Clinical trial · Interventional
TERPS Trial for de Novo Oligometastic Prostate Cancer
Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in de Novo oligometaStatic Prostate Cancer (TERPS) Trial
NCT05223803CI-TRIAL-00113498recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This research is being done to see if we can improve the outcome of prostate cancer patients who present with metastatic lesions at initial diagnosis.
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 |
|---|---|---|---|
| Oligometastatic Disease | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate radiation (XRT) | Radiation | — | UNRESOLVED |
| Stereotactic ablative radiation therapy (SABR) | Radiation | — | UNRESOLVED |
| Systemic Therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Best systemic therapy (BST) + primary prostate radiation (XRT)
- interventionNames
- Radiation: Prostate radiation (XRT)
- Drug: Systemic Therapy
- type
- ACTIVE_COMPARATOR
- label
- BST + XRT + SABR metastasis-directed therapy (MDT)
- interventionNames
- Radiation: Prostate radiation (XRT)
- Drug: Systemic Therapy
- Radiation: Stereotactic ablative radiation therapy (SABR)
Primary outcomes (1)
- measure
- To determine the 2-year failure-free survival (FFS) of men who have oligometastatic prostate cancer with BST+XRT versus BST+XRT+SABR MDT.
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone or soft tissue (with at least one bone metastasis) develop within the past 6-months that are seen on imaging. Up to five lesions are allowed on advanced functional imaging such as fluciclovine (Axumin), choline or PSMA PET-CT scan. 1. CT or MRI scan within 6 months of enrollment 2. Bone scan within 6 months of enrollment 3. Fluciclovine (Axumin), choline, or PSMA PET-CT scan within 6 months of enrollment (PET-CT scan is reasonable for study entry imaging as an alternative to CT/MRI scan and bone scan) 2. Histologic confirmation of malignancy (primary or metastatic tumor). 3. Patient may have had prior systemic therapy and/or ADT associated with treatment within 9-months of enrollment. 4. PSA \> 0.5 but \<100. 5. Patient must be ≥ 18 years of age. 6. Patient must have a life expectancy ≥ 12 months. 7. Patient must have an ECOG performance status ≤ 2. 8. Patient must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: 1. Castration-resistant prostate cancer (CRPC). 2. Prior radiation therapy to an overlapping site of a target lesion that would preclude further radiation therapy 3. Spinal cord compression or impending spinal cord compression. 4. Suspected pulmonary and/or liver metastases (greater \>10 mm in largest axis). 5. Patient receiving any other investigational agents. 6. Inability to receive any form of systemic therapy in the opinion of a treating medical oncologist . 7. Unable to lie flat during or tolerate PET/MRI, PET/CT or SABR. 8. No radiographical evidence of cranial metastasis. 9. Refusal to sign informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.