Fluciclovine (FACBC) PET/CT Site-Directed Therapy of Oligometastatic Prostate Cancer (Flu-BLAST-PC)

Condition: Prostate Adenocarcinoma, PSA Level Greater Than or Equal to 0.5, PSA Level Less Than Ten

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04175431

Sponsor: University of Washington

Phase: Phase 2

Eligibility:

Inclusion Criteria:

Patient must have histologically or cytologically documented evidence of prostate adenocarcinoma
Patient must previously have undergone radical prostatectomy
Patient must previously have undergone either adjuvant or salvage radiation therapy to the prostatic fossa +/- whole pelvis
PSA doubling time must be calculated utilizing all PSA measurements from most recent biochemically-recurred (BCR). PSA doubling time must be > 3 months and < 18 months. The Memorial Sloan Kettering PSA doubling time calculator should be used
Patient must have no previous evidence of radiographically detectable metastatic prostate cancer by conventional CT and bone scan imaging
Patient must have total testosterone level > 120 ng/dL demonstrated within 28 days of enrollment
Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Absolute neutrophil count (ANC) >= 1.0 X 10^9/L
Platelet count >= 100 X 10^9/L
Hemoglobin >= 9 g/dL
Potassium >= 3.5
Serum bilirubin =< 1.5 X upper limit of normal (ULN) or =< 3 X ULN for patients with documented Gilbert's syndrome
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 X ULN
Creatinine clearance (Cr Cl) >= 30 mL/min as estimated by the Cockcroft-Gault criteria or as determined by 24 hour Cr Cl measurement
Patient must be able to understand and authorize informed consent

Exclusion Criteria:

Chronic active hepatitis B or C
History of a second, non-prostate malignancy that required systemic therapy in the last 2 years except cancer in situ of bladder and non-melanomatous cancers of the skin
Patient with a serious underlying medical condition that would otherwise impair the patient’s ability to undergo fluciclovine PET/CT imaging or receive subsequent treatment
Any condition that would alter the patient’s mental status, prohibiting understanding and/or authorization of informed consent
Expected lifespan of less than 12 weeks
Inability to lay still for imaging
Weight > 300 lbs. (due to equipment specifications)
Any other underlying medical condition that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and/or follow up