Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT06862856
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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT06862856
Study Brief:
Protocol Section:
NCT06862856