Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
122 participants
INTERVENTIONAL
2022-10-18
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Best systemic therapy (BST) + primary prostate radiation (XRT)
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.
BST + XRT + SABR metastasis-directed therapy (MDT)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
MALE
No
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Department of Radiation Oncology
Principal Investigator
Locations
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UC San Diego Moores Cancer Center
La Jolla, California, United States
Maryland Proton Treatment Center
Baltimore, Maryland, United States
UMMC
Baltimore, Maryland, United States
Upper Chesapeake Health
Bel Air, Maryland, United States
Central Maryland Radiation Oncology
Columbia, Maryland, United States
Baltimore Washington Medical Center
Glen Burnie, Maryland, United States
Sidney Kimmel Cancer Center at Jefferson Health
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Bon Secours Cancer Institute at St. Francis
Midlothian, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Tyler Seibert, MD, PhD
Role: primary
Nicole Helie
Role: primary
Nicole Helie
Role: primary
Lalicia Roman
Role: primary
Caitlin Eggleston
Role: primary
Pilar Strycula, RN, BSN
Role: primary
Jessie DiNome, MD
Role: primary
Adam Olson, MD
Role: primary
Joseph Pennington, MD
Role: primary
Other Identifiers
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HP-00098826
Identifier Type: -
Identifier Source: org_study_id