High Risk Prostate CarcinomaPhase 3NCT05936658

[18F]Florastamin PET/CT Imaging Examination in Patients With Suspected Recurrent or Metastatic Prostate Cancer

A Phase 3 study testing [F-18]Florastamin in people with High Risk Prostate Carcinoma, run by FutureChem at 6 sites in South Korea.

Active, not recruiting

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

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 19 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: 138 participants
Where: 6 sitesSouth Korea
Study dates: 8 May 2023to 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 19 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Subjects who have the following disease within 6 months prior to screening:
Heart failure that falls into Class III or IV heart failure classified by New York Heart Association;
Embolism pulmonary, acute coronary syndrome (unstable angina or myocardial infarction);
Acute severe respiratory syndrome;
Cerebrovascular disease such as stroke;
Uncontrollable hypertension (SBP > 160 mmHg or DBP > 90 mmHg);

Show all 20Show fewer

Uncontrollable heart arrhythmia;
Blood clotting disorder.
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:
Platelet counts (PLT) < 50,000/μL;
Serum creatinine > 1.8 mg/dL or eGFR (or GFR) < 30 mL/min/1.7 m2;
AST and ALT > 2.5 x upper limit of normal (ULN) (however, for a patient whose hepatic metastasis has been confirmed, AST and ALT > 5 x ULN).
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
Subjects who participate in other clinical studies that may affect image obtainment from [18F]Florastamin-PET/CT or safety evaluation following IV injection of [18F]Florastamin from the time of enrollment for this study until the end (however, they can be enrolled if participating in a cohort clinical study conducted mainly through simple follow-up without administration of IP from the time of enrollment for the study until the end)
Subjects who cannot undergo necessary imaging examinations due to medical conditions or other conditions (serious claustrophobia, radiophobia, etc.) that undermine the subject safety or compliance status for generating reliable data or completing the study in the principal investigator's judgment

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

South Korea6 sites

National Cancer Center
Gyeonggi-do
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
Severance Hospital
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Ewha womans university mokdong medical center
Soeul

Other trials in South Korea

About this study

Official title: 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 in Patients With Suspected Recurrent or Metastatic Prostate Cancer

Read the detailed description

In this study, the diagnostic efficacy of [18F]Florastamin PET/CT imaging at detecting recurrent or metastatic prostate cancer will be evaluated according to the histopathology truth standard in prostate cancer patients whose recurrent or metastatic lesions have been confirmed with the conventional imaging.

Patients who meet the inclusion/exclusion criteria of the clinical study protocol will be enrolled, who then will undergo a biopsy or pelvic lymph node dissection (PLND) for one or more lesion locations confirmed with the conventional imaging within 28 days from [18F]Florastamin PET/CT scanning. After the biopsy or PLND, follow-up will be carried out for 2 weeks. However, if necessary, based on the judgment of the principal investigator, additional visits may be made.

Baseline Procedures At the baseline visit, the conventional imaging will be performed. The results of whole-body bone scan and gadolinium-enhanced MRI (for the chest, abdomen or pelvis) within 6 weeks prior to [18F]Florastamin PET/CT scanning will be collected. All conventional imaging examinations will be evaluated by the study site. At the time of whole-body bone scanning, examinations will be performed 2 hours after the contrast agent 99mTc-HDP 20 to 30 mCi is administered intravenously. At the time of gadolinium-enhanced MRI scanning (for the chest, abdomen or pelvis), the gadolinium contrast agent (Gadobrix 1 cc/kg) will be administered intravenously.
Biopsy and PLND Images collected through the conventional imaging during the baseline visit can be selectively used for images to guide a biopsy, and images to decide on biopsy sites will be read by the study site. If more than one legions are identified through the image reading, an intermediary radiology specialist will choose a lesion for which to perform a biopsy; however, among the lesions identified, the one determined to be safe for the subject in the investigator's judgment will be preferred as a site on which to perform a biopsy or PLND, and the final biopsy site will be decided after checking its justification through consultation with the intermediary Department of Radiology. A biopsy can be performed while hospitalized, if necessary. Pelvic lymph node dissection (PLND) is surgery to remove the lymph nodes from the pelvis, which is part of a radical prostatectomy, so it is typically performed with hospitalization.
Florastamin PET imaging (PSMA-PET Imaging) Uptake values of [18F]Florastamin in the region of interest (ROI) of Florastamin PET imaging are evaluated by an independent evaluator. The independent evaluator records all uptake values observed in the lesion, and analyzes uptake values in the lesion where the biopsy has been performed during analysis of efficacy evaluation.
Biopsy and Histopathology Tissues removed through a biopsy or PLND are delivered to the Department of Pathology in accordance with the guidelines of the study site and slides by biopsy or PLND site are produced. A pathologist at the study site performs histopathological evaluation of the slides produced with blinded to results of [18F]Florastamin PET/CT examinations. An area on which a biopsy or PLND has been performed and histopathological results thereof are collected in the eCRF.
Histopathology truth standard Tissues removed with a standard method in more than one lesion locations confirmed by the conventional imaging performed prior to [18F]Florastamin PET/CT scanning are evaluated in terms of whether there is prostate cancer, there are any other tumors, it is impossible to read, etc. In addition, the positive/negative result of [18F]Florastamin PET/CT imaging in the applicable location is evaluated by an independent evaluator.

Conditions: High Risk Prostate Carcinoma
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 intravenously administered only to the subjects who meet the inclusion/exclusion criteria, and then [F-18]Florastamin PET/CT imaging is performed from the head to thigh after 105 ± 15 minutes (care should be taken to prevent extravasation of the radiopharmaceutical product).

Study groups in NCT05936658
Study group	Role	What they receive
The positive predictive values (PPV) of [18F]Florastamin PET/CT imaging	Other	The positive predictive values (PPV) of [18F]Florastamin PET/CT imaging for the detection of recurrent or metastatic prostate cancer in subjects are evaluated. Receives: Drug: [F-18]Florastamin

What is being measured

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

The positive predictive values(PPV) Evaluation of [18F]Florastamine PET/CT
The positive predictive values (PPV) of [18F]Florastamin PET/CT imaging for the detection of recurrent or metastatic prostate cancer in subjects are evaluated. The PPV is calculated by TP/(TP+FP) x 100% for patients with positive [ 18F]Florastamin PET/CT. True positive is defined as being determined to be positive for prostate cancer according to histopathological results of tissues removed from [18F]Florastamin PET/CT and a biopsy or PLND. False positive is defined as being determined negative for prostate cancer according to the histopathological results of tissues removed through a biopsy or PLND, but determined positive for prostate cancer by [18F]Florastamin PET/CT.
Measured: [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).

Secondary outcomes (5)

Detection rates of [18F]Florastamin PET/CT imaging
Detection rates of [18F]Florastamin PET/CT imaging in the lesion location (prostate, bones, lymph nodes (inside and outside the pelvis), soft tissues, etc.) are evaluated. Detection rates of [18F]Florastamin PET/CT imaging are defined as the percentage of subjects who have tested positive according to the [18F]Florastamin PET/CT imaging results in any random lesion location such as prostate, bones, lymph nodes (inside and outside the pelvis), and soft tissues.
Measured: [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).
The sensitivity of [18F]Florastamin PET/CT imaging
The sensitivity of [18F]Florastamin PET/CT imaging for the detection of recurrent or metastatic prostate cancer in subjects is evaluated. The sensitivity is calculated by TP/(TP+FN) x 100% for patients with positive [18F]Florastamin PET/CT. True positive is defined as being determined to be positive for prostate cancer according to [ 18F]Florastamin PET/CT and histopathological results. False positive is defined as being determined negative for prostate cancer according to the histopathological results but determined positive for prostate cancer by [18F]Florastamin PET/CT.
Measured: [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).
The positive predictive values (PPV) Comparison of [18F]Florastamin PET/CT imaging and conventional imaging
The positive predictive values (PPV) of [18F]Florastamin PET/CT imaging and of the conventional imaging (whole-body bone scan, CT, MRI or ultrasound) are compared and evaluated to detect recurrent or metastatic prostate cancer in subjects.
Measured: [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).
Evaluation of the standard uptake values of [18F]Florastamin in the lesion location
Standard uptake values (SUVpeak, SUVmax, and SUVr) of [18F]Florastamin for each lesion location (prostate, bones, lymph nodes (inside and outside the pelvis), soft tissues, etc.) decided on by the independent evaluator according to the histopathological results (positive and negative for prostate cancer) are evaluated.
Measured: [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).
Percentage of subjects who found a different lesion in conventional imaging
The percentage of subjects who have a different lesion location found by [18F]Florastamin PET/CT that was not identified through the conventional imaging but a biopsy conducted there has confirmed the lesion is evaluated.
Measured: Conventional imaging conduct at V1(-42 Days ~ 1 Days). [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).

Timeline

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

8 May 2023Jun 2025

First posted10 Jul 2023
Study start8 May 2023
Primary completionJun 2025 (estimated)
Study completionJun 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (57)Papers the sponsor has linked to this study.
Other trials for High Risk Prostate CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Masking: None (open label)
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05936658
Sponsor's protocol ID: FC303-3-2
Status last verified: Mar 2025
First submitted: 21 Jun 2023
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

Amling CL, Blute ML, Bergstralh EJ, Seay TM, Slezak J, Zincke H. Long-term hazard of progression after radical prostatectomy for clinically localized prostate cancer: continued risk of biochemical failure after 5 years. J Urol. 2000 Jul;164(1):101-5.
PubMed 10840432
Antonarakis ES, Feng Z, Trock BJ, Humphreys EB, Carducci MA, Partin AW, Walsh PC, Eisenberger MA. The natural history of metastatic progression in men with prostate-specific antigen recurrence after radical prostatectomy: long-term follow-up. BJU Int. 2012 Jan;109(1):32-9. doi: 10.1111/j.1464-410X.2011.10422.x. Epub 2011 Jul 20.
PubMed 21777360
Bach-Gansmo T, Nanni C, Nieh PT, Zanoni L, Bogsrud TV, Sletten H, Korsan KA, Kieboom J, Tade FI, Odewole O, Chau A, Ward P, Goodman MM, Fanti S, Schuster DM, Willoch F. Multisite Experience of the Safety, Detection Rate and Diagnostic Performance of Fluciclovine (18F) Positron Emission Tomography/Computerized Tomography Imaging in the Staging of Biochemically Recurrent Prostate Cancer. J Urol. 2017 Mar;197(3 Pt 1):676-683. doi: 10.1016/j.juro.2016.09.117. Epub 2016 Oct 13.
PubMed 27746282
Bauman G, Martin P, Thiessen JD, Taylor R, Moussa M, Gaed M, Rachinsky I, Kassam Z, Chin J, Pautler S, Lee TY, Valliant JF, Ward A. [18F]-DCFPyL Positron Emission Tomography/Magnetic Resonance Imaging for Localization of Dominant Intraprostatic Foci: First Experience. Eur Urol Focus. 2018 Sep;4(5):702-706. doi: 10.1016/j.euf.2016.10.002. Epub 2016 Oct 26.
PubMed 28753797
Blomqvist L, Carlsson S, Gjertsson P, Heintz E, Hultcrantz M, Mejare I, Andren O. Limited evidence for the use of imaging to detect prostate cancer: a systematic review. Eur J Radiol. 2014 Sep;83(9):1601-6. doi: 10.1016/j.ejrad.2014.06.028. Epub 2014 Jul 5.
PubMed 25059597
Bluemel C, Krebs M, Polat B, Linke F, Eiber M, Samnick S, Lapa C, Lassmann M, Riedmiller H, Czernin J, Rubello D, Bley T, Kropf S, Wester HJ, Buck AK, Herrmann K. 68Ga-PSMA-PET/CT in Patients With Biochemical Prostate Cancer Recurrence and Negative 18F-Choline-PET/CT. Clin Nucl Med. 2016 Jul;41(7):515-21. doi: 10.1097/RLU.0000000000001197.
PubMed 26975008
Calais J, Ceci F, Eiber M, Hope TA, Hofman MS, Rischpler C, Bach-Gansmo T, Nanni C, Savir-Baruch B, Elashoff D, Grogan T, Dahlbom M, Slavik R, Gartmann J, Nguyen K, Lok V, Jadvar H, Kishan AU, Rettig MB, Reiter RE, Fendler WP, Czernin J. 18F-fluciclovine PET-CT and 68Ga-PSMA-11 PET-CT in patients with early biochemical recurrence after prostatectomy: a prospective, single-centre, single-arm, comparative imaging trial. Lancet Oncol. 2019 Sep;20(9):1286-1294. doi: 10.1016/S1470-2045(19)30415-2. Epub 2019 Jul 30.
PubMed 31375469
Calais J, Fendler WP, Herrmann K, Eiber M, Ceci F. Comparison of 68Ga-PSMA-11 and 18F-Fluciclovine PET/CT in a Case Series of 10 Patients with Prostate Cancer Recurrence. J Nucl Med. 2018 May;59(5):789-794. doi: 10.2967/jnumed.117.203257. Epub 2017 Dec 14.
PubMed 29242404
Castellucci P, Fuccio C, Nanni C, Santi I, Rizzello A, Lodi F, Franceschelli A, Martorana G, Manferrari F, Fanti S. Influence of trigger PSA and PSA kinetics on 11C-Choline PET/CT detection rate in patients with biochemical relapse after radical prostatectomy. J Nucl Med. 2009 Sep;50(9):1394-400. doi: 10.2967/jnumed.108.061507. Epub 2009 Aug 18.
PubMed 19690023
Chang SS. Overview of prostate-specific membrane antigen. Rev Urol. 2004;6 Suppl 10(Suppl 10):S13-8.
PubMed 16985927
Chausse G, Niazi T, Abikhzer GS, Probst SM. Biopsy-Proven Diffuse Mediastinal Prostate Cancer Metastases Negative on 18F-Fluorocholine, Diagnosed on 68Ga-PSMA and 18F-PSMA PET/CT. Clin Nucl Med. 2017 Oct;42(10):801-802. doi: 10.1097/RLU.0000000000001766.
PubMed 28719448
Chen Y, Pullambhatla M, Foss CA, Byun Y, Nimmagadda S, Senthamizhchelvan S, Sgouros G, Mease RC, Pomper MG. 2-(3-1-Carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl-ureido)-pentanedioic acid, [18F]DCFPyL, a PSMA-based PET imaging agent for prostate cancer. Clin Cancer Res. 2011 Dec 15;17(24):7645-53. doi: 10.1158/1078-0432.CCR-11-1357. Epub 2011 Oct 31.
PubMed 22042970
de Jong IJ, Pruim J, Elsinga PH, Vaalburg W, Mensink HJ. 11C-choline positron emission tomography for the evaluation after treatment of localized prostate cancer. Eur Urol. 2003 Jul;44(1):32-8; discussion 38-9. doi: 10.1016/s0302-2838(03)00207-0.
PubMed 12814672
Dietlein M, Kobe C, Kuhnert G, Stockter S, Fischer T, Schomacker K, Schmidt M, Dietlein F, Zlatopolskiy BD, Krapf P, Richarz R, Neubauer S, Drzezga A, Neumaier B. Comparison of [(18)F]DCFPyL and [ (68)Ga]Ga-PSMA-HBED-CC for PSMA-PET Imaging in Patients with Relapsed Prostate Cancer. Mol Imaging Biol. 2015 Aug;17(4):575-84. doi: 10.1007/s11307-015-0866-0.
PubMed 26013479
Eiber M, Maurer T, Souvatzoglou M, Beer AJ, Ruffani A, Haller B, Graner FP, Kubler H, Haberkorn U, Eisenhut M, Wester HJ, Gschwend JE, Schwaiger M. Evaluation of Hybrid (6)(8)Ga-PSMA Ligand PET/CT in 248 Patients with Biochemical Recurrence After Radical Prostatectomy. J Nucl Med. 2015 May;56(5):668-74. doi: 10.2967/jnumed.115.154153. Epub 2015 Mar 19.
PubMed 25791990

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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 in Patients With Suspected Recurrent or Metastatic Prostate Cancer
ClinicalTrials.gov ID: NCT05936658
Acronym / sponsor ID: FC303-3-2
Conditions: High Risk Prostate Carcinoma
Keywords: Prostate Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 138 participants (actual)
Lead sponsor: FutureChemIndustry (pharma, biotech, devices)
Study start: 8 May 2023 (actual)
Primary completion: Jun 2025 (estimated)
Study completion: Jun 2025 (estimated)
First posted: 10 Jul 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Baseline Procedures At the baseline visit, the conventional imaging will be performed. The results of whole-body bone scan and gadolinium-enhanced MRI (for the chest, abdomen or pelvis) within 6 weeks prior to [18F]Florastamin PET/CT scanning will be collected. All conventional imaging examinations will be evaluated by the study site. At the time of whole-body bone scanning, examinations will be performed 2 hours after the contrast agent 99mTc-HDP 20 to 30 mCi is administered intravenously. At the time of gadolinium-enhanced MRI scanning (for the chest, abdomen or pelvis), the gadolinium contrast agent (Gadobrix 1 cc/kg) will be administered intravenously.
Biopsy and PLND Images collected through the conventional imaging during the baseline visit can be selectively used for images to guide a biopsy, and images to decide on biopsy sites will be read by the study site. If more than one legions are identified through the image reading, an intermediary radiology specialist will choose a lesion for which to perform a biopsy; however, among the lesions identified, the one determined to be safe for the subject in the investigator's judgment will be preferred as a site on which to perform a biopsy or PLND, and the final biopsy site will be decided after checking its justification through consultation with the intermediary Department of Radiology. A biopsy can be performed while hospitalized, if necessary. Pelvic lymph node dissection (PLND) is surgery to remove the lymph nodes from the pelvis, which is part of a radical prostatectomy, so it is typically performed with hospitalization.
Florastamin PET imaging (PSMA-PET Imaging) Uptake values of [18F]Florastamin in the region of interest (ROI) of Florastamin PET imaging are evaluated by an independent evaluator. The independent evaluator records all uptake values observed in the lesion, and analyzes uptake values in the lesion where the biopsy has been performed during analysis of efficacy evaluation.
Biopsy and Histopathology Tissues removed through a biopsy or PLND are delivered to the Department of Pathology in accordance with the guidelines of the study site and slides by biopsy or PLND site are produced. A pathologist at the study site performs histopathological evaluation of the slides produced with blinded to results of [18F]Florastamin PET/CT examinations. An area on which a biopsy or PLND has been performed and histopathological results thereof are collected in the eCRF.
Histopathology truth standard Tissues removed with a standard method in more than one lesion locations confirmed by the conventional imaging performed prior to [18F]Florastamin PET/CT scanning are evaluated in terms of whether there is prostate cancer, there are any other tumors, it is impossible to read, etc. In addition, the positive/negative result of [18F]Florastamin PET/CT imaging in the applicable location is evaluated by an independent evaluator.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
The positive predictive values (PPV) of [18F]Florastamin PET/CT imaging	Other	Drug: [F-18]FlorastaminThe positive predictive values (PPV) of [18F]Florastamin PET/CT imaging for the detection of recurrent or metastatic prostate cancer in subjects are evaluated.

Who may qualify

Ages: 19 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (20 listed)

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:
Subjects who are suffering from active infectious disease at screening and determined unfit to participate in this study;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
[F-18]FlorastaminA single dose of [F-18]Florastamin at 10 ± 1 mCi is intravenously administered only to the subjects who meet the inclusion/exclusion criteria, and then [F-18]Florastamin PET/CT imaging is performed from the head to thigh after 105 ± 15 minutes (care should be taken to prevent extravasation of the radiopharmaceutical product).	Drug	The positive predictive values (PPV) of [18F]Florastamin PET/CT imaging

Primary outcome

The positive predictive values(PPV) Evaluation of [18F]Florastamine PET/CT
Time frame: [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).
The positive predictive values (PPV) of [18F]Florastamin PET/CT imaging for the detection of recurrent or metastatic prostate cancer in subjects are evaluated. The PPV is calculated by TP/(TP+FP) x 100% for patients with positive [ 18F]Florastamin PET/CT. True positive is defined as being determined to be positive for prostate cancer according to histopathological results of tissues removed from [18F]Florastamin PET/CT and a biopsy or PLND. False positive is defined as being determined negative for prostate cancer according to the histopathological results of tissues removed through a biopsy or PLND, but determined positive for prostate cancer by [18F]Florastamin PET/CT.

5 secondary outcomes

Detection rates of [18F]Florastamin PET/CT imaging
Time frame: [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).
The sensitivity of [18F]Florastamin PET/CT imaging
Time frame: [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).
The positive predictive values (PPV) Comparison of [18F]Florastamin PET/CT imaging and conventional imaging
Time frame: [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).
Evaluation of the standard uptake values of [18F]Florastamin in the lesion location
Time frame: [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).
Percentage of subjects who found a different lesion in conventional imaging
Time frame: Conventional imaging conduct at V1(-42 Days ~ 1 Days). [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
Background: PubMed 10840432Amling CL, Blute ML, Bergstralh EJ, Seay TM, Slezak J, Zincke H. Long-term hazard of progression after radical prostatectomy for clinically localized prostate cancer: continued risk of biochemical failure after 5 years. J Urol. 2000 Jul;164(1):101-5.
Background: PubMed 21777360Antonarakis ES, Feng Z, Trock BJ, Humphreys EB, Carducci MA, Partin AW, Walsh PC, Eisenberger MA. The natural history of metastatic progression in men with prostate-specific antigen recurrence after radical prostatectomy: long-term follow-up. BJU Int. 2012 Jan;109(1):32-9. doi: 10.1111/j.1464-410X.2011.10422.x. Epub 2011 Jul 20.
Background: PubMed 27746282Bach-Gansmo T, Nanni C, Nieh PT, Zanoni L, Bogsrud TV, Sletten H, Korsan KA, Kieboom J, Tade FI, Odewole O, Chau A, Ward P, Goodman MM, Fanti S, Schuster DM, Willoch F. Multisite Experience of the Safety, Detection Rate and Diagnostic Performance of Fluciclovine (18F) Positron Emission Tomography/Computerized Tomography Imaging in the Staging of Biochemically Recurrent Prostate Cancer. J Urol. 2017 Mar;197(3 Pt 1):676-683. doi: 10.1016/j.juro.2016.09.117. Epub 2016 Oct 13.
Background: PubMed 28753797Bauman G, Martin P, Thiessen JD, Taylor R, Moussa M, Gaed M, Rachinsky I, Kassam Z, Chin J, Pautler S, Lee TY, Valliant JF, Ward A. [18F]-DCFPyL Positron Emission Tomography/Magnetic Resonance Imaging for Localization of Dominant Intraprostatic Foci: First Experience. Eur Urol Focus. 2018 Sep;4(5):702-706. doi: 10.1016/j.euf.2016.10.002. Epub 2016 Oct 26.
Background: PubMed 25059597Blomqvist L, Carlsson S, Gjertsson P, Heintz E, Hultcrantz M, Mejare I, Andren O. Limited evidence for the use of imaging to detect prostate cancer: a systematic review. Eur J Radiol. 2014 Sep;83(9):1601-6. doi: 10.1016/j.ejrad.2014.06.028. Epub 2014 Jul 5.
Background: PubMed 26975008Bluemel C, Krebs M, Polat B, Linke F, Eiber M, Samnick S, Lapa C, Lassmann M, Riedmiller H, Czernin J, Rubello D, Bley T, Kropf S, Wester HJ, Buck AK, Herrmann K. 68Ga-PSMA-PET/CT in Patients With Biochemical Prostate Cancer Recurrence and Negative 18F-Choline-PET/CT. Clin Nucl Med. 2016 Jul;41(7):515-21. doi: 10.1097/RLU.0000000000001197.
Background: PubMed 31375469Calais J, Ceci F, Eiber M, Hope TA, Hofman MS, Rischpler C, Bach-Gansmo T, Nanni C, Savir-Baruch B, Elashoff D, Grogan T, Dahlbom M, Slavik R, Gartmann J, Nguyen K, Lok V, Jadvar H, Kishan AU, Rettig MB, Reiter RE, Fendler WP, Czernin J. 18F-fluciclovine PET-CT and 68Ga-PSMA-11 PET-CT in patients with early biochemical recurrence after prostatectomy: a prospective, single-centre, single-arm, comparative imaging trial. Lancet Oncol. 2019 Sep;20(9):1286-1294. doi: 10.1016/S1470-2045(19)30415-2. Epub 2019 Jul 30.
Background: PubMed 29242404Calais J, Fendler WP, Herrmann K, Eiber M, Ceci F. Comparison of 68Ga-PSMA-11 and 18F-Fluciclovine PET/CT in a Case Series of 10 Patients with Prostate Cancer Recurrence. J Nucl Med. 2018 May;59(5):789-794. doi: 10.2967/jnumed.117.203257. Epub 2017 Dec 14.
Background: PubMed 19690023Castellucci P, Fuccio C, Nanni C, Santi I, Rizzello A, Lodi F, Franceschelli A, Martorana G, Manferrari F, Fanti S. Influence of trigger PSA and PSA kinetics on 11C-Choline PET/CT detection rate in patients with biochemical relapse after radical prostatectomy. J Nucl Med. 2009 Sep;50(9):1394-400. doi: 10.2967/jnumed.108.061507. Epub 2009 Aug 18.
Background: PubMed 16985927Chang SS. Overview of prostate-specific membrane antigen. Rev Urol. 2004;6 Suppl 10(Suppl 10):S13-8.
Background: PubMed 28719448Chausse G, Niazi T, Abikhzer GS, Probst SM. Biopsy-Proven Diffuse Mediastinal Prostate Cancer Metastases Negative on 18F-Fluorocholine, Diagnosed on 68Ga-PSMA and 18F-PSMA PET/CT. Clin Nucl Med. 2017 Oct;42(10):801-802. doi: 10.1097/RLU.0000000000001766.
Background: PubMed 22042970Chen Y, Pullambhatla M, Foss CA, Byun Y, Nimmagadda S, Senthamizhchelvan S, Sgouros G, Mease RC, Pomper MG. 2-(3-1-Carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl-ureido)-pentanedioic acid, [18F]DCFPyL, a PSMA-based PET imaging agent for prostate cancer. Clin Cancer Res. 2011 Dec 15;17(24):7645-53. doi: 10.1158/1078-0432.CCR-11-1357. Epub 2011 Oct 31.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jae Young Joung, Ph.D principal investigator

National Cancer Center

6 sites in 1 country: see every site and its status.

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 6 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 5 inclusion and 20 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 6 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?

The positive predictive values(PPV) Evaluation of [18F]Florastamine PET/CT (time frame: [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).). 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 NCT05936658, which also lists 57 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.