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

Condition: Metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04158245

Sponsor: Tulane University

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum 18 Years
• Gender: Male

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.

View trial on ClinicalTrials.gov