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NCT05223803PHASE2Recruiting

TERPS Trial for de Novo Oligometastic Prostate Cancer

University of Maryland, Baltimore

Start Date

10/18/2022

Completion Date

7/31/2029

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

RADIATION

Prostate radiation (XRT)

DRUG

Systemic Therapy

RADIATION

Stereotactic ablative radiation therapy (SABR)

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Conditions

Prostate CancerOligometastatic Disease

Locations

UC San Diego Moores Cancer Center

La Jolla, California 92093

United States

KU Medical Center- Cancer Center

Kansas City, Kansas 66160

United States

Maryland Proton Treatment Center

Baltimore, Maryland 21201

United States

UMMC

Baltimore, Maryland 21201

United States

Upper Chesapeake Health

Bel Air, Maryland 21014

United States

Central Maryland Radiation Oncology

Columbia, Maryland 21044

United States

Baltimore Washington Medical Center

Glen Burnie, Maryland 21061

United States

Sidney Kimmel Cancer Center at Jefferson Health

Philadelphia, Pennsylvania 19107

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

Bon Secours Cancer Institute at St. Francis

Midlothian, Virginia 23114

United States