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

October 26, 2023 updated by: FutureChem

A Multi Center, Non-randomized, Open, Phase 3 Study to Evaluate the Clinical Usefulness of [F-18]Florastamin PET/CT Imaging Diagnosis Compared to MRI Diagnosis in Prostate Cancer Risk Groups

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Once a subject provides voluntary written consent on participation in this study, the investigator conducts screening of the subject. Subsequently, MRI and [F-18]Florastamin PET/CT are performed for each patient, only for those who satisfy the inclusion/exclusion criteria. For MRI at Visit 2, routine MRI, as implemented in the Urology Department, is performed in the abdomen and pelvis. On the date of or within 7 days after MRI, a single dose of [F-18]Florastamin at 10 ± 1 mCi is IV administered to a subject, and PET/CT images are obtained from the head to thigh after 110 ± 10 minutes (care should be taken to prevent extravasation of the radiopharmaceutical product). At Visit 3, the principal investigator or a treating doctor as delegated by the principal investigator conducts the template prostate-mapping (TPM) biopsy in at least the Modified Barzell 20-zone using the standard template. After general anesthesia or spinal anesthesia, the tissue is collected by horizontally sticking a histological needle through the perineum, and the process can be performed as in-patient, at the discretion of the investigator.

The MRI finding is determined positive for a lesion with the PI-RADS score of 3 or higher, and the [F-18]Florastamin PET/CT finding is considered positive for the focal uptake higher than the background level and unrelated with the physiologic uptake or known pitfall.

MRI and [F-18]Florastamin PET/CT images are sent to the central reading institution, Seoul St. Mary's Hospital, after blinding for the study information. Suspected sites on MRI are evaluated at the Seoul St. Mary's Hospital Radiology Department, and the suspected sites on [F-18]Florastamin PET/CT are assessed at the Seoul St. Mary's Hospital Nuclear Medicine Department. Note that the [F-18]Florastamin PET/CT rater would participate in the assessment after undergoing sufficient training with [F-18]Florastamin PET/CT images from a Phase 1 study of the same product.

A pathologist at each center will conduct diagnosis of prostate cancer for TPM biopsy samples from the entire prostate volume. Target biopsy of MRI and [F-18]Florastamin PET/CT will not be performed. By comparing confirmed sites from each imaging diagnosis method and positive/negative results for prostate cancer from TPM biopsy diagnosis, the proportions of True Positive (TP), False Positive (FP), True Negative (TN), False Negative (FN) will be analyzed and the sensitivity, specificity, negative predictive value, positive predictive value, and diagnostic accuracy will be compared using a 2x2 contingency table.

Study Type

Interventional

Enrollment (Estimated)

398

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of
        • Recruiting
        • National Cancer Center
        • Contact:
      • Gyeonggi-do, Korea, Republic of
        • Recruiting
        • The Catholic university of Korea, St. Vincent's Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • The Catholic University of Korea, Seoul St. Mary's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MRI / [F-18]Florastamin
MRI and [F-18]Florastamin PET/CT are performed for each subject.
Drug: [F-18]Florastamin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic sensitivity and specificity analyzed for patients based on histological findings
Time Frame: MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic sensitivity analyzed for lesions based on histological findings
Time Frame: MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).
For the following endpoints, present the frequency, percentage and corresponding 95% confidence interval for each group, and conduct the McNemar's test for between-group difference
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
Time Frame: MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).
For the following endpoints, present the frequency, percentage and corresponding 95% confidence interval for each group, and conduct the McNemar's test for between-group difference
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
Time Frame: MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).
For the following endpoints, present the frequency, percentage and corresponding 95% confidence interval for each group, and test for the between-group difference with generalized score statistics
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
Time Frame: MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).
For the following endpoints, present the frequency, percentage and corresponding 95% confidence interval for each group, and test for the between-group difference with generalized score statistics.
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
Time Frame: MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).
For the following endpoints, present the frequency, percentage and corresponding 95% confidence interval for each group, and test for the between-group difference with generalized score statistics.
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 lesions based on histological findings
Time Frame: MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).
For the following endpoints, present the frequency, percentage and corresponding 95% confidence interval for each group, and test for the between-group difference with generalized score statistics.
MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).
Diagnostic accuracy analyzed for patients based on histological findings
Time Frame: MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).
For the following endpoints, present the frequency, percentage and corresponding 95% confidence interval for each group, and conduct the McNemar's test for between-group difference
MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).
Diagnostic accuracy analyzed for lesions based on histological findings
Time Frame: MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).
For the following endpoints, present the frequency, percentage and corresponding 95% confidence interval for each group, and conduct the McNemar's test for between-group difference
MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).
Proportion of subjects who can be excluded from histology among those who are determined to be positive from MRI (PI-RADS ≥3) diagnosis but negative from [F-18]Florastamin PET/CT diagnosis based on histological findings
Time Frame: MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).
Present the proportion and corresponding 95% confidence interval of subjects who can be excluded from histology among those who are determined to be positive from MRI (PI-RADS ≥3) diagnosis but negative from [F-18]Florastamin PET/CT diagnosis based on histological findings
MRI and PET/CT conduct at V2(0 day), TPM Biopsy conduct at V3(V2+1~14 day).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FutureChem

Investigators

  • Principal Investigator: Ji Youl Lee, Ph.D, The Catholic University of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2021

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

August 5, 2021

First Submitted That Met QC Criteria

August 5, 2021

First Posted (Actual)

August 13, 2021

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol FC303-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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