Recruiting
Phase 2

TERPS

Sponsor:

University of Maryland, Baltimore

Code:

NCT05223803

Conditions

Prostate Cancer

Oligometastatic Disease

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prostate radiation (XRT)

Systemic Therapy

Stereotactic ablative radiation therapy (SABR)

Study Details

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.

Conditions

Prostate Cancer

Oligometastatic Disease

Study ID

NCT05223803

Start date

Oct 18, 2022

Status verified date

May, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

122 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Best systemic therapy (BST) + primary prostate radiation (XRT)

active comparator: BST + XRT + SABR metastasis-directed therapy (MDT)

Interventions

Prostate radiation (XRT)

Both arms will receive prostate radiation. Multiple treatment regimens are allowed per protocol.

Systemic Therapy

All systemic therapy is provided as best prescribed for patient per their medical oncologist.

Stereotactic ablative radiation therapy (SABR)

SABR is delivered to those randomized to Arm 2.

Primary outcome measure

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

Central Contacts and Locations

Locations

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

KU Medical Center- Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Maryland Proton Treatment Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

UMMC

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Upper Chesapeake Health

Recruiting

Bel Air, Maryland, United States, 21014

Contacts

Central Maryland Radiation Oncology

Recruiting

Columbia, Maryland, United States, 21044

Contacts

Baltimore Washington Medical Center

Recruiting

Glen Burnie, Maryland, United States, 21061

Contacts

Pilar Strycula, RN, BSN

410-553-8110Pstrycula@umm.edu

Sidney Kimmel Cancer Center at Jefferson Health

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Bon Secours Cancer Institute at St. Francis

Recruiting

Midlothian, Virginia, United States, 23114

Contacts

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Jun 3, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-06-03.