68Ga-PSMA-11 PET/CT Visualization of Prostate Cancer in Japanese Participants with BCR

A Prospective, Open-Label, Single-Arm, Intra-Patient, Multicenter Study to Evaluate the Visualization Efficacy and Safety of 68Ga-PSMA-11 PET/CT Compared with Conventional Imaging (CT and Bone Scintillation) in Japanese Patients with Biochemical Recurrent Prostate Cancer that Underwent Radical Treatment.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250473

Enrollment

105

Registered

2025-10-31

Start date

2025-10-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biochemical Recurrence Prostate Cancer

Interventions

111-259 Mbq 68Ga-PSMA-11 prepraed from TLX591-CDx and AX001 is administered to patients, and PET/CT is imaged about 60 minutes after administration.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Understands the contents of the explanation and informed consent document and is able to obtain informed consent in writing. 2. Male over 18 years old at the time of study enrollment. 3. Must be Japanese. 4. Must have histopathologically confirmed adenocarcinoma of the prostate. 5. Must have undergone prior radical total prostatectomy (RP) or radical radiation therapy (RT) for prostate cancer and have experienced biochemical recurrence 6. Karnofsky Performance Status (KPS): 60 or higher. 7. Agrees to practice effective contraceptive methods for at least 28 days after 68Ga-PSMA-11 administration. 8. Adheres to scheduled visits, diagnostic plans, laboratory tests and other study procedures.

Exclusion criteria

Exclusion criteria: 1. History of other malignancies within 1 year. 2. Prior to the administration of 68Ga-PSMA-11, administration of a radionuclide within 10 half-lives of that radionuclide. 3. Participating or planning to participate in a clinical trial of another drug or device during the period of participation in this clinical trial. 4. Within 2 months prior to Day 1 (Day -60 to Day -1), the patient received treatment targeting the androgen pathway. 5. Known hypersensitivity to the active ingredient of 68Ga-PSMA-11 or any of its components. 6. Unable to undergo PET/CT, CT, and bone scintigraphy imaging studies. For example, the patient is unable to lie supine or maintain a supine position during such imaging examinations. 7. Other cases in which the Investigator determines that participation in this study is not appropriate.

Design outcomes

Primary

Measure	Time frame
The sensitivity of 68Ga-PSMA-11 PET/CT and conventional imaging for metastatic prostate cancer in Japanese men presenting with BCR	—

Contacts

Public ContactShuta Yoshino

Telix Pharmaceuticals Japan K.K.

japan.admin@telixpharma.com+81-75-315-8602

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026