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PET/CT Scan with Tracers for Prostate Cancer

Phase 2
Waitlist Available
Led By Ashesh Jani, MD, MSEE
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2
Adenocarcinoma of the prostate, post radical-prostatectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years after study start
Awards & highlights

Study Summary

This trial is studying whether a PET/CT scan using fluciclovine F18 or 68Ga-PSMA is better at planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma.

Who is the study for?
This trial is for men with prostate adenocarcinoma who've had surgery but still have detectable PSA levels, no signs of metastasis outside the pelvis or in bones, and can perform daily activities (ECOG 0-2). They must be willing to undergo pelvic radiotherapy and not have other recent cancers or severe illnesses like heart failure, infections needing IV antibiotics, severe lung disease, AIDS, or conditions that prevent radiation therapy.Check my eligibility
What is being tested?
The study compares two types of PET/CT scans using different tracers—Fluciclovine F18 and Ga68-labeled PSMA—to see which one is better at guiding radiation treatment plans for prostate cancer. The goal is to find out if one tracer leads to improved outcomes over the other in patients post-prostatectomy.See study design
What are the potential side effects?
As this trial involves diagnostic imaging rather than drug treatments, side effects are minimal but may include discomfort from the injection of radiotracers and exposure to a low level of radiation during the PET/CT scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to get out of my bed or chair and move around.
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I had surgery to remove my prostate due to adenocarcinoma.
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I am willing to undergo pelvic radiotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years after study start
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years after study start for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease-free survival
Secondary outcome measures
Decision to boost between the initial and final treatment decisions
Decision to offer radiotherapy
Decision to treat pelvic nodes
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (fluciclovine F18, PET/CT)Experimental Treatment3 Interventions
Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
Group II: Arm II (68Ga-PSMA, PET/CT)Active Control3 Interventions
Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluciclovine (18F)
FDA approved
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2240

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,439 Total Patients Enrolled
Telix Pharmaceuticals (Innovations) Pty LimitedIndustry Sponsor
17 Previous Clinical Trials
1,215 Total Patients Enrolled
Telix International Pty LtdIndustry Sponsor
18 Previous Clinical Trials
1,227 Total Patients Enrolled

Media Library

Fluciclovine F18 Clinical Trial Eligibility Overview. Trial Name: NCT03762759 — Phase 2
Prostate Adenocarcinoma Research Study Groups: Arm I (fluciclovine F18, PET/CT), Arm II (68Ga-PSMA, PET/CT)
Prostate Adenocarcinoma Clinical Trial 2023: Fluciclovine F18 Highlights & Side Effects. Trial Name: NCT03762759 — Phase 2
Fluciclovine F18 2023 Treatment Timeline for Medical Study. Trial Name: NCT03762759 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Fluciclovine F18 have any dangerous side effects for human patients?

"Fluciclovine F18 is a Phase 2 medication, which means that while there is some data supporting its safety, none of the available information suggests that it is an effective treatment."

Answered by AI

Can patients still sign up for this research study?

"The trial, which was first advertised on May 10th 2019 and last updated on August 8th 2020, is still recruiting patients as noted on clinicaltrials.gov"

Answered by AI

To your knowledge, is this the first time this kind of trial has been conducted?

"Fluciclovine F18 has been the subject of clinical trials since 2019 by Telix International Pty Ltd. The first study, which involved 140 patients and was conducted in 21 cities across 1 country, resulted in Phase 2 drug approval for Fluciclovine F18. Currently, there are 7 live studies being conducted on Fluciclovine F18."

Answered by AI

Are there any other papers which document Fluciclovine F18's effects?

"Currently, there are 7 clinical trials underway for Fluciclovine F18. 1 of those is in the critical Phase 3 stage. Most of the research being done on this medication is based out of Boston, Massachusetts; though, 28 different centres across the United States are running trials."

Answered by AI

How many individuals are being observed in this clinical trial?

"That is correct. The clinical trial is recruiting participants as of right now. According to the information on clinicaltrials.gov, the study was posted on 5/10/2019 and last edited on 8/8/2022. They are looking for a total of 140 patients from 3 different sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes
Ashesh B Jani 2019. "Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03762759.
~35 spots leftby Dec 2025
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