TERPS Trial for De Novo Oligometastic Prostate Cancer

Description

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.

Conditions

Prostate Cancer, Oligometastatic Disease

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Study Overview

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Study Details

Study overview

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.

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

TERPS Trial for De Novo Oligometastic Prostate Cancer

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

La Jolla

UC San Diego Moores Cancer Center, La Jolla, California, United States, 92093

Baltimore

Maryland Proton Treatment Center, Baltimore, Maryland, United States, 21201

Baltimore

UMMC, Baltimore, Maryland, United States, 21201

Bel Air

Upper Chesapeake Health, Bel Air, Maryland, United States, 21014

Columbia

Central Maryland Radiation Oncology, Columbia, Maryland, United States, 21044

Glen Burnie

Baltimore Washington Medical Center, Glen Burnie, Maryland, United States, 21061

Philadelphia

Sidney Kimmel Cancer Center at Jefferson Health, Philadelphia, Pennsylvania, United States, 19107

Pittsburgh

UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States, 15232

Midlothian

Bon Secours Cancer Institute at St. Francis, Midlothian, Virginia, United States, 23114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Maryland, Baltimore,

Study Record Dates

2027-07-31