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

NCT04158245 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BED-IIT-382
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Changes in 18F-fluciclovine PET Scan for Patients With mCRPC on Treatment With Life Prolonging Therapies

  To describe the 18F-fluciclovine PET findings for patients with mCRPC prior to starting treatment with Life Prolonging Therapies, and at 12 weeks after Life Prolonging Therapies treatment initiation. We have 4 categories that can be seen in the scan to measure the metabolic response using PERSIST 1.1, 1)stable disease, 2)progressive disease, 3)partial response and 4)complete response.

  12 weeks

• PET Scan vs. Conventional CT and Bone Scan

  A comparison of 18F-fluciclovine PET with conventional CT and bone scans for patients with mCRPC prior to starting treatment with life prolonging therapies, and at 12 weeks after starting life prolonging therapies; and to correlate these changes with PSA response and progression after starting life prolonging therapies.

  12 weeks

Study Arms (1)

18F-fluciclovine PET Scan

EXPERIMENTAL

Single intravenous administration of 18F-fluciclovine for PET Scan.

Drug: 18F-fluciclovine PET Scan

Interventions

18F-fluciclovine PET Scan DRUG

The use of 18F-fluciclovine PET scanning will allow a more sensitive assessment of mCRPC patients at the initiation of systemic therapy and changes observed in 18F-fluciclovine PET will correlate better with the serologic changes in PSA, allowing superior disease monitoring, as compared to conventional imaging modalities. In addition, 18F-fluciclovine PET will detect heterogeneity in disease response and thus identify potential lesions amenable to targeted therapy.

Also known as: Axumin

18F-fluciclovine PET Scan

Eligibility Criteria

• Age: 18 Years - 18 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2;
• Age ≥ 18 years;
• Histologically confirmed adenocarcinoma of the prostate;
• Ongoing use of luteinizing hormone-releasing hormone (LHRH) required in the absence of surgical castration and castrate concentration of testosterone (\< 50 ng/dL);
• Detectable PSA of at least 2 ng/dL;
• Metastatic disease documented by CT or bone scan within 42 days of cycle 1 day 1;
• Life expectancy of ≥ 6 months;
• 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;
• No prior life-prolonging therapies for mCRPC are allowed, except Sipuleucel-T;
• The use of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting is allowed;
• Low dose prednisone (10 mg or less) or equivalent is allowed;
• Acceptable liver function (within 28 days from enrollment) defined as:

You may not qualify if:

• Pathological findings consistent with small cell carcinoma of the prostate;
• Prior treatment with docetaxel for metastatic castration-resistant prostate cancer (CRPC);
• Patient with normal 18F-flucicolovine PET/CT scans at baseline;
• Know allergies, hypersensitivity, or intolerance to abiraterone, prednisone, 18F-fluciclovine or their excipients;
• Any chronic medical condition requiring ≥ 10 mg daily of systemic prednisone (or equivalent);
• Major surgery (e.g., required general anesthesia) within 2 weeks before screening;
• 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;
• Evidence of other metastatic malignancies within the last year;
• 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.

Sponsors & Collaborators

• Tulane University: lead
• Blue Earth Diagnostics: collaborator

Study Sites (1)

Tulane Cancer Center Clinic

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Interventions

fluciclovine F-18

Results Point of Contact

• Title: Brian Lewis
• Organization: Tulane University

blewis@tulane.edu

504-988-6300

Study Officials

• Brian Lewis, MD, MPH, FACP

  Tulane University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: January 30, 2020
• Primary Completion: September 30, 2022
• Study Completion: April 3, 2023
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)