Prostate Specific Membrane Antigen (PSMA) or (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study

About This Trial

This study is testing whether advanced imaging scans can help doctors find small areas of returning prostate cancer early and guide targeted treatment directly to those spots.
It is designed for patients whose cancer blood marker (PSA) is rising again after having already completed both surgery and radiation therapy.
To participate, standard scans must show that the cancer has not widely spread, and you must have relatively good overall health.
Before considering this trial, you should know that you must be able to lie still during imaging sessions and weigh 300 pounds or less due to scanner limits.

This phase II trial studies how well prostate specific membrane antigen (PSMA) or fluciclovine positron emission tomography (PET)/computed tomography (CT) site-directed therapy works for treating patients with prostate cancer.
PSMA or fluciclovine PET/CT may detect prostate cancer early and may help to show whether patients benefit from site directed treatment to PET detected abnormalities.

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This study is testing whether advanced imaging scans can help doctors find small areas of returning prostate cancer early and guide targeted treatment directly to those spots.

Full Eligibility Criteria

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
Patient must have a prostate specific antigen (PSA) >= 0.2 and = 0.2 with this biochemical recurrence, a second PSA value must be confirmed to be within >= 0.2 and 0.1 ng/mL from most recent biochemically-recurred (BCR) or the most recent 3 PSA measurements > 0.1 ng/mL (if the latter, all 3 PSA measurements must be > 2 weeks apart to be used in the calculation). PSA doubling time must be > 3 months and 120 ng/dL demonstrated within 42 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) == 30 mL/min as estimated by the Cockcroft-Gault criteria or as determined by 24 hour Cr Cl measurement
Patient must be >= 18 years of age on day of signing informed consent
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 or PSMA 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