Phase
Condition
Prostate Disorders
Urologic Cancer
Prostate Cancer, Early, Recurrent
Treatment
Prostate radiation (XRT)
Systemic Therapy
Stereotactic ablative radiation therapy (SABR)
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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.
CT or MRI scan within 6 months of enrollment
Bone scan within 6 months of enrollment
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)
Histologic confirmation of malignancy (primary or metastatic tumor).
Patient may have had prior systemic therapy and/or ADT associated with treatmentwithin 9-months of enrollment.
PSA > 0.5 but <100.
Patient must be ≥ 18 years of age.
Patient must have a life expectancy ≥ 12 months.
Patient must have an ECOG performance status ≤ 2.
Patient must have the ability to understand and the willingness to sign a writteninformed consent document
Exclusion
Exclusion Criteria:
Castration-resistant prostate cancer (CRPC).
Prior radiation therapy to an overlapping site of a target lesion that wouldpreclude further radiation therapy
Spinal cord compression or impending spinal cord compression.
Suspected pulmonary and/or liver metastases (greater >10 mm in largest axis).
Patient receiving any other investigational agents.
Inability to receive any form of systemic therapy in the opinion of a treatingmedical oncologist .
Unable to lie flat during or tolerate PET/MRI, PET/CT or SABR.
No radiographical evidence of cranial metastasis.
Refusal to sign informed consent.
Study Design
Study Description
Connect with a study center
UC San Diego Moores Cancer Center
La Jolla, California 92093
United StatesSite Not Available
UC San Diego Moores Cancer Center
La Jolla 5363943, California 5332921 92093
United StatesActive - Recruiting
Maryland Proton Treatment Center
Baltimore, Maryland 21201
United StatesSite Not Available
UMMC
Baltimore, Maryland 21201
United StatesActive - Recruiting
Upper Chesapeake Health
Bel Air, Maryland 21014
United StatesSite Not Available
Central Maryland Radiation Oncology
Columbia, Maryland 21044
United StatesSite Not Available
Baltimore Washington Medical Center
Glen Burnie, Maryland 21061
United StatesSite Not Available
Maryland Proton Treatment Center
Baltimore 4347778, Maryland 4361885 21201
United StatesActive - Recruiting
UMMC
Baltimore 4347778, Maryland 4361885 21201
United StatesActive - Recruiting
Upper Chesapeake Health
Bel Air 4348240, Maryland 4361885 21014
United StatesSite Not Available
Central Maryland Radiation Oncology
Columbia 4352053, Maryland 4361885 21044
United StatesActive - Recruiting
Baltimore Washington Medical Center
Glen Burnie 4356188, Maryland 4361885 21061
United StatesActive - Recruiting
Sidney Kimmel Cancer Center at Jefferson Health
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
Sidney Kimmel Cancer Center at Jefferson Health
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesActive - Recruiting
UPMC Hillman Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927 15232
United StatesActive - Recruiting
Bon Secours Cancer Institute at St. Francis
Midlothian, Virginia 23114
United StatesSite Not Available
Bon Secours Cancer Institute at St. Francis
Midlothian 4772943, Virginia 6254928 23114
United StatesActive - Recruiting

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