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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-85
SponsorUniversity Hospital Tuebingen

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

neuroendocrine histology

visceral metastases (M1c)

prior radiotherapy to the pelvis

PSA < 0,2 ng/ml after 6 months of combined antihormonal therapy

Trial design

Treatments tested in this trial

  • Radiotherapy to the prostate and to PSMA-PET positive metastases

Treatment groups

27 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

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