Changes in 18F-fluciclovine Positron Emission Tomography (PET) in Patients With Metastatic Castration Resistant Prostate Cancer Treated With With Life Prolonging Therapies: A Pilot Study

BED-IIT-382

This is a pilot phase 2 single-arm study, of men with metastatic castration-resistant prostate cancer (mCRPC). Patients will be treated with any of the approved life-prolonging therapies: abiraterone 1000 mg daily plus prednisone 5 mg (or dexamethasone 0.5 mg) daily, enzalutamide 160 mg daily, or docetaxel 50 mg/m2 every two weeks or 75 mg/m2 every three weeks.

2020-01-30

2022-09-30

2023-04-03

Completed

Early phase I

10

Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2; 2. Age ≥ 18 years; 3. Histologically confirmed adenocarcinoma of the prostate; 4. Ongoing use of luteinizing hormone-releasing hormone (LHRH) required in the absence of surgical castration and castrate concentration of testosterone (\< 50 ng/dL); 5. Detectable PSA of at least 2 ng/dL; 6. Metastatic disease documented by CT or bone scan within 42 days of cycle 1 day 1; 7. Life expectancy of ≥ 6 months; 8. Must have disease progression despite a castrate concentration of testosterone of \< 50 ng/dL based on: A. PSA progression defined as increase in PSA of at least 2 ng/dL and 25% from nadir values of prior therapy, determined by 2 separate measurement taken at least 1 week apart; And/or B. Radiographic disease progression based on response evaluation criteria in solid tumors (RECIST) 1.1 for soft tissue disease and/or prostate cancer working group 3 (PCWG3) for bone only disease; 9. No prior life-prolonging therapies for mCRPC are allowed, except Sipuleucel-T; 10. The use of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting is allowed; 11. Low dose prednisone (10 mg or less) or equivalent is allowed; 12. Acceptable liver function (within 28 days from enrollment) defined as: A. Bilirubin \< 2.5 times upper limit of normal (ULN), except for patients with known Gilbert disease (in such cases bilirubin \< 5 times ULN); B. AST (SGOT) and ALT (SGPT) \< 3 times ULN 13. Acceptable renal function (within 28 days from enrollment): A. Serum creatinine ≤ 2.0 x ULN or creatinine clearance ≥ 30 mL/min 14. Acceptable hematologic status (within 28 days from enrollment): A. Absolute neutrophil count (ANC) ≥ 1000 cell/mm3 (100 x 109/L) B. Platelet count ≥ 100,000 platelet/mm3 (100 x 109/L) C. Hemoglobin ≥ 9 g/dL 15. At least 2 weeks since prior radiation before starting study treatment (cycle 1 day 1); 16. Able to understand and willing to sign a written informed consent document; 17. Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last dose of abiraterone acetate. Exclusion Criteria: 1. Pathological findings consistent with small cell carcinoma of the prostate; 2. Prior treatment with docetaxel for metastatic castration-resistant prostate cancer (CRPC); 3. Patient with normal 18F-flucicolovine PET/CT scans at baseline; 4. Know allergies, hypersensitivity, or intolerance to abiraterone, prednisone, 18F-fluciclovine or their excipients; 5. Any chronic medical condition requiring ≥ 10 mg daily of systemic prednisone (or equivalent); 6. Major surgery (e.g., required general anesthesia) within 2 weeks before screening; 7. Uncontrolled active infection (including hepatitis B or C or AIDS). Patients with hepatitis B/C who have disease under control and no significant liver function impairment, and undetectable viral load will be allowed to participate. Similarly, patients with known HIV and ≥ 400 CD4 + T cells are allowed to participate; 8. Evidence of other metastatic malignancies within the last year; 9. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Describe the changes in the 18F-fluciclovine Positron Emission Tomography (PET) in patients with metastatic castration resistant prostate cancer treated with abiraterone acetate-prednisone, enzalutamide or docetaxel.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}

2023-04-24