Phase I study of PSMA-PET

JRCT ID: jRCT2041200110

Registered date:11/03/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 24/05/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): A single injection of 2.0 MBq/kg of study drug within 28 days after registration.

Outcome(s)

• Primary Outcome: Safety

Secondary Outcome

Pharmacokinetics
Estimated exposure dose

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

Cohort 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 criteria

1) 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

• Primary Sponsor: Inaki Anri
• Secondary Sponsor: Telix Pharmaceuticals (Japan) Ltd.