[18F]Florastamin PET/CT Imaging Examination in Patients With Suspected Recurrent or Metastatic Pr… (NCT05936658) | Clinical Trial Compass
Active — Not RecruitingPhase 3
[18F]Florastamin PET/CT Imaging Examination in Patients With Suspected Recurrent or Metastatic Prostate Cancer
South Korea138 participantsStarted 2023-05-08
Plain-language summary
This is a multi-center, open-label, single arm Phase III clinical trial for the diagnostic efficacy assessment and safety evaluation by \[18F\]Florastamin PET/CT imaging examination to determine the presence of recurrent or metastatic prostate cancer in patients whose recurrent or metastatic lesions have been confirmed through the conventional imaging.
Who can participate
Age range
19 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male aged 19 and older
. Patients histopathologically diagnosed with prostate cancer
. Patients who can undergo a percutaneous biopsy or PLND for more than one lesion locations with locally recurrent, new or advanced metastasis as confirmed by MRI or whole-body bone scan performed within 6 weeks prior to screening
. Patients whose survival is expected to be at least 6 months with ECOG Performance Status ≤ 2
. Those whose ICF was signed by themselves or their legal guardian or representative after sufficient explanation was given by the investigator about the study objectives, details, characteristics of the investigational device, etc. before enrolled for the study.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The positive predictive values(PPV) Evaluation of [18F]Florastamine PET/CT
Timeframe: [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).
. Subjects who have the following disease within 6 months prior to screening:
. Patients who are receiving radiation therapy or ablative therapy on the prostate bed within 12 weeks prior to screening
. Patients whose method of systemic treatment for prostate cancer (e.g., hormone therapy, biological therapy, radiation therapy, or chemotherapy) has changed within 3 months prior to screening, or who have to change orstart systemic treatment for prostate cancer while the study is being conducted (until before a biopsy or PLND) However, when systemic treatment has changed into watchful waiting, the patient can participate in the study.
. According to the laboratory test results, patients who meet the following criteria:
. Subjects who are suffering from active infectious disease at screening and determined unfit to participate in this study;
. Subjects with solid tumors other than prostate cancer or hematologic malignancies including lymphoma within 3 years prior to screening (however, they can be enrolled in the case of properly treated non-melanoma skin cancer)
. Subjects who received gamma-emitting radioactive isotopes of high energy (\> 300 keV) within the period 5 times longer than the half-life of this investigational product (about 10 hours) prior to screening