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RecruitingPhase 2NCT05223803

TERPS Trial for de Novo Oligometastic Prostate Cancer

Trial Parameters

ConditionProstate Cancer
SponsorUniversity of Maryland, Baltimore
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment122
SexMALE
Min Age18 Years
Max AgeN/A
Start Date2022-10-18
Completion2026-07-31
Interventions
Prostate radiation (XRT)Systemic TherapyStereotactic ablative radiation therapy (SABR)

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Brief 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.

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 th

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