Prostate Cancer, Prostate Cancer Metastatic Disease, Prostate Cancer Metastatic to Bone
Conditions
Keywords
mHSPC, insufficient PSA-response to dual antihormonal treatment, local therapy, radiotherapy
Brief 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
Interventions
RADIATIONRadiotherapy to the prostate and to PSMA-PET positive metastases
Patients will receive radiotherapy to the prostate and to PSMA-PET postivie Metastases
Sponsors
University Hospital Tuebingen
Ludwig-Maximilians - University of Munich
University Hospital Freiburg
University Hospital Dresden
Uniklinikum Giessen und Marburg
University Hospital Augsburg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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 * multimetastasized disease stage without visceral metastases on imaging at first diagnosis (PET, CT, or bone scan) * \<16 osseous/lymphnodal metastases on response assessment imaging (PSMA-PET/CT) after six months of combined antihormonal therapy
Exclusion criteria
* neuroendocrine histology * visceral metastases (M1c) * prior radiotherapy to the pelvis * PSA \< 0,2 ng/ml after 6 months of combined antihormonal therapy * prior prostatectomy * contraindication against PSMA-PET/CT and/or radiotherapy to the prostate/metastases * HIFU or TUR-P within 6 months of study treatment * other active malignancy two years prior to study inclusion (except skin cancer in remission) * relevant GU/GI condition (active fistula or other) * known tumor predisposition syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiological Progression-Free Survival | 12 months after radiotherapy of metastases | Radiological Progression-Free Survival as determined on PSMA-PET/CT according to RECIP criteria, defined as 30% response in PSA-volume |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion-specific response on imaging | 12 months after radiotherapy to metastases | — |
| Prostate specific antigen (PSA) | up to 36 months after radiotherapy to the prostate | Prostate specific antigen |
| Objective response rate | 12 months after radiotherapy to metastases | — |
| Time to next systemic therapy | up to 36 months after radiotherapy to the prostate | — |
| Overall survival | up to 36 months after radiotherapy to the prostate | — |
| Failure-free survival | up to 36 months after radiotherapy to the prostate | — |
| Progression-free survival | up to 36 months after radiotherapy to the prostate | — |
| Metastasis-free survival | up to 36 months after radiotherapy to the prostate | — |
| Prostate-cancer specific survival | up to 36 months after radiotherapy to the prostate | — |
Contacts
CONTACTElgin Hoffmann, MD, Dr. med.
CONTACTMaximilian Niyazi, MD, Prof. Dr. Dipl.-Phys.
PRINCIPAL_INVESTIGATORElgin Hoffmann, MD
Department of Radiation Oncology, University Hospital Tübingen
Outcome results
None listed