Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes
Advanced PET-CT Directed Post-Prostatectomy Radiotherapy to Enhance Prostate Cancer Outcomes
5 other identifiers
interventional
140
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2019
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2018
CompletedFirst Posted
Study publicly available on registry
December 4, 2018
CompletedStudy Start
First participant enrolled
May 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMay 17, 2024
May 1, 2024
6.1 years
November 27, 2018
May 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-free survival
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 Outcomes (6)
Decision to offer radiotherapy
Up to 5 years after study start
Decision to treat pelvic nodes
Up to 5 years after study start
Decision to boost between the initial and final treatment decisions
Up to 5 years after study start
Prostate bed clinical target volume (CTV) and planning target volume (PTV)
Up to 5 years after study start
PTV of the rectum (V65, V40)
Up to 5 years after study start
- +1 more secondary outcomes
Study Arms (2)
Arm I (fluciclovine F18, PET/CT)
EXPERIMENTALPatients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
Arm II (68Ga-PSMA, PET/CT)
ACTIVE COMPARATORPatients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
Interventions
Undergo PET/CT
Given IV
Given IV
Undergo PET/CT
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Telix Pharmaceuticals (Innovations) Pty Limitedcollaborator
- National Cancer Institute (NCI)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (3)
Grady Health System
Atlanta, Georgia, 30303, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashesh Jani, MD, MSEE
Emory University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 27, 2018
First Posted
December 4, 2018
Study Start
May 10, 2019
Primary Completion
May 31, 2025
Study Completion
December 31, 2025
Last Updated
May 17, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share