[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 range19 Years
SexMALE
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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
✕. 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:
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 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
✕. Subjects with hypersensitivity to radioisotopes