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Prospective, Multi-Center Study to Assess the Diagnostic Performance of 18F-PSMA-1007 PET/CT Imaging in Patients with Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer (18F-PSMA-1007 PET/CT in prostate cancer)

Prospective, Multi-Center Study to Assess the Diagnostic Performance of 18F-PSMA-1007 PET/CT Imaging in Patients with Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer

Ueno Satoshi

Sumitomo Heavy Industries, Ltd.

2-1-1 Osaki, Shinagawa-ku, Tokyo

satoshi.ueno@shi-g.com

Tanizaki Naoaki

Sumitomo Heavy Industries, Ltd.

2-1-1 Osaki, Shinagawa-ku, Tokyo

+81-3-6737-2570

naoaki.tanizaki@shi-g.com

Recruiting

Mar. 12, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

(1) The patient (male) is aged 18 years or above.
(2) The patient is able to understand the information presented to him concerning the nature, scope, and consequences of the trial as set out in the information provided to the patient AND has provided written informed consent to participate.
(3) The patient has newly diagnosed, biopsy-proven, clinically localized prostate adenocarcinoma, and curative prostatectomy with extended pelvic lymph node dissection is his preferred course of treatment.
(4) The patient has at least high-risk disease as defined by the NCCN guidelines (version 1.2023). That is, the presence of any one or more of the following:
-Overall ISUP grade group 4 or 5,
-Clinical category T3a or greater,
-Serum PSA level greater than 20 ng/ml.
(5)The patient has undergone conventional imaging (CT or MRI, and bone scan if clinically indicated) to detect the presence of pelvic nodal involvement and bone or visceral metastases within 60 days of the planned PET-CT procedure.

(1) Patients for whom radical prostatectomy is not clinically appropriate or the patient is otherwise unlikely to undergo radical prostatectomy with extensive pelvic lymph node dissection.
(2) The patient has received any therapy - be it radiation, surgical or drug therapy - for his prostate cancer.
(3) The patient has any contraindication(s) for and/or known hypersensitivity to any constituent(s) of [18F]PSMA-1007.
(4) The patient is not able to have PET-CT scans (for example, because of weight, claustrophobia, or inability to lie still for the duration of the scan).
(5) The patient is closely affiliated to the investigation site; e.g., is a first-degree relative of the investigator.
(6) At the time of screening, the patient is receiving any other investigational agent(s), or he has received any such agent(s) within the previous 30 days, or he is scheduled to receive any such agent(s) in the period up to the planned date for the last study visit.
(7) Patients who were enrolled in this clinical trial but withdrew for some reason.
(8) The patient has previously undergone PET imaging with any PSMA-avid product.
(9) The patient has histological evidence of small-cell carcinoma of the prostate.
(10) The patient is clinically unstable or requires emergency treatment.
(11) The patient is part of a vulnerable population, e.g., but not limited to the patient is incapacitated in such a way that renders him incapable of understanding the nature, scope, and consequences of the trial as set out in the information given to the patient.

Male

newly diagnosed and biopsy-confirmed prostate adenocarcinoma

A single intravenous injection of 18F-PSMA-1007 as a radiation dose of 3.7 MBq/kg body weight
(plus or minus 10%), followed by a flush with 10 mL of saline for injection, so that the total radiation dose does
not exceed 296 MBq or 10 mL of administered solution.

The determination of pelvic lymph node metastasis by histopathology results is considered SOT, and the diagnostic performance (sensitivity, specificity) of 18F-PSMA-1007 PET/CT is evaluated on a site-based patient basis (accurate diagnosis of at least hemi-pelvis).

(1) The determination of pelvic lymph node metastasis by histopathological examination results is defined as SOT, and the diagnostic performance (sensitivity, specificity) of 18F-PSMA-1007 PET/CT is evaluated on a patient-by-patient basis.
(2) The determination of pelvic lymph node metastasis by histopathology results is defined as SOT, and the diagnostic performance (sensitivity, specificity) of 18F-PSMA-1007 PET/CT is evaluated on a region basis (each hemipelvis is evaluated separately) and a small-site basis (six small pelvic sites: internal iliac left/right, external iliac left/right, obturator left/right).
(3) The determination of pelvic lymph node metastasis based on histopathology results is defined as SOT, and the diagnostic performance of 18F-PSMA-1007 PET/CT is evaluated in comparison with the diagnostic performance of conventional imaging modalities (on a patient-by-patient basis, using an independent assessment by 3 readers blinded to the clinical data).
(4) The SOT is the determination of pelvic lymph node metastasis based on histopathology results, and the diagnostic performance (PPV and NPV) of 18F-PSMA-1007 PET/CT is evaluated on a patient- and site-specific basis.
(5) Evaluate intra- and inter-reader agreement on the results of the 18F-PSMA-1007 PET/CT evaluation by three independent readers.

+81-3-3542-2511

Mar. 03, 2025

+81-6-6210-8290

Mar. 03, 2025

+81-3-3433-1111

Mar. 03, 2025

No

Germany/France/Italy/Netherlands/Spain/USA