Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in de Novo oligometaStatic Prostate Cancer (TERPS) Trial
University of Maryland, Baltimore
Summary
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.
Description
This study will compare the effects, good and/or bad, of using the standard of care treatment (systemic therapy + primary prostate radiation) compared to standard of care treatment plus stereotactic ablative radiation therapy (SABR) to metastatic lesions for prostate patients. The researchers are also trying to learn if the addition of SABR will affect recurrence rates. Presence of circulating tumor cells, gut bacteria, and quality of life will be assessed for both groups.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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 alternati…
Interventions
- RadiationProstate radiation (XRT)
Both arms will receive prostate radiation. Multiple treatment regimens are allowed per protocol.
- DrugSystemic Therapy
All systemic therapy is provided as best prescribed for patient per their medical oncologist.
- RadiationStereotactic ablative radiation therapy (SABR)
SABR is delivered to those randomized to Arm 2.
Locations (9)
- UC San Diego Moores Cancer CenterLa Jolla, California
- Maryland Proton Treatment CenterBaltimore, Maryland
- UMMCBaltimore, Maryland
- Upper Chesapeake HealthBel Air, Maryland
- Central Maryland Radiation OncologyColumbia, Maryland
- Baltimore Washington Medical CenterGlen Burnie, Maryland