer, Prostate Cancer Metastatic Disease, Prostate Cancer Metastatic to Bone
Enrollment 27 participants
Start Date 2026-07
Primary Completion 2027-07 (estimated)
Study Completion 2031-02 (estimated)
Updated on ClinicalTrials.gov 2026-06-12