Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes
August 12, 2026 updated by: Ashesh B Jani, Emory University
Advanced PET-CT Directed Post-Prostatectomy Radiotherapy to Enhance Prostate Cancer Outcomes
This phase II trial studies how well a positron emission tomography (PET)/computed tomography (CT) scan using fluciclovine F18 compared with a PET/CT scan with 68Ga-PSMA works in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma.
Fluciclovine F18 and 68Ga-PSMA are types of tracers, called radiotracers, that are injected and can accumulate in tumor cells to develop images of them during a PET/CT scan.
It is not yet known whether giving fluciclovine F18 or 68Ga-PSMA may work better in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
PRIMARY OBJECTIVES
I. Improve the outcomes of post-prostatectomy radiotherapy prostate cancer patients via selection and treatment optimization with advanced molecular imaging with dose escalation.
II. Establish the role of advanced molecular imaging with fluciclovine F18 (fluciclovine [18F]) and gallium Ga68-labeled prostate specific membrane antigen PSMA-11 (68Ga-PSMA) PET/CT in influencing post-prostatectomy radiotherapy decision-making.
III. Establish the role of advanced molecular imaging with fluciclovine 18F or 68Ga-PSMA in altering radiotherapy treatment volumes.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive fluciclovine F18 intravenously (IV) and undergo a PET/CT over approximately 30 minutes.
ARM II: Patients receive 68Ga-PSMA IV, wait 60 minutes, then undergo a PET/CT over approximately 30 minutes.
After completion of study treatment, patients are followed up every 6 months for up to 5 years.
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University Hospital/Winship Cancer Institute
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Atlanta, Georgia, United States, 30342
- Emory Saint Joseph's Hospital
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Atlanta, Georgia, United States, 30303
- Grady Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adenocarcinoma of the prostate, post radical-prostatectomy
- Detectable prostate-specific antigen (PSA)
- Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2
- No definitive findings for skeletal metastasis on technetium 99-m methyl diphosphonate (MDP) or F-18 PET bone scan
- No definitive findings of systemic (extrapelvic) metastasis on CT and/or magnetic resonance (MR) scan of abdomen and pelvis
- Willingness to undergo pelvic radiotherapy
Exclusion Criteria:
- Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic radiotherapy)
- Inability to undergo fluciclovine or Ga-PSMA PET-CT
- Definitive findings of systemic metastasis on conventional imaging or biopsy
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
Severe acute co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I (fluciclovine F18, PET/CT)
Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
|
Undergo PET/CT
Other Names:
Undergo PET/CT
Other Names:
Given IV
Other Names:
|
|
Active Comparator: Arm II (68Ga-PSMA, PET/CT)
Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
|
Undergo PET/CT
Other Names:
Undergo PET/CT
Other Names:
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants Disease-Free at 2 Years
Time Frame: Up to 2 years after study start
|
A survival analysis will be conducted on disease-free survival (DFS).
The survivor functions for DFS will be estimated with Kaplan and Meier method and plotted.
The logrank test will be used to test the difference in DFS of (a) both arms in aggregate with the survivor function on our prior R01 trial and (b) between the two study arms.
|
Up to 2 years after study start
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decision to Offer Radiotherapy
Time Frame: Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks
|
Decision to offer radiotherapy or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test.
|
Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks
|
|
Decision to Treat Pelvic Nodes
Time Frame: Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks
|
Decision to provide treatment on pelvic nodes or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test.
|
Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks
|
|
Decision to Boost Between the Initial and Final Treatment Decisions
Time Frame: Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks
|
Decision to boost or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test.
|
Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks
|
|
Prostate Bed and Pelvis Clinical Target Volume (CTV) and Planning Target Volume (PTV)
Time Frame: Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks
|
Paired t-test will be used to compare the target volumes (CTV and PTV) and the planned dose delivered to surrounding bladder, rectum, and penile bulb between the initial (pre-positron emission tomography [PET]) and final (post-PET) radiation treatment plans.
|
Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks
|
|
Quality of Life: Dose Volume Histogram (DVH) of the Rectum (Percentage of Rectum Receiving 65 Gy (Rectum V65), and 40 Gy (Rectum V40))
Time Frame: Up to 4 weeks post-treatment
|
Spearman's correlation coefficient will be used to measure the correlations of the Rectum dosimetric endpoints (Rectum 65 and Rectum V40) with the grades (0, 1, 2, or 3) (as defined in Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) with acute gastrointestinal (GI) toxicity.
A Wald test will be used to test the significance level of their correlations.
|
Up to 4 weeks post-treatment
|
|
Quality of Life: Dose Volume Histogram (DVH) of the Bladder (Percentage of Bladder Receiving 65 Gy (Bladder V65), and 40 Gy (Bladder V40))
Time Frame: Up to 4 weeks post-treatment.
|
Spearman's correlation coefficient will be used to measure the correlations of the Bladder dosimetric endpoints (Bladder V65 and Bladder V40) with the grades (0, 1, 2, or 3) (as defined in Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) with acute genitourinary (GU) toxicity.
A Wald test will be used to test the significance level of their correlations.
|
Up to 4 weeks post-treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ashesh Jani, MD, MSEE, Emory University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 10, 2019
Primary Completion (Actual)
May 19, 2025
Study Completion (Estimated)
May 19, 2030
Study Registration Dates
First Submitted
November 27, 2018
First Submitted That Met QC Criteria
November 30, 2018
First Posted (Actual)
December 4, 2018
Study Record Updates
Last Update Posted (Actual)
September 2, 2026
Last Update Submitted That Met QC Criteria
August 12, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00106863
- P30CA138292 (U.S. NIH Grant/Contract)
- NCI-2018-02702 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- RAD4516-18 (Other Identifier: Emory University Hospital/Winship Cancer Institute)
- R01CA226992 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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