Clinical trial · Interventional
Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes
Advanced PET-CT Directed Post-Prostatectomy Radiotherapy to Enhance Prostate Cancer Outcomes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Fluciclovine F18 | Drug | — | UNRESOLVED |
| Gallium Ga68-labeled PSMA-11 | Radiation | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (fluciclovine F18, PET/CT)
- description
- Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
- interventionNames
- Procedure: Computed Tomography
- Drug: Fluciclovine F18
- Procedure: Positron Emission Tomography
- type
- ACTIVE_COMPARATOR
- label
- Arm II (68Ga-PSMA, PET/CT)
- description
- Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
- interventionNames
- Procedure: Computed Tomography
- Radiation: Gallium Ga68-labeled PSMA-11
- Procedure: Positron Emission Tomography
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAbiodun-Ojo OA, Jani AB, Goyal S, Lawal IO, Halkar RK, Dhere V, Shelton JW, Patel PR, Schreibmann E, Hershatter B, Patel SA, Hanasoge S, Sebastian NT, Schuster DM. 18F-Fluciclovine or 68Ga-PSMA-11 PET/CT-guided Salvage Radiotherapy Changes in Postprostatectomy Biochemical Recurrence: Secondary Analysis of the EMPIRE-2 Trial. Radiology. 2026 Jun;319(3):e251874. doi: 10.1148/radiol.251874. PMID 42377125