Impact of Fluciclovine (18F) PET (Positron Emission Tomography) on the Management of Prostate Cancer Following Negative or Equivocal PSMA (Prostate-Specific Membrane Antigen) PET Imaging at the Time of Biochemical Recurrence
The Impact of Fluciclovine (18F) PET on the Management of Participants With Prostate Cancer Following Negative or Equivocal PSMA PET Imaging at the Time of Biochemical Recurrence
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at whether a fluciclovine (18F) PET scan changes care for men whose prostate cancer may have come back after treatment. It is for men whose PSA blood tests suggest the cancer has returned, but whose PSMA PET scan found no cancer or gave unclear results. Both scans use radioactive tracers to help find cancer.
The impact of fluciclovine (18F) PET on the management of participants with prostate cancer following negative or equivocal PSMA PET Imaging at the time of biochemical recurrence
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be a man age 18 or older.
- Have signs that prostate cancer may have returned after treatment meant to cure it. Have a negative or unclear PSMA PET scan using an FDA-approved tracer within 45 days before the study scan.
- After surgery to remove the prostate: have a PSA level of at least 0.2 ng/mL, measured more than 6 weeks after surgery. PSA is a blood marker used to track prostate cancer.
- After radiation treatment: have PSA at least 2.0 ng/mL above its lowest level, with repeat tests showing it is rising.
- If sexually active with a woman who could become pregnant, agree to use highly effective birth control for 24 hours after the study tracer injection.
- Sign a consent form before any study procedures.
- Be able to follow the study procedures.
Who can't join
- Have prostate cancer that has spread and keeps growing despite treatment to lower testosterone.
- Have a health problem or other situation, including use of an experimental treatment, that the study doctor thinks could affect the results or your ability to follow study rules.
- Plan to receive X-ray contrast dye or another PET tracer too close to the study scan. The timing limit is based on how long the radioactive tracer takes to break down.
- Have joined a trial that tests a treatment within 30 days and received an experimental treatment within the stated time limit before the study scan.
- Have a known allergy to fluciclovine (18F) or any of its ingredients.
- Have already received treatment for the current suspected return of prostate cancer.
- Start cancer treatment, radiation, or supplements or herbs meant to treat cancer between the PSMA PET scan and the study scan.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Participants must be males aged ≥18 years at Screening. 2. Participants with suspected BCR of prostate cancer (see Inclusion Criterion #3 below) following prior curative intent treatment and a negative or equivocal PSMA PET scan with any FDA-approved PSMA PET tracer (must be within 45 days prior to Visit 2 \[fluciclovine (18F) PET/CT scan\]), regardless of findings on conventional imaging. 3. Participants suspicious for a biochemically recurrent prostate cancer with a detectable or rising PSA after definitive therapy on the basis of: Post-radical prostatectomy (with or without adjuvant or salvage radiation therapy): PSA that is ≥0.2 ng/mL (completed \>6 weeks after surgery) or Post-radiation therapy (with or without ADT): Increase in PSA level that is ≥2.0 ng/mL above the nadir PSA level and rising PSA is confirmed on consecutive PSA determinations. 4. Men who are sexually active with women of childbearing potential (WOCBP), must agree to use a highly effective method(s) of contraception for 24 hours post-fluciclovine (18F) injection. 5. Participants must provide written informed consent before any study-specific procedures or interventions are performed. 6. Ability of the participants to comply with planned study procedures Exclusion Criteria: 1. Participants with known metastatic castrate resistant prostate cancer. 2. Participants with any medical condition (including intercurrent illness and uncontrolled serious infection) or circumstance (including receiving an IP) that the investigator believes may compromise the data collected or lead to a failure to comply with the study requirements. 3. Participants who are planned to have an x-ray contrast agent or any other PET radiotracer within five physical half-lives of the first PET radionuclide prior to the study fluciclovine (18F) PET/CT scan. 4. Participants participating in an interventional clinical trial within 30 days and having received an IP five physical half-lives prior to the study fluciclovine (18F) PET/CT scan. 5. Participants with known hypersensitivity to the active substance or to any of the excipients of fluciclovine (18F). 6. Participants who have received salvage therapy for the current episode of BCR. 7. Participants who initiate cancer treatment (systemic or radiation therapy) or who have started any supplements or herbal medications intended to treat cancer between the PSMA PET and fluciclovine (18F) PET/CT scans.
Study sites (6)
CA
- University of California San Diego Health · San Diego, CA 92103Sherief H Gamie, MD · Study contactMore trials in San Diego
GA
- Emory University · Atlanta, GA 30322Ismaheel Lawal, MD · Study contactMore trials in Atlanta
MA
- Massachusetts General Hospital · Boston, MA 02114Pedram Heidari, MD · Study contactMore trials in Boston
MO
- Washington University · St Louis, MO 63110Ashwin Parihar, MD · Study contactMore trials in St Louis
OR
- Oregon Health & Science University · Portland, OR 97239Nadine Mallak, MD · Study contactMore trials in Portland
TX
- Urology Austin · Austin, TX 78759Brian Mazzarella, MD · Study contactMore trials in Austin