18F-fluciclovine PET in Metastatic Castration Resistant Prostate Cancer Treated With Life Prolonging Therapies

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

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

Details

• Lead Sponsor: Tulane University
• Collaborator: Blue Earth Diagnostics
• Treatments: Abiraterone Acetate

Criteria

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.