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

Sponsor
University Hospital Tuebingen
Study ID
NCT07644754
Status
Not Yet Recruiting

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Conditions

  • Prostate Cancer
  • Prostate Cancer Metastatic Disease
  • Prostate Cancer Metastatic to Bone

Eligibility Criteria

Sex
MALE
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Radiotherapy to the prostate and to PSMA-PET positive metastases — RADIATION
    Patients will receive radiotherapy to the prostate and to PSMA-PET postivie Metastases

Study Details

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

Key Dates

First listed
Jun 12, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Feb 28, 2031

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Radiotherapy to the prostate and PSMA-PET/CT guided radiotherapy of refractory metastases
    Radiotherapy to the prostate and refractory metastases on PSMA-PET/CT

Primary Outcome Measure

Radiological Progression-Free Survival [ Time Frame: 12 months after radiotherapy of metastases ]

Central Contacts

  • Elgin Hoffmann, MD, Dr. med.
    4970712982165
    [email protected]
  • Maximilian Niyazi, MD, Prof. Dr. Dipl.-Phys.

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