NCT03762759Active, not recruitingPhase 2
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 · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (actual)
- First submitted
- 27 Nov 2018
- Start date
- 10 May 2019
- Primary completion date
- 19 May 2025
- Lead sponsor
- Emory University
- Diseases
- Prostate cancer
- NCT number
- NCT03762759
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 140
- From 10 May 2019 to the primary completion date, 19 May 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic radiotherapy)
Other illness
- 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
Other
- Inability to undergo fluciclovine or Ga-PSMA PET-CT
- Definitive findings of systemic metastasis on conventional imaging or biopsy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Hospital/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Grady Health System Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Emory Saint Joseph's Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.