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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
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

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emory University Hospital/Winship Cancer Institute
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Grady Health System
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Emory Saint Joseph's Hospital
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.