NCT06101290 Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER)
| NCT ID | NCT06101290 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Davis |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-10-05 |
| Primary Completion | 2025-12-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2023-10-05 with a primary completion date of 2025-12-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Mamta Parikh, MD, MS
PRINCIPAL INVESTIGATOR
University of California, Davis
Frequently Asked Questions
Who can join the NCT06101290 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06101290 currently recruiting?
Yes, NCT06101290 is actively recruiting participants. Contact the research team at sblaqui@ucdavis.edu for enrollment information.
Where is the NCT06101290 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT06101290 clinical trial?
NCT06101290 is sponsored by University of California, Davis. The principal investigator is Mamta Parikh, MD, MS at University of California, Davis. The trial plans to enroll 150 participants.
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