Flotufolastat F 18 PET in Men with Very Low PSA Recurrence

Launched by MASSACHUSETTS GENERAL HOSPITAL · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging test called flotufolastat F 18 PET to see how well it detects prostate cancer in men who have very low levels of a substance called prostate-specific antigen (PSA) after surgery to remove their prostate. The goal is to find out if this test can help identify any remaining cancer when PSA levels are still quite low, which is important for managing patients’ health after surgery.

To participate in this trial, men aged 18 and older must have a confirmed diagnosis of prostate cancer and have undergone surgery to remove their prostate. They should have a measurable PSA level that is concerning but still low, and enough time must have passed since their surgery. Participants will undergo the PET scan, which is a type of imaging test that helps doctors see how the cancer may be behaving in the body. It's important to note that certain medications and treatments could affect eligibility, so potential participants will need to discuss their complete medical history with the research team. Overall, this study aims to improve the way doctors monitor prostate cancer recurrence and tailor treatment to each individual patient.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Participants must have a history of localized histologically confirmed adenocarcinoma of the prostate and have received radical prostatectomy (RP) with curative intent.
• • Participants must have measurable disease, defined as a non-zero PSA value post-RP that is concerning for biochemically recurrent or persistent disease, is ≤0.20 ng/mL, and obtained within 60 days of PET/CT.
• • At least 6 weeks must have elapsed after RP. If previously taking ADT, it should have been discontinued at least 16 weeks prior to PET.
• • Participants with a clinical flotufolastat F 18 PSMA PET/CT scan prescribed as part of the standard of care management.
• • Age ≥18 years.
• • Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• • Ability to understand and the willingness to sign a written informed consent document.
• Exclusion Criteria:
• • Participants currently receiving ADT (defined as surgical orchidectomy; luteinizing hormone-releasing hormone \[LHRH\] agonist alone \[continuous or intermittent\]; LHRH antagonist alone \[continuous or intermittent\]; administration or use of a first or second generation anti-androgen alone or in combination with an LHRH agonist/antagonist).
• • Participants who are receiving any other investigational agents for this condition within five biological half-lives prior to administration of flotufolastat F 18.
• • History of allergic reactions attributed to compounds of similar chemical or biologic composition to flotufolastat F 18 or other agents used in study.
• • Participants receiving any of the following substances will be considered ineligible: x-ray contrast agent \<24 hours prior to the flotufolastat F 18 PET and any other PET imaging agent within 24 hours or 10 half-lives, whichever is longer, prior to the flotufolastat F 18 PET/CT. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.