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

Last updated: March 10, 2025
Sponsor: FutureChem
Overall Status: Active - Not Recruiting

Phase

3

Condition

Prostate Cancer

Prostate Disorders

Urologic Cancer

Treatment

[F-18]Florastamin

Clinical Study ID

NCT05936658
FC303-3-2
  • Ages > 19
  • Male

Study 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 through the conventional imaging.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male aged 19 and older

  2. Patients histopathologically diagnosed with prostate cancer

  3. Patients who can undergo a percutaneous biopsy or PLND for more than one lesionlocations with locally recurrent, new or advanced metastasis as confirmed by MRI orwhole-body bone scan performed within 6 weeks prior to screening

  4. Patients whose survival is expected to be at least 6 months with ECOG PerformanceStatus ≤ 2

  5. Those whose ICF was signed by themselves or their legal guardian or representativeafter sufficient explanation was given by the investigator about the studyobjectives, details, characteristics of the investigational device, etc. beforeenrolled for the study.

Exclusion

Exclusion Criteria:

  1. 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 NewYork Heart Association;

  • Embolism pulmonary, acute coronary syndrome (unstable angina or myocardialinfarction);

  • Acute severe respiratory syndrome;

  • Cerebrovascular disease such as stroke;

  • Uncontrollable hypertension (SBP > 160 mmHg or DBP > 90 mmHg);

  • Uncontrollable heart arrhythmia;

  • Blood clotting disorder.

  1. Patients who are receiving radiation therapy or ablative therapy on the prostate bedwithin 12 weeks prior to screening

  2. Patients whose method of systemic treatment for prostate cancer (e.g., hormonetherapy, biological therapy, radiation therapy, or chemotherapy) has changed within 3 months prior to screening, or who have to change orstart systemic treatment forprostate cancer while the study is being conducted (until before a biopsy or PLND)However, when systemic treatment has changed into watchful waiting, the patient canparticipate in the study.

  3. 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 whosehepatic metastasis has been confirmed, AST and ALT > 5 x ULN).

  1. Subjects who are suffering from active infectious disease at screening anddetermined unfit to participate in this study;

  2. Subjects with solid tumors other than prostate cancer or hematologic malignanciesincluding lymphoma within 3 years prior to screening (however, they can be enrolledin the case of properly treated non-melanoma skin cancer)

  3. 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

  4. Subjects with hypersensitivity to radioisotopes

  5. Subjects who participate in other clinical studies that may affect image obtainmentfrom [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 mainlythrough simple follow-up without administration of IP from the time of enrollmentfor the study until the end)

  6. Subjects who cannot undergo necessary imaging examinations due to medical conditionsor other conditions (serious claustrophobia, radiophobia, etc.) that undermine thesubject safety or compliance status for generating reliable data or completing thestudy in the principal investigator's judgment

Study Design

Total Participants: 138
Treatment Group(s): 1
Primary Treatment: [F-18]Florastamin
Phase: 3
Study Start date:
May 08, 2023
Estimated Completion Date:
June 30, 2025

Study 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Connect with a study center

  • National Cancer Center

    Gyeonggi-do,
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ewha womans university mokdong medical center

    Soeul,
    Korea, Republic of

    Site Not Available

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