Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06101290

Locally Ablative Therapy in Oligo-Progressive Genitourinary Tumors (LAYOVER)

Led by University of California, Davis · Updated on 2024-12-18

150

Participants Needed

1

Research Sites

265 weeks

Total Duration

On this page

Sponsors

U

University of California, Davis

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to assess the clinical benefit of continuing systemic therapy combined with locally ablative therapies for patients with oligo-progressive solid tumors, specifically genitourinary cancers such as prostate cancer, urothelial carcinoma, and renal cell carcinoma. The primary goal is to measure disease control at 3 months, defined as ongoing systemic therapy without changes or permanent discontinuation following local ablative treatment. This is a phase 2 pragmatic study conducted at a single site. Participants will receive locally ablative therapy, which may include stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation, in addition to their current systemic therapy. The specific ablative therapy will be selected by the treating radiation oncologist or interventional radiologist. Participants must be on systemic therapy and able to continue it with no more than a 30-day break to allow for ablative treatment. The study will follow participants for up to 5 years after the first day of ablative local therapy. During the study, participants will be monitored for disease control, adverse events related to ablative therapy, overall survival, and time to treatment failure for up to 1 to 2 years depending on the measure. Researchers will assess disease status at 3 months post-treatment and track any grade 3 or higher adverse events. Follow-up evaluations and clinical assessments will occur regularly to observe the effects and safety of combining systemic therapy with locally ablative treatments.

CONDITIONS

Brief Title

Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must have a confirmed diagnosis of one of the following genitourinary cancers: prostate cancer, urothelial carcinoma, or renal cell carcinoma
  • Age 18 years or older at the time of consent
  • Currently receiving systemic therapy with the ability to continue it with no more than a 30-day break
  • At least one line of systemic therapy for metastatic disease with clinical benefit for 3 months or more on the most recent therapy
  • Have 5 or fewer progressing or new metastatic lesions
  • All progressing or new metastatic lesions can be safely treated with locally ablative therapies
  • Willingness to comply with all study procedures and availability for the study duration
  • Signed and dated informed consent form
Not Eligible

You will not qualify if you...

  • Medical conditions that prevent receiving locally ablative therapies
  • History of treatment-related toxicities limiting or prohibiting locally ablative therapies
  • Presence of progressing intracranial lesions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 3 months

Participants receive stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy in addition to continuing their systemic therapy.

Visits as needed per local ablative therapy standards

Long-term Monitoring

Duration - Up to 5 years

Participants are followed for safety, disease control, and survival outcomes after ablative local therapy.

Periodic follow-up visits over 5 years

Trial Site Locations

Total: 1 location

1

University of California, Davis

Sacramento, California, United States, 95817

Actively Recruiting

Loading map...

Research Team

S

Selina Laqui

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Similar Trials

177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With...

Prostate Cancer

Actively Recruiting

1 location

A Phase 1b Study of 177Lu-PSMA-617 Combined With Liver Direc...

Metastatic Prostate Cancer

Actively Recruiting

1 location

18F-PSMA-1007 PET/CT Imaging in Prostate Cancer Phase III Ac...

Prostate Cancer

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here