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TERPS Trial for de Novo Oligometastic Prostate Cancer
NCT05223803 · University of Maryland, Baltimore
In plain English
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Official title
Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in de Novo oligometaStatic Prostate Cancer (TERPS) Trial
About this study
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 criteria
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.
Study design
Enrollment target: 122 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-10-18
Estimated completion: 2027-07-31
Last updated: 2025-11-10
Interventions
Radiation: Prostate radiation (XRT)Drug: Systemic TherapyRadiation: Stereotactic ablative radiation therapy (SABR)
Primary outcomes
- • To determine the 2-year failure-free survival (FFS) of men who have oligometastatic prostate cancer with BST+XRT versus BST+XRT+SABR MDT. (2 years)
Sponsor
University of Maryland, Baltimore · other
Contacts & investigators
ContactPhuoc Tran, MD · contact · Phuoc.Tran@umm.edu · 410-369-5200
ContactNicole Helie · contact · nicole.helie@umm.edu · 410-328-6304
All locations (9)
UC San Diego Moores Cancer CenterRecruiting
La Jolla, California, United States
Maryland Proton Treatment CenterRecruiting
Baltimore, Maryland, United States
UMMCRecruiting
Baltimore, Maryland, United States
Upper Chesapeake HealthNot Yet Recruiting
Bel Air, Maryland, United States
Central Maryland Radiation OncologyRecruiting
Columbia, Maryland, United States
Baltimore Washington Medical CenterRecruiting
Glen Burnie, Maryland, United States
Sidney Kimmel Cancer Center at Jefferson HealthRecruiting
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
Bon Secours Cancer Institute at St. FrancisRecruiting
Midlothian, Virginia, United States