Phase I/IIa clinical trial to evaluate the safety, pharmacokinetics, and internal dose of Ga-68 PSMA-11 injection solution produced by the MPS200 PSMA-Ga automated synthesizer and to explore its efficacy in healthy adult males and prostate cancer patients

Shiga Tohru0 个研究点目标入组 9 人开始时间: 2023年7月1日最近更新: 2023年10月17日

试验速览

暂无简介。

•Japanese males aged 18 years and older but under 65 years
•Non-smoker
•BMI between 18 kg/m2 and 28 kg/m2
•Main laboratory values (blood, liver function, renal function, electrolytes, urine) are within normal range.
•(Common to Step 2 and Step 3)
•Age 18 years or older and less than 80 years old
•Patients with histologically diagnosed prostate cancer
•BMI between 18 kg/m2 and 28 kg/m2
•ECOG PS between 0 and 2
•Main laboratory tests (blood, liver and kidney function) are well maintained and within reference values.
•NYHA I or less
•HbA1c less than 8.0
•SpO2 is 96 or higher
•Diagnosed with untreated prostate cancer (including surveillance therapy).
•The patient meets one of the following conditions at the time of screening.
•(1) PSA larger 20 ng/mL or Gleason score larger 8
•Clinical T stage is T2c/T3
•No distant metastasis
•Prostate cancer is being treated.
•PSA is greater than or equal to 0.2 ng/mL.
•Patients must have the following findings on CT within 90 days prior to enrollment, which are considered to be recurrent or metastatic lesions
•(1) Liver metastases for which biopsy under US or CT is possible without puncture of large vessels or lungs.
•(2) Iliac metastases for which CT biopsy without puncture of arteriovenous vessels, intestinal tract, or ureter is possible.

•1) Patients with a history of hypersensitivity to any drug or alcohol.
•2) Have a contraindication to PET/CT examination (e.g., claustrophobia).
•3) Patients with a disease or trauma that may affect pharmacokinetics.
•4) Require treatment for prostate cancer other than hormonal therapy within 7 days of receiving the investigational drug.
•5) Patients must have any of the following infectious diseases and must receive treatment during the study period
•Hepatitis B virus infection
•Hepatitis C virus infection
•HIV infection
•4) Other infectious diseases requiring systemic treatment
•6) Unable to agree to use contraception for 3 months after receiving the investigational drug.
•7) Participation in another clinical trial within 3 months prior to the date of consent
•8) Subjects who are judged by the investigator or subinvestigator to be inappropriate as subjects for this clinical trial.

发起方

Shiga Tohru