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Radiopharmaceuticals

The positive predictive values (PPV) of \[18F\]Florastamin PET/CT imaging for the detection of recurrent or metastatic prostate cancer in subjects are evaluated.

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).

[F-18]Florastamin

Chan Soo Park, Ph.D

Jae Young Joung, Ph.D

Sung Gu Kang, Ph.D

Seong Il Seo, Ph.D

Seung Hwan Lee, Ph.D

Ji Youl Lee, Ph.D

Cheong Su Kim, Ph.D

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.

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.

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

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

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.

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.

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.

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.

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.

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.

FutureChem

MRI and \[F-18\]Florastamin PET/CT are performed for each subject.

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.

ChanSoo Park, Ph.D

Seung-Ju Lee, Ph.D

Seok-ho Kang, Ph.D

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.

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.

compare PET/CT Imaging Diagnosis with MRI Diagnosis for one subject

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

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

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.

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

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

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.

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

Neoplastic Cells, Circulating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasm Metastasis

Neoplastic Processes

Hormones

Patients with low or very low risk prostate cancer who have been on active surveillance for 5 or more years with a stable PSA or on active surveillance for 2 or more years with negative multiparametric MRI (mpMRI) or mpMRI with a fusion biopsy(ies) confirming low risk disease.

Men with high-risk localized prostate cancer, defined as stage pT3a or Gleason score greater than or equal to 8 and/or pre-prostatectomy PSA of greater than or equal to 20 ng/mL.

Systemic and/or hormonal treatment naive men with localized prostate cancer (pathological stages pT2, pT3a or pT4 with TNM N0 or N1 and M0 disease) who have clinical suspicion of biochemical recurrence 2 - 5 months following radical prostatectomy and are scheduled to undergo NGI (i.e., Axumin® or PSMA PETCT) within the next 45 days or have already undergone NGI within the past 45 days.

Patients with evidence of non-metastatic castration-resistant prostate cancer (i.e. localized prostate cancer patients with clinical symptoms of disease progression and/or evidence of a rising PSA following hormone therapy) who are scheduled to undergo NGI (i.e., Axumin® or PSMA PETCT) within the next 45 days or have already undergone NGI within the past 45 days and who have not started a new therapy for treatment of their castration-resistant prostate cancer.

Peripheral blood will be collected from each subject at a single time point and data will be collected from a review of each subject's medical records.

Blood collection

Jose G Moreno, MD

This study is designed to evaluate the presence and numbers of circulating tumor cells (CTCs) and cancer related gene expression levels in subjects with localized high-risk prostate cancer (HRLPC) and from subjects with non-metastatic disease experiencing biochemical recurrence and castration-resistance (BCRLPC and NMCRPC groups, respectively) who are about to undergo next generation imaging (NGI, such as Axumin® or PSMA PETCT). The investigators will also evaluate subjects with localized indolent prostate cancer who are on active surveillance (AS) as a control population. The CTC and gene expression results will be evaluated for association with disease state and progression and survival.

Patients who meet the eligibility criteria and provide written informed consent will be enrolled into the study. The four (4) groups of patients to be enrolled into the study will consist of: 1) men with low risk localized prostate cancer (LPC) on active surveillance (AS control group), 2) treatment naïve men with high risk LPC (HRLPC) who are 2 - 5 months out after having a radical prostatectomy, 3) treatment naïve men with biochemically recurrent LPC (BCRLPC) who are about to or have recently undergone next generation imaging \[NGI\] (i.e. Axumin® or PSMA PETCT), and men with non-metastatic castration resistant prostate cancer (NMCRPC) who are about to or have recently undergone NGI (i.e. Axumin® or PSMA PETCT). The goal is to enroll a total of 25 evaluable patients into each study group (HRLPC, BCRLPC, NMCRPC and AS) and collect up to \~29mL of blood from each patient as a single timepoint for evaluation. HRLPC patients will have blood draw 2 - 5 months following their radical prostatectomy procedure, BCRLPC and NMCRPC patients will have their blood drawn within 45 days prior to or after their scheduled NGI study and prior to initiation of a new treatment for their disease, and AS patients will have their blood drawn either after having a stable PSA for greater than 5 years or greater than 2 years after having a biopsy confirming low risk disease. All patients will be followed for up to 2 years after enrollment for disease progression and survival status.

Whole blood samples will be collected, and the following will be isolated from the whole blood samples: serum, plasma, cells (e.g., CTCs, white blood cells, etc.), circulating cell free DNA, DNA and RNA from isolated cells, etc.

Characterization of Circulating Tumor Cells (CTCs) in High Risk and Early Metastatic Prostate Cancer Patients Using Parsortix® System

ANG-015 / MLU-3 (CHARTER Study): Characterization of Circulating Tumor Cells Isolated Using the Parsortix® System in High Risk and Early Metastatic Prostate Cancer Patients

Data from this study will not be shared with other researchers.

The population of cells captured from the peripheral blood samples by the Parsortix system will be evaluated using cytological and/or immunofluorescent staining methods to determine the numbers and phenotypes of any rare cells present (e.g., epithelial and/or mesenchymal CTCs, megakaryocytes, etc. alone and/or in clusters). The numbers and phenotypes of any rare cells present will be evaluated for association with the patient disease state (e.g., study group), the presence of metastatic disease as determined by NGI, and disease progression and/or survival (for up to two years following enrollment).

DNA and/or RNA will be isolated from the population of cells captured from the peripheral blood samples by the Parsortix system and will be evaluated using molecular methods (e.g. multiplex gene expression, mutational analysis, sequencing, etc.) to determine the genotype(s) of the harvested cells. The genotype(s) of any rare cells present will be evaluated for association with the patient disease state (e.g., study group), the presence of metastatic disease as determined by NGI, and disease progression and/or survival (for up to two years following enrollment).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
[18F]Florastamin PET/CT Imaging Examination in Patients With Suspected Recurrent or Metastatic Prostate Cancer	NCT05936658	High Risk Prost...	[F-18]Florastam...	19 Years -	FutureChem
[18F]Florastamin PET/CT Imaging Examination in Patients With Suspected Recurrent or Metastatic Prostate Cancer	NCT05936658	High Risk Prost...	[F-18]Florastam...	19 Years -	FutureChem
Evaluate the Clinical Usefulness of [F-18]Florastamin PET/CT Imaging Diagnosis Compared to MRI Diagnosis	NCT05004285	High Risk Prost...	[F-18]Florastam...	20 Years -	FutureChem
Characterization of Circulating Tumor Cells (CTCs) in High Risk and Early Metastatic Prostate Cancer Patients Using Parsortix® System	NCT05437679	High Risk Prost... Biochemically R... Castration-resi... Prostate Cancer	Blood collectio...	18 Years -	Angle plc

Spots Global Cancer Trial Database for high risk prostate carcinoma