Trial Title:
[18F]Florastamin PET/CT Imaging Examination in Patients With Suspected Recurrent or Metastatic Prostate Cancer
NCT ID:
NCT05936658
Condition:
High Risk Prostate Carcinoma
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate Cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[F-18]Florastamin
Description:
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).
Arm group label:
The positive predictive values (PPV) of [18F]Florastamin PET/CT imaging
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.
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.
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.
Criteria for eligibility:
Criteria:
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 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
4. Patients whose survival is expected to be at least 6 months with ECOG Performance
Status ≤ 2
5. 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.
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 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);
- Uncontrollable heart arrhythmia;
- Blood clotting disorder.
2. Patients who are receiving radiation therapy or ablative therapy on the prostate bed
within 12 weeks prior to screening
3. 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.
4. 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).
5. Subjects who are suffering from active infectious disease at screening and
determined unfit to participate in this study;
6. 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)
7. 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
8. Subjects with hypersensitivity to radioisotopes
9. 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)
10. 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
Gender:
Male
Gender based:
Yes
Gender description:
Male aged 19 and older
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center
Address:
City:
Gyeonggi-do
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jae Young Joung, Ph.D
Email:
uroh@ncc.re.kr
Facility:
Name:
Korea University Anam Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sung Gu Kang, Ph.D
Email:
kkangsung76@hanmail.net
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Seong Il Seo, Ph.D
Email:
siseo@skku.edu
Facility:
Name:
Severance Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Seung Hwan Lee, Ph.D
Email:
LEESEH@yuhs.ac
Facility:
Name:
The Catholic University of Korea, Seoul St. Mary's Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Ji Youl Lee, Ph.D
Email:
uroljy@catholic.ac.kr
Facility:
Name:
Ewha womans university mokdong medical center
Address:
City:
Soeul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Cheong Su Kim, Ph.D
Email:
cskim37345806@gmail.com
Start date:
May 8, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
FutureChem
Agency class:
Industry
Source:
FutureChem
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05936658
