Clinical trial · Interventional
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
RIALTO: Radiotherapy in Primarily Metastasized Prostate Cancer - Image-guided Local AbLaTion of Prostate and Oligoresidual Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer Metastatic Disease | — | UNRESOLVED | — |
| Prostate Cancer Metastatic to Bone | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy to the prostate and to PSMA-PET positive metastases | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy to the prostate and PSMA-PET/CT guided radiotherapy of refractory metastases
- description
- Radiotherapy to the prostate and refractory metastases on PSMA-PET/CT
- interventionNames
- Radiation: Radiotherapy to the prostate and to PSMA-PET positive metastases
Primary outcomes (1)
- measure
- Radiological Progression-Free Survival
- timeFrame
- 12 months after radiotherapy of metastases
- description
- Radiological Progression-Free Survival as determined on PSMA-PET/CT according to RECIP criteria, defined as 30% response in PSA-volume
Secondary outcomes (9)
- measure
- Lesion-specific response on imaging
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available