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Fluciclovine PET for Prostate Cancer Recurrence
Phase 4
Recruiting
Led By Nadine Mallak, M.D.
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment up to 1 month after scan
Awards & highlights
Study Summary
This trial will test if Fluciclovine PET can detect prostate cancer recurrence when PSMA PET can't and if it changes patient treatment.
Who is the study for?
This trial is for adults over 18 with prostate cancer that has come back, as shown by rising PSA levels, but who have a negative or unclear PSMA PET scan. They must understand and agree to the study's procedures after initial treatments like surgery or radiation.Check my eligibility
What is being tested?
The study is looking at how well Fluciclovine PET scans can find where prostate cancer has returned in patients whose PSMA PET scans didn't show anything. It will also see if these Fluciclovine PET results lead to changes in patient care.See study design
What are the potential side effects?
Fluciclovine PET/CT involves exposure to a small amount of radiation, which carries a risk of causing future cancers. The injection might cause pain or irritation at the site. Allergic reactions are rare but possible.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment up to 1 month after scan
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment up to 1 month after scan
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with BCR and a positive Fluciclovine PET performed within 30 days after a negative or equivocal PSMA PET
Secondary outcome measures
Change in management based on the results of Fluciclovine PET, relative to intended management based on the result of negative PSMA PET alone, prior to obtaining the Fluciclovine PET.
Correct localization rate (CLR) of Fluciclovine PET in patients with positive scans.
Number of participants with positive Fluciclovine PET summarized by site of recurrence (local recurrence in the prostate bed, lymph node involvement, or distant metastatic disease), stratified by PSA level
Trial Design
1Treatment groups
Experimental Treatment
Group I: Fluciclovine PET/CTExperimental Treatment1 Intervention
Participants will undergo Fluciclovine PET/CT within 30 days of a negative or equivocal PSMA PET scan. After the Fluciclovine PET/CT, the patient will follow up with their treating physician as per standard-of-care. The research team will collect clinical and imaging data at 6 months post Fluciclovine-PET/CT.
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Who is running the clinical trial?
Blue Earth DiagnosticsIndustry Sponsor
38 Previous Clinical Trials
2,937 Total Patients Enrolled
10 Trials studying Prostate Cancer
1,277 Patients Enrolled for Prostate Cancer
OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,676 Total Patients Enrolled
26 Trials studying Prostate Cancer
2,383 Patients Enrolled for Prostate Cancer
Blue Earth Diagnostics, IncUNKNOWN
4 Previous Clinical Trials
120 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I do not have any serious infections that are uncontrolled.I haven't started any new cancer treatments or supplements between my PSMA and Axumin scans.I had prostate cancer treatment, but scans don't clearly show if it's back.
Research Study Groups:
This trial has the following groups:- Group 1: Fluciclovine PET/CT
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food and Drug Administration endorsed Fluciclovine PET/CT?
"Because it has been approved, Fluciclovine PET/CT was given a score of 3 on the safety scale."
Answered by AI
Are there any available openings in this medical experiment?
"The clinical trial hosted on clinicaltrials.gov is not presently looking for participants; the listing was first created on March 1st 2023 and last edited February 1st, 2023. Despite this, there are currently 2257 other studies open to new patients."
Answered by AI
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