NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2041200110

Registered date:11/03/2021

Phase I study of PSMA-PET

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedProstate cancer
Date of first enrollment24/05/2021
Target sample size10
Countries of recruitment
Study typeInterventional
Intervention(s)A single injection of 2.0 MBq/kg of study drug within 28 days after registration.

Outcome(s)

Primary OutcomeSafety
Secondary OutcomePharmacokinetics Estimated exposure dose

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderMale
Include criteriaCohort 1 1) proven prostate cancer. 2) untreated or progressive high-grade prostate cancer (N1 or M1). Cohort 2 1) proven prostate cancer at initial diagnosis. 2) undergone curative prostatectomy at first onset. 3) satisfying any of the following: 3)-1 biopsy-proven recurrence at local recurrence or metastatic lesion. 3)-2 serum PSMA elevation from baseline. 3)-3 suggestive recurrence by diagnostic imaging. Cohort 3 1) proven prostate cancer at initial diagnosis. 2) undergone curative radiation (external beam and/or brachytherapy) at first onset. 3) satisfying any of the following: 3)-1 biopsy-proven recurrence at local recurrence or metastatic lesion. 3)-2 serum PSMA elevation from baseline. 3)-3 suggestive recurrence by diagnostic imaging. Common to cohort 1 - 3 1) satisfying the following within 28 days before registration: 1)-1 hematopoietic function neutrophil >= 1,500 /microL (G-CSF independent) platelets >= 100,000 /microL (transfusion independent) Hb >= 9.0 g/dL (transfusion independent) 1)-2 renal function eGFR >= 30 mL/min/1.73m2 1)-3 hepatic function ALT < 2.5 time upper limit of normal AST < 2.5 time upper limit of normal T-Bil < 1.5 time upper limit of normal 1)-4 heart function NYHA <= 1 1)-5 respiratory function SpO2 >= 96% (at room air) 2) ECOG PS 0 or 1 within 28 days before registration. 3) 20-year-old and more Japanese males. 4) written agreement to the contraceptives up to 90 days after administration of the study drug. 5) written informed consent to participate in the current clinical trial.
Exclude criteria1) current malignancies other than prostate cancer. 2) HBV (or carrier), HCV, HIV, or any other active infections which need to be treated during the current trial. 3) any complications due to the treatment for prostate cancer which need to be treated during the current trial. 4) any of the following conditions / diseases of poor control. symptomatic congestive heart failure, unstable angina, myocardial infarction, arrythmia, any valvular diseases, any aortic disorders, respiratory disorders (which need to medications or physical treatment such as oxygen administration, continuous positive pressure breathing therapy), interstitial pulmonary disorder, pleural effusion, ascites, hemorrhagic diathesis (e.g., hemophilia, idiopathic thrombocytopenic purpura, antiplatelet therapy, anticoagulant therapy), diabetes mellitus 5) history of salivary gland disorders. 6) history of extra-beam radiation to head and neck area. 7) current poorly-controlled psychiatric disorder. 8) difficulty in complying with the instructions of the investigator in the radiation-controlled area. 9) possibility of administration of radiopharmaceuticals other than the study drug. 10) history of administration of 68Ga-PSMA-11 11) any other reasons that the patient cannot participate in the current clinical trial.

Related Information

Contact

Public contact
Name Anri Inaki
Address 13-1, Takara-machi, Kanazawa Ishikawa Japan 920-8641
Telephone +81-76-265-2333
E-mail henri@staff.kanazawa-u.ac.jp
Affiliation Kanazawa University Hospital
Scientific contact
Name Anri Inaki
Address 13-1, Takara-machi, Kanazawa Ishikawa Japan 920-8641
Telephone +81-76-265-2333
E-mail henri@staff.kanazawa-u.ac.jp
Affiliation Kanazawa University Hospital