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

NCT05004285 | Active Not Recruiting Phase 3

• 1 other identifier: Protocol FC303-3
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

High Risk Prostate Carcinoma

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic sensitivity and specificity analyzed for patients based on histological findings

  For the sensitivity and specificity analyzed for patients of MRI diagnostic imaging and PET/CT diagnostic imaging based on histological findings, present the frequency, percentage and corresponding 95% confidence interval for each group, and conduct the McNemar's test for between-group difference. If the p-value from the McNemar's test is \<0.05 for both sensitivity and specificity, superiority of PET/CT diagnostic imaging to MRI diagnostic imaging is declared.

  MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).

Secondary Outcomes (9)

• Diagnostic sensitivity analyzed for lesions based on histological findings

  MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).

• Diagnostic specificity analyzed for lesions based on histological findings

  MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).

• Negative predictive value of diagnosis analyzed for patients based on histological findings

  MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).

• Positive predictive value of diagnosis analyzed for patients based on histological findings

  MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).

• Negative predictive value of diagnosis analyzed for lesions based on histological findings

  MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).

Study Arms (1)

MRI / [F-18]Florastamin

OTHER

MRI and \[F-18\]Florastamin PET/CT are performed for each subject.

Drug: [F-18]Florastamin

Interventions

[F-18]Florastamin DRUG

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.

MRI / [F-18]Florastamin

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: Male patients aged 20 years or older.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Subjects who were not previously diagnosed with prostate cancer at the time of screening
• Subjects who can conduct prostate histology
• Subjects with the ECOG Performance score of ≤2 at screening
• 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)
• 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

You may not qualify if:

• Subjects who were previously diagnosed with prostate cancer
• Subjects with a history of acute urinary retention, urinary tract infection or other urinary infection within 4 weeks of screening
• Subjects who conducted cystoscopy, urethral catheter procedure or colonoscopy within 4 weeks of screening
• 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
• Subjects who received 5-alpha reductase inhibitors within 3 months of screening or currently on them at screening
• Subjects with hypersensitivity to any component of the radiopharmaceutical product
• Subjects determined by the investigator to have difficulty in conducting the study due to serious medical disease
• 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
• Subjects who are planned to administer contraindicated concomitant medication (antiplatelet agents/anticoagulants, thrombolytics or circulatory improvement agents) between 5 days before biopsy and \[Visit 3 + 3D\]
• Subjects who are otherwise determined to be ineligible to take part in this study at the medical discretion of the investigator

Sponsors & Collaborators

• FutureChem: lead

Study Sites (5)

National Cancer Center

Gyeonggi-do, South Korea

Location

The Catholic University of Korea, St. Vincent's Hospital

Gyeonggi-do, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Location

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Related Links

• Prostate Specific Antigen (PSA) Test, Results, Levels \& Ranges

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ji Youl Lee, Ph.D

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: compare PET/CT Imaging Diagnosis with MRI Diagnosis for one subject

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 13, 2021
• Study Start: April 28, 2021
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)