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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00038018 | Registry Identifier | Deutsches Register Klinischer Studien (German clinical trial registry) |
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| Name | Class |
|---|---|
| Ludwig-Maximilians - University of Munich | OTHER |
| University Hospital Freiburg | OTHER |
| University Hospital Dresden | OTHER |
| Uniklinikum Giessen und Marburg |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy to the prostate and PSMA-PET/CT guided radiotherapy of refractory metastases | Experimental | Radiotherapy to the prostate and refractory metastases on PSMA-PET/CT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy to the prostate and to PSMA-PET positive metastases | Radiation | Patients will receive radiotherapy to the prostate and to PSMA-PET postivie Metastases |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months after radiotherapy of metastases |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion-specific response on imaging | 12 months after radiotherapy to metastases | |
| Prostate specific antigen (PSA) | Prostate specific antigen | up to 36 months after radiotherapy to the prostate |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life questionnaires | EORTC QLQ-C30 Prostate | up to 36 months after radiotherapy of the prostate |
| Organ-specific side effects | CTCAEv5 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elgin Hoffmann, MD, Dr. med. | Contact | 4970712982165 | ROinfo@med.uni-tuebingen.de | |
| Maximilian Niyazi, MD, Prof. Dr. Dipl.-Phys. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Elgin Hoffmann, MD | Department of Radiation Oncology, University Hospital Tübingen | Principal Investigator |
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Depending on national data security legislation for sharing individual data, providing IPD might not be permitted without explicit consent by the patients enrolled in this study.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 17, 2025 | Jun 1, 2026 |
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| University Hospital Augsburg | OTHER |
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| 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 |
| up to 36 months after radiotherapy of the prostate |
| Organ function | IPS-Score | up to 36 months after radiotherapy of the prostate |
| Choice of next systemic therapy | Documentation of systemic treatment in case of progression | up to 36 months after radiotherapy to the prostate |
| Reason for change in systemic therapy | Documentation in case of change in systemic therapy | up to 36 months after radiotherapy to the prostate |
| Quality of Life questionnaire | QLQ-PR25 | up to 36 months after end of radiotherapy of the prostate |
| Quality of life questionnaire | EQ-D5 | up to 36 months after radiotherapy to the prostate |
| Organ-specific side effects | RTOG questionnaire | up to 36 months after end of radiotherapy |
| Organ function | ICIQScore | up to 36 months after radiotherapy to the prostate |
| Organ-specific function | NCI-PRO-CTCAE | up to 36 months after radiotherapy to the prostate |
| Organ-specific function | IIEF | up to 36 months after radiotherapy to the prostate |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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