Evaluate the Clinical Usefulness of [F-18]Florastamin PET/CT Imaging Diagnosis Compared to MRI Diagnosis

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: Male

Summary

Only in subjects who satisfy the inclusion/exclusion criteria, a single dose of [F-18]Florastamin at 10 ± 1 mCi is IV administered at Visit 2, and [F-18]Florastamin PET/CT images are obtained from the head to thigh after 110 ± 10 minutes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FutureChem

Criteria

Inclusion Criteria:

1. Adult men aged at least 20 years determined to be at the high risk of prostate cancer based on screening diagnosis performed at the Urology Department (Patients who require prostate histology due to abnormal digital rectal examination (DRE) or abnormal PSA levels, etc., and have a palpable node during DRE or satisfy PSA>3.0 ng/mL)

2. Subjects who were not previously diagnosed with prostate cancer at the time of screening

3. Subjects who can conduct prostate histology

4. Subjects with the ECOG Performance score of ≤2 at screening

5. Subjects who satisfy the following conditions for hematology, kidney function test and liver function test

① Platelets > 50,000/mm3

② BUN and serum creatinine < 1.5 x upper limit of normal (ULN)

③ AST and ALT < 2.5 x upper limit of normal (ULN)

④ PT (INR) or aPTT < 1.5 x upper limit of normal (ULN)

6. Subjects who were fully informed by the investigator about the objectives, details of the study and characteristics of the study drug, etc. during the screening visit and provide voluntary written consent to take part in this study

Exclusion Criteria:

1. Subjects who were previously diagnosed with prostate cancer

2. Subjects with a history of acute urinary retention, urinary tract infection or other urinary infection within 4 weeks of screening

3. Subjects who conducted cystoscopy, urethral catheter procedure or colonoscopy within 4 weeks of screening

4. Subjects who conducted prostate histology or prostate surgery (other than treatment for prostate hyperplasia or bladder outlet obstruction) or androgen deprivation therapy (ADT) within 1 year of screening

5. Subjects who received 5-alpha reductase inhibitors within 3 months of screening or currently on them at screening

6. Subjects with hypersensitivity to any component of the radiopharmaceutical product

7. Subjects determined by the investigator to have difficulty in conducting the study due to serious medical disease

8. Subjects determined by the investigator to have difficulty in lying still for 30-60 minutes in a supine position for radiography (CT, MRI, etc.) (example: panic disorder) or have psychiatric disorder causing difficulty in imaging

9. Subjects who are planned to administer contraindicated concomitant medication (antiplatelet agents/anticoagulants, thrombolytics or circulatory improvement agents) between 5 days before biopsy and [Visit 3 + 3D]

10. Subjects who are otherwise determined to be ineligible to take part in this study at the medical discretion of the investigator