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RecruitingInterventionalPhase 2

Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in de Novo oligometaStatic Prostate Cancer (TERPS) Trial

NCT ID: NCT05223803Sponsor: University of Maryland, BaltimoreLast updated: 2026-06-03

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.

Detailed 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.

Arms & 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.

Outcome measures

Primary

  • To determine the 2-year failure-free survival (FFS) of men who have oligometastatic prostate cancer with BST+XRT versus BST+XRT+SABR MDT.

    Cross-over to the SABR MDT is allowed following failure.

    Time frame: 2 years

Secondary

  • To determine the number of participants with toxicities related to SABR MDT in patients with de novo oligometastatic disease

    Time frame: 5 years

  • To determine local control at 12-months after SABR MDT in patients with de novo oligometastatic disease.

    Time frame: 1 year

  • To assess time to progression

    Time frame: 5 years

  • Quality of life assessed through EPIC tool utilizing patient scores in each function group following completion of SABR MDT.

    Time frame: 5 years

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy 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 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 locations (10)

UC San Diego Moores Cancer Center

La Jolla, California, 92093

Recruiting
Tyler Seibert, MD, PhD · Contact

KU Medical Center- Cancer Center

Kansas City, Kansas, 66160

Recruiting
Xinglei Shen, MD · Contact

Maryland Proton Treatment Center

Baltimore, Maryland, 21201

Recruiting
Nicole Helie · Contact

UMMC

Baltimore, Maryland, 21201

Recruiting
Nicole Helie · Contact

Upper Chesapeake Health

Bel Air, Maryland, 21014

Recruiting
Lalicia Roman · Contact

Central Maryland Radiation Oncology

Columbia, Maryland, 21044

Recruiting
Caitlin Eggleston · Contact

Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061

Recruiting
Pilar Strycula, RN, BSN · Contact

Sidney Kimmel Cancer Center at Jefferson Health

Philadelphia, Pennsylvania, 19107

Recruiting
Jessie DiNome, MD · Contact

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Recruiting
Adam Olson, MD · Contact

Bon Secours Cancer Institute at St. Francis

Midlothian, Virginia, 23114

Recruiting
Joseph Pennington, MD · Contact
TERPS Trial for de Novo Oligometastic Prostate Cancer | Cancerify