TERPS Trial for de Novo Oligometastic Prostate Cancer

Recruiting now · Phase 2

Conditions studied: Prostate Cancer, Oligometastatic Disease

In brief

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.

Key facts

Study ID

NCT05223803

Run by

University of Maryland, Baltimore

People needed

122

Starts

2022-10-18

Expected to finish

2029-07-31

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• CT or MRI scan within 6 months of enrollment
• Bone scan within 6 months of enrollment
• 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)
• Histologic confirmation of malignancy (primary or metastatic tumor).
• Patient may have had prior systemic therapy and/or ADT associated with treatment within 9-months of enrollment.
• PSA > 0.5 but <100.
• Patient must be ≥ 18 years of age.
• Patient must have a life expectancy ≥ 12 months.
• Patient must have an ECOG performance status ≤ 2.
• Patient must have the ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

• Castration-resistant prostate cancer (CRPC).
• Prior radiation therapy to an overlapping site of a target lesion that would preclude further radiation therapy
• Spinal cord compression or impending spinal cord compression.
• Suspected pulmonary and/or liver metastases (greater >10 mm in largest axis).
• Patient receiving any other investigational agents.
• Inability to receive any form of systemic therapy in the opinion of a treating medical oncologist .
• Unable to lie flat during or tolerate PET/MRI, PET/CT or SABR.
• No radiographical evidence of cranial metastasis.
• Refusal to sign informed consent.

Where it is running

• UC San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
• KU Medical Center- Cancer Center — Kansas City, Kansas, United States (enrolling)
• Maryland Proton Treatment Center — Baltimore, Maryland, United States (enrolling)
• UMMC — Baltimore, Maryland, United States (enrolling)
• Upper Chesapeake Health — Bel Air, Maryland, United States (enrolling)
• Central Maryland Radiation Oncology — Columbia, Maryland, United States (enrolling)
• Baltimore Washington Medical Center — Glen Burnie, Maryland, United States (enrolling)
• Sidney Kimmel Cancer Center at Jefferson Health — Philadelphia, Pennsylvania, United States (enrolling)
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Bon Secours Cancer Institute at St. Francis — Midlothian, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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