Fluciclovine (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study

• Status: Recruiting
• Trial end date: 2028-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborators: Blue Earth Diagnostics; National Cancer Institute (NCI)
• Treatments: Abiraterone Acetate; Prednisone

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

• 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