Fluciclovine F18 for Prostate Adenocarcinoma

Emory University Hospital/Winship Cancer Institute, Atlanta, GA
Prostate AdenocarcinomaFluciclovine F18 - Drug
Eligibility
18+
Male
What conditions do you have?
Select

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.

Eligible Conditions
  • Prostate Adenocarcinoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Diagnostic (fluciclovine F18 PET/CT)
1
Catheterization
1
Low Dose

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 2 years after study start

Year 2
Disease-free survival
Year 5
Decision to boost between the initial and final treatment decisions
Decision to offer radiotherapy
Decision to treat pelvic nodes
PTV of the bladder (V65, V40)
PTV of the rectum (V65, V40)
Prostate bed clinical target volume (CTV) and planning target volume (PTV)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Diagnostic (fluciclovine F18 PET/CT)
1
Catheterization
1
Low Dose

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Arm II (68Ga-PSMA, PET/CT)
1 of 2
Arm I (fluciclovine F18, PET/CT)
1 of 2

Active Control

Experimental Treatment

140 Total Participants · 2 Treatment Groups

Primary Treatment: Fluciclovine F18 · No Placebo Group · Phase 2

Arm I (fluciclovine F18, PET/CT)Experimental Group · 3 Interventions: Fluciclovine F18, Computed Tomography, Positron Emission Tomography · Intervention Types: Drug, Procedure, Procedure
Arm II (68Ga-PSMA, PET/CT)ActiveComparator Group · 3 Interventions: Computed Tomography, Positron Emission Tomography, Gallium Ga68-labeled PSMA-11 · Intervention Types: Procedure, Procedure, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluciclovine (18F)
FDA approved
Computed Tomography
2017
Completed Phase 2
~2710
Positron Emission Tomography
2008
Completed Phase 2
~2290

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years after study start

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,550 Previous Clinical Trials
24,611,005 Total Patients Enrolled
Telix International Pty LtdIndustry Sponsor
16 Previous Clinical Trials
1,228 Total Patients Enrolled
Emory UniversityLead Sponsor
1,558 Previous Clinical Trials
2,765,601 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,272 Previous Clinical Trials
41,230,588 Total Patients Enrolled
Ashesh Jani, MD, MSEEPrincipal InvestigatorEmory University

Eligibility Criteria

Age 18+ · Male Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing to receive radiation therapy to the pelvic area.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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