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Japanese

Jan. 14, 2025

Jan. 16, 2026

jRCTs041240164

A single-center, open-label study to evaluate the safty of [68Ga] PSMA-11 PET CT in the diagnosis of prostate cancer

[68Ga] PSMA-11 PET CT in the diagnosis of prostate cancer

Shiroki Ryoichi

Fujita Health University Hospital

1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi

+81-562-93-2111

rshiroki@fujita-hu.ac.jp

Shiroki Ryoichi

Fujita Health University Hospital

1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi

+81-562-93-2111

rshiroki@fujita-hu.ac.jp

Recruiting

Jan. 14, 2025

200

Interventional

single arm study

open(masking not used)

historical control

single assignment

diagnostic purpose

1. Patients who have been fully informed of the study and have given their voluntary written consent based on their full understanding.
2. Patients aged 20 to 85 years at the time of consent
3. Patients diagnosed with high-risk localized prostate cancer
4. Patients with PSA recurrence after curative treatment for localized prostate cancer
5. Patients diagnosed with non-metastatic castration-resistant prostate cancer
6. Patients diagnosed with metastatic castration-resistant prostate cance

1. Patients who have difficulty maintaining a supine position for the duration of the examination (approximately 20 minutes).
2. Patients who are otherwise deemed inappropriate by the principal investigator or co-investigator.

20age old over
85age old under

Both

Prostate cancer

In-house manufactured [68Ga] PSMA-11 is administered intravenously and PET/CT scans are performed.

prostate cancer, PSMA, PET

015

Adverse events after administration of [68Ga]PSMA-11, including fatigue, nausea, constipation, and vomiting

Fujita Health University Certified Review Board
1-98 Dengakugakubo, Kutsukake-cho,Toyoake-shi,Aichi, Aichi

+81-562-93-2865

crb-f@fujita-hu.ac.jp
Approval

Dec. 16, 2024

none

History of Changes

No Publication date
4 Jan. 16, 2026 (this page) Changes
3 Mar. 04, 2025 Detail Changes
2 Jan. 30, 2025 Detail Changes
1 Jan. 14, 2025 Detail