Phase I/IIa trial of Ga-68 PSMA-11 produced on the MPS200 PSMA-Ga automated synthesizer

JRCT ID: jRCT2022230014

Registered date:01/07/2023

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

Healthy adult male
Prostate cancer

• Date of first enrollment: 25/07/2023
• Target sample size: 9
• Study type: Interventional
• Intervention(s): Ga-68 PSMA-11 injection solution 4.0 MBq/kg will be administered as a single bolus intravenous dose. After administration, PET/CT imaging will be performed for 360 minutes.

Outcome(s)

Primary Outcome

The number and percentage of the following occurrences will be calculated as safety endpoints
- Ga-68 PSMA-11 Injection adverse events from the time of administration, during imaging, and up to 7 days after administration
- Abnormal findings on physical examination performed at the defined time points
- Abnormal values in laboratory tests (serum biochemistry, blood tests, urinalysis) performed at the defined time points
- Abnormal findings on electrocardiogram performed at the defined time point
- Abnormal vital signs (blood pressure, heart rate, body temperature, oxygen saturation) at the defined time points
- Failure of investigational device

Secondary Outcome

1) Radioactive pharmacokinetics
2) Urinary emission rate of radioactivity
3) Whole body internal dose and effective dose (E)
4) Imaging evaluation

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Male

Include criteria

(Step 1)
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
(Step 2)
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
(Step 3)
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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Shiga Tohru