TERPS Trial for de Novo Oligometastic Prostate Cancer

Last updated: November 5, 2025
Sponsor: University of Maryland, Baltimore
Overall Status: Active - Recruiting

Phase

2

Condition

Prostate Disorders

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

Prostate radiation (XRT)

Systemic Therapy

Stereotactic ablative radiation therapy (SABR)

Clinical Study ID

NCT05223803
HP-00098826
  • Ages > 18
  • Male

Study 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

Inclusion Criteria:

  1. Patient must have at least one and up to three asymptomatic metastatic tumor(s) ofthe 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 advancedfunctional imaging such as fluciclovine (Axumin), choline or PSMA PET-CT scan.

  2. CT or MRI scan within 6 months of enrollment

  3. Bone scan within 6 months of enrollment

  4. Fluciclovine (Axumin), choline, or PSMA PET-CT scan within 6 months ofenrollment (PET-CT scan is reasonable for study entry imaging as an alternativeto CT/MRI scan and bone scan)

  5. Histologic confirmation of malignancy (primary or metastatic tumor).

  6. Patient may have had prior systemic therapy and/or ADT associated with treatmentwithin 9-months of enrollment.

  7. PSA > 0.5 but <100.

  8. Patient must be ≥ 18 years of age.

  9. Patient must have a life expectancy ≥ 12 months.

  10. Patient must have an ECOG performance status ≤ 2.

  11. Patient must have the ability to understand and the willingness to sign a writteninformed consent document

Exclusion

Exclusion Criteria:

  1. Castration-resistant prostate cancer (CRPC).

  2. Prior radiation therapy to an overlapping site of a target lesion that wouldpreclude 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 treatingmedical 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 Design

Total Participants: 122
Treatment Group(s): 3
Primary Treatment: Prostate radiation (XRT)
Phase: 2
Study Start date:
October 18, 2022
Estimated Completion Date:
July 31, 2027

Study 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.

Connect with a study center

  • UC San Diego Moores Cancer Center

    La Jolla, California 92093
    United States

    Site Not Available

  • UC San Diego Moores Cancer Center

    La Jolla 5363943, California 5332921 92093
    United States

    Active - Recruiting

  • Maryland Proton Treatment Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • UMMC

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Upper Chesapeake Health

    Bel Air, Maryland 21014
    United States

    Site Not Available

  • Central Maryland Radiation Oncology

    Columbia, Maryland 21044
    United States

    Site Not Available

  • Baltimore Washington Medical Center

    Glen Burnie, Maryland 21061
    United States

    Site Not Available

  • Maryland Proton Treatment Center

    Baltimore 4347778, Maryland 4361885 21201
    United States

    Active - Recruiting

  • UMMC

    Baltimore 4347778, Maryland 4361885 21201
    United States

    Active - Recruiting

  • Upper Chesapeake Health

    Bel Air 4348240, Maryland 4361885 21014
    United States

    Site Not Available

  • Central Maryland Radiation Oncology

    Columbia 4352053, Maryland 4361885 21044
    United States

    Active - Recruiting

  • Baltimore Washington Medical Center

    Glen Burnie 4356188, Maryland 4361885 21061
    United States

    Active - Recruiting

  • Sidney Kimmel Cancer Center at Jefferson Health

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Sidney Kimmel Cancer Center at Jefferson Health

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Active - Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh 5206379, Pennsylvania 6254927 15232
    United States

    Active - Recruiting

  • Bon Secours Cancer Institute at St. Francis

    Midlothian, Virginia 23114
    United States

    Site Not Available

  • Bon Secours Cancer Institute at St. Francis

    Midlothian 4772943, Virginia 6254928 23114
    United States

    Active - Recruiting

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