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High Risk Prostate CarcinomaPhase 3NCT05004285

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

A Phase 3 study testing [F-18]Florastamin in people with High Risk Prostate Carcinoma, run by FutureChem at 5 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 years and older, men only
Conditions the study is for
High Risk Prostate Carcinoma
What is being tested?
[F-18]Florastamin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
398 participants
Where
5 sitesSouth Korea
Study dates
28 Apr 2021to 1 Jun 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

South Korea5 sites

  • National Cancer Center

    Gyeonggi-do

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

    Gyeonggi-do

  • Korea University Anam Hospital

    Seoul

  • Samsung Medical Center

    Seoul

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

    Seoul

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
[F-18]Florastamin
Keywords
Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [F-18]FlorastaminDrug

    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 groups in NCT05004285
Study groupRoleWhat they receive
MRI / [F-18]FlorastaminOtherMRI and [F-18]Florastamin PET/CT are performed for each subject.
Receives: Drug: [F-18]Florastamin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (9)

  1. Diagnostic sensitivity analyzed for lesions based on histological findings

    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

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

  2. Diagnostic specificity analyzed for lesions based on histological findings

    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

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

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

    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

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

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

    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.

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

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

    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.

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

  6. Positive predictive value of diagnosis analyzed for lesions based on histological findings

    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.

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

  7. Diagnostic accuracy analyzed for patients based on histological findings

    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

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

  8. Diagnostic accuracy analyzed for lesions based on histological findings

    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

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

  9. 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

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2021
  2. Study start28 Apr 2021
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
compare PET/CT Imaging Diagnosis with MRI Diagnosis for one subject
Masking
None (open label)
Enrolment
398 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05004285
Sponsor's protocol ID
Protocol FC303-3
Status last verified
Mar 2025
First submitted
5 Aug 2021
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Catalona WJ, Partin AW, Slawin KM, Brawer MK, Flanigan RC, Patel A, Richie JP, deKernion JB, Walsh PC, Scardino PT, Lange PH, Subong EN, Parson RE, Gasior GH, Loveland KG, Southwick PC. Use of the percentage of free prostate-specific antigen to enhance differentiation of prostate cancer from benign prostatic disease: a prospective multicenter clinical trial. JAMA. 1998 May 20;279(19):1542-7. doi: 10.1001/jama.279.19.1542.

    PubMed 9605898

  • Park HK, Hong SK, Byun SS, Lee SE. T1c prostate cancer detection rate and pathologic characteristics: comparison between patients with serum prostate-specific antigen range of 3.0 to 4.0 ng/mL and 4.1 to 10.0 ng/mL in Korean population. Urology. 2006 Jul;68(1):85-8. doi: 10.1016/j.urology.2006.01.067. Epub 2006 Jun 27.

    PubMed 16806412

  • Johnson DC, Raman SS, Mirak SA, Kwan L, Bajgiran AM, Hsu W, Maehara CK, Ahuja P, Faiena I, Pooli A, Salmasi A, Sisk A, Felker ER, Lu DSK, Reiter RE. Detection of Individual Prostate Cancer Foci via Multiparametric Magnetic Resonance Imaging. Eur Urol. 2019 May;75(5):712-720. doi: 10.1016/j.eururo.2018.11.031. Epub 2018 Dec 1.

    PubMed 30509763

  • Hofman MS, Murphy DG, Williams SG, Nzenza T, Herschtal A, Lourenco RA, Bailey DL, Budd R, Hicks RJ, Francis RJ, Lawrentschuk N. A prospective randomized multicentre study of the impact of gallium-68 prostate-specific membrane antigen (PSMA) PET/CT imaging for staging high-risk prostate cancer prior to curative-intent surgery or radiotherapy (proPSMA study): clinical trial protocol. BJU Int. 2018 Nov;122(5):783-793. doi: 10.1111/bju.14374. Epub 2018 Jun 3.

    PubMed 29726071

  • Chang SS. Overview of prostate-specific membrane antigen. Rev Urol. 2004;6 Suppl 10(Suppl 10):S13-8.

    PubMed 16985927

  • Szabo Z, Mena E, Rowe SP, Plyku D, Nidal R, Eisenberger MA, Antonarakis ES, Fan H, Dannals RF, Chen Y, Mease RC, Vranesic M, Bhatnagar A, Sgouros G, Cho SY, Pomper MG. Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. Mol Imaging Biol. 2015 Aug;17(4):565-74. doi: 10.1007/s11307-015-0850-8.

    PubMed 25896814

  • Maurer T, Eiber M, Schwaiger M, Gschwend JE. Current use of PSMA-PET in prostate cancer management. Nat Rev Urol. 2016 Apr;13(4):226-35. doi: 10.1038/nrurol.2016.26. Epub 2016 Feb 23.

    PubMed 26902337

  • Rhee H, Thomas P, Shepherd B, Gustafson S, Vela I, Russell PJ, Nelson C, Chung E, Wood G, Malone G, Wood S, Heathcote P. Prostate Specific Membrane Antigen Positron Emission Tomography May Improve the Diagnostic Accuracy of Multiparametric Magnetic Resonance Imaging in Localized Prostate Cancer. J Urol. 2016 Oct;196(4):1261-7. doi: 10.1016/j.juro.2016.02.3000. Epub 2016 May 21.

    PubMed 27220897

  • Lee I, Lim I, Byun BH, Kim BI, Choi CW, Woo SK, Lee KC, Kang JH, Kil HS, Park C, Chi DY, Park J, Song K, Lim SM. A microdose clinical trial to evaluate [18F]Florastamin as a positron emission tomography imaging agent in patients with prostate cancer. Eur J Nucl Med Mol Imaging. 2021 Jan;48(1):95-102. doi: 10.1007/s00259-020-04883-y. Epub 2020 May 26.

    PubMed 32458006

  • Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.

    PubMed 7165009

  • Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.

    PubMed 28110982

  • Valerio M, Anele C, Charman SC, van der Meulen J, Freeman A, Jameson C, Singh PB, Emberton M, Ahmed HU. Transperineal template prostate-mapping biopsies: an evaluation of different protocols in the detection of clinically significant prostate cancer. BJU Int. 2016 Sep;118(3):384-90. doi: 10.1111/bju.13306. Epub 2015 Sep 25.

    PubMed 26332050

  • Weinreb JC, Barentsz JO, Choyke PL, Cornud F, Haider MA, Macura KJ, Margolis D, Schnall MD, Shtern F, Tempany CM, Thoeny HC, Verma S. PI-RADS Prostate Imaging - Reporting and Data System: 2015, Version 2. Eur Urol. 2016 Jan;69(1):16-40. doi: 10.1016/j.eururo.2015.08.052. Epub 2015 Oct 1.

    PubMed 26427566

  • Leisenring W, Alonzo T, Pepe MS. Comparisons of predictive values of binary medical diagnostic tests for paired designs. Biometrics. 2000 Jun;56(2):345-51. doi: 10.1111/j.0006-341x.2000.00345.x.

    PubMed 10877288

  • Wang W, Davis CS, Soong SJ. Comparison of predictive values of two diagnostic tests from the same sample of subjects using weighted least squares. Stat Med. 2006 Jul 15;25(13):2215-29. doi: 10.1002/sim.2332.

    PubMed 16220470

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing [F-18]Florastamin in people with High Risk Prostate Carcinoma, run by FutureChem at 5 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05004285, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.

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