Clinical trial · Interventional
Single Dose Radiotherapy (SDRT) With or Without Adjuvant Systemic Therapy for Oligometastatic Prostate Cancer
Phase II Randomized Study to Ablate Oligometastatic Prostate Cancer by Single Dose Radiotherapy (SDRT) With or Without Adjuvant Systemic Therapy and to Characterize Its Molecular Phenotype
- 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 present study aims to optimize the use of systemic therapy relative to local tumor ablation in a prospective randomized clinical trial and to validate the existence and characterize the clinical and pathology phenotype of oligometastatic (OM) prostate cancer (OM-PCa). For local tumor ablation we propose to use the novel non-invasive and highly effective technique of Image-Guided Single Dose Radiotherapy (SDRT), which we showed is capable of conferring long-term local relapse-free rates in ≥ 90% of metastatic PCa lesions. Concomitantly, we will develop, validate and implement a diagnostic algorithm for OM-PCa and functionally characterize Prostate Cancer Stem Cells (pCSCs) from human samples to correlate their molecular phenotypes with tumor response to treatment. The long-term aim is to define the indications, standardization of treatment protocols and outcome for OM-PCa. Response assessment will be via local control, metastasis-free survival and overall survival rates. Cases displaying the clinical OM phenotype, as disclosed via long-term disease remission following tumor ablation, will represent the basis to identify the molecular signatures of OM-PCa. These signatures will be used to develop and validate an algorithm to predict the OM phenotype upfront and define the treatment strategy that may lead to cure.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single Dose Radiotherapy (24 Gy) to all detectable lesions followed by adjuvant systemic therapy for 6 months | Drug | — | UNRESOLVED |
| Single Dose Radiotherapy (24 Gy) to all detectable lesions, followed by observation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Single Dose Radiotherapy (24 Gy) to all detectable lesions, followed by observation using PET/CT imaging studies every 6 months
- interventionNames
- Radiation: Single Dose Radiotherapy (24 Gy) to all detectable lesions, followed by observation
- type
- EXPERIMENTAL
- label
- B
- description
- Single Dose Radiotherapy (24 Gy) to all detectable lesions followed by adjuvant systemic therapy for 6 months stratified by whether disease is castrate-sensitive (mCS-PCa) or castrate-resistant (mCR-PCa)
- interventionNames
- Drug: Single Dose Radiotherapy (24 Gy) to all detectable lesions followed by adjuvant systemic therapy for 6 months
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic confirmation of adenocarcinoma of the prostate by biopsy confirmed by internal review; * 68Ga-PSMA or 18F-Choline PET/CT evidence of limited non-visceral (1-3 detectable foci) M1a-b metastases * All detectable lesions must be considered amenable for SDRT * Life expectancy \> 12 months * EGOG Performance Status 0-1 * Normal bone marrow functions as defined below: Hemoglobin ≥ 9 g/dl; Absolute Neutrophil count (ANC) ≥1500/ μl; Platelets ≥ 100,000 / μl * Signed study specific informed consent form Exclusion Criteria: * Overt polymetastatic disease (≥ 4 lesions or any visceral lesion) as shown by 68Ga-PSMA or 18F-Choline PET/CT * Previous radiation therapy for OM deposits * ECOG Performance status ≥2 * Severe, active co-morbidity * Significant psychiatric illness
References
Publications (0)
Data not yet available