Clinical trial · Interventional
Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER)
NCT06101290CI-TRIAL-00116390LAYOVERrecruitingN/AClinicalTrials.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 is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oligoprogressive | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ablative local therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ablative local therapy
- description
- Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy
- interventionNames
- Device: Ablative local therapy
Primary outcomes (1)
- measure
- Number of participants with controlled disease
- timeFrame
- 3 months from the first day of ablative local therapy
- description
- Number of participants with controlled disease at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy
Secondary outcomes (3)
- measure
- Number of participants experiencing grade ≥ 3 adverse events attributable to ablative local therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies: 1. Cohort A: prostate cancer 2. Cohort B: urothelial carcinoma 3. Cohort C: renal cell carcinoma 2. Provision of signed and dated informed consent form. 3. Stated willingness to comply with all study procedures and availability for the duration of the study. 4. Age ≥18 years at time of consent. 5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy. 6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\] 7. ≤ 5 progressing or new metastatic lesions. 8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist. Exclusion Criteria: 1. Medical comorbidities precluding locally ablative therapies. 2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies. 3. Progressing intracranial lesions.
References
Publications (0)
Data not yet available
No reference posted for this study.