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Prostate AdenocarcinomaPhase 2NCT03762759

Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes

A Phase 2 study testing Computed Tomography, Fluciclovine F18 and Gallium Ga68-labeled PSMA-11 in people with Prostate Adenocarcinoma, run by Emory University at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Adenocarcinoma
What is being tested?
Computed Tomography, Fluciclovine F18 and Gallium Ga68-labeled PSMA-11
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
3 sitesUnited States
Study dates
10 May 2019to 19 May 2030
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Grady Health System

    Atlanta, Georgia, 30303

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES

  1. 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.

Being tested
Computed Tomography, Fluciclovine F18, Gallium Ga68-labeled PSMA-11, Positron Emission Tomography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed TomographyProcedure or surgery

    Also called CT, CT scan, Computerized axial tomography, CAT

    Undergo PET/CT

  • Fluciclovine F18Drug

    Also called anti-3-[18F]FACBC, Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid, FACBC, [18F]FACBC

    Given IV

  • Gallium Ga68-labeled PSMA-11Radiation

    Also called 68Ga-PSMA, 68Ga PSMA, [68Ga] Prostate-specific Membrane Antigen 11, 68Ga-DKFZ-PSMA-11

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called PET, PET scan, Proton magnetic resonance spectroscopic imaging

    Undergo PET/CT

Study groups in NCT03762759
Study groupRoleWhat they receive
Arm I (fluciclovine F18, PET/CT)ExperimentalPatients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
Receives: Procedure: Computed Tomography; Drug: Fluciclovine F18; Procedure: Positron Emission Tomography
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.
Receives: Procedure: Computed Tomography; Radiation: Gallium Ga68-labeled PSMA-11; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Disease-Free at 2 Years

    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.

    Measured: Up to 2 years after study start

Secondary outcomes (6)

  1. Decision to Offer Radiotherapy

    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.

    Measured: Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks

  2. Decision to Treat Pelvic Nodes

    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.

    Measured: Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks

  3. Decision to Boost Between the Initial and Final Treatment Decisions

    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.

    Measured: Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks

  4. Prostate Bed and Pelvis Clinical Target Volume (CTV) and Planning Target Volume (PTV)

    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.

    Measured: Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks

  5. Quality of Life: Dose Volume Histogram (DVH) of the Rectum (Percentage of Rectum Receiving 65 Gy (Rectum V65), and 40 Gy (Rectum V40))

    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.

    Measured: Up to 4 weeks post-treatment

  6. Quality of Life: Dose Volume Histogram (DVH) of the Bladder (Percentage of Bladder Receiving 65 Gy (Bladder V65), and 40 Gy (Bladder V40))

    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.

    Measured: Up to 4 weeks post-treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2018
  2. Study start10 May 2019
  3. Primary completion19 May 2025
  4. Study completion19 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03762759
Sponsor's protocol ID
IRB00106863
Other IDs
NCI-2018-02702, RAD4516-18, R01CA226992, P30CA138292
Status last verified
Aug 2026
First submitted
27 Nov 2018
Last updated
2 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Abiodun-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.

    PubMed 42377125

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Computed Tomography, Fluciclovine F18 and Gallium Ga68-labeled PSMA-11 in people with Prostate Adenocarcinoma, run by Emory University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Disease-Free at 2 Years (time frame: Up to 2 years after study start). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03762759, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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