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18F-fluciclovine PET Scan for Prostate Cancer

Phase 2
Waitlist Available
Led By Pedro C. Barata, MD, MSc
Research Sponsored by Tulane University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The use of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting is allowed;
Life expectancy of ≥ 6 months;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial is for men with metastatic prostate cancer who are resistant to hormone therapy. The men will be given either abiraterone, enzalutamide, or docetaxel to see if it prolongs their life.

Eligible Conditions
  • Metastatic Castration Resistant Prostate Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
The medication docetaxel is allowed for people with metastatic hormone-sensitive prostate cancer.
Select...
You are expected to live for at least 6 more months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in 18F-fluciclovine PET scan for patients with mCRPC on treatment with Life Prolonging Therapies
PET scan vs. conventional CT and bone scan
Other outcome measures
Compare the PET scan results with the genomic alterations in circulating tumor deoxyribonucleic acid (ctDNA)

Trial Design

1Treatment groups
Experimental Treatment
Group I: 18F-fluciclovine PET ScanExperimental Treatment1 Intervention
Single intravenous administration of 18F-fluciclovine for PET Scan.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluciclovine (18F)
FDA approved

Find a Location

Who is running the clinical trial?

Blue Earth DiagnosticsIndustry Sponsor
38 Previous Clinical Trials
3,007 Total Patients Enrolled
11 Trials studying Prostate Cancer
1,337 Patients Enrolled for Prostate Cancer
Tulane UniversityLead Sponsor
115 Previous Clinical Trials
226,492 Total Patients Enrolled
1 Trials studying Prostate Cancer
161 Patients Enrolled for Prostate Cancer
Pedro C. Barata, MD, MScPrincipal InvestigatorTulane University School of Medicine

Frequently Asked Questions

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

How many people are being asked to participate in this trial?

"That is correct, the online information hosted on clinicaltrials.gov affirms that this study is still recruiting patients. This particular trial was first posted on January 30th 2020 and updated as recently as October 21st 2022. The research team hopes to enroll 12 total patients at a single site."

Answered by AI

Is this an original research project?

"There are 7 active clinical trials ongoing for 18F-fluciclovine PET Scans in 21 cities across 1 country. The first study was conducted in 2019 and involved 140 patients. The sponsor of the trial, Telix International Pty Ltd, completed Phase 2 drug approval in 2019. Since then, 5 more studies have been conducted."

Answered by AI

Are we still recruiting people for this experiment?

"Yes, the trial is still ongoing and recruiting patients. According to the clinicaltrials.gov listing, the study was posted on 1/30/2020 and was updated as recently as 10/21/2022. They are currently searching for 12 more participants at a single site."

Answered by AI

Does this 18F-fluciclovine PET scan have any precedent?

"There are currently 7 ongoing clinical trials involving 18F-fluciclovine PET Scans, with 1 study in Phase 3. 28 medical centres across the United States are running these trials, many of which are situated in Boston, Massachusetts."

Answered by AI

Are there any ineligibility requirements for this research?

"Up to 12 individuals who have undergone castration and are between 18-18 years old may be enrolled in this study. There are several key eligibility requirements including: no prior exposure to life-prolonging therapies for mCRPC (with the exception of Sipuleucel-T), a life expectancy of greater than 6 months, an ECOG Performance status of 0-2, and being at least 18 years old."

Answered by AI

Does the FDA approve of 18F-fluciclovine PET Scanning?

"While Phase 2 trials don't have data supporting efficacy, there is some evidence that 18F-fluciclovine PET Scans are safe. This gave it a score of 2."

Answered by AI

Does this research project involve testing on elderly individuals?

"The age requirement to participate in this trial is 18-18 years old. Out of the 75 clinical trials available for patients under 18, this one is most closely matched to your needs. There are 1299 trials conducted for patients over 65."

Answered by AI
~2 spots leftby Mar 2025