Domestic Phase I/IIa Investigator-initiated Clinical Trials to Evaluate the Safety of 18F-PSMA-1007 in Healthy Adults and Subjects with Prostate Cancer

A Clinical Trial Investigating the Safety of 18F-PSMA-1007 Using a Synthetic Device for PET-Probe 18F-PSMA-1007 Targeting Prostate-Specific Membrane Antigen (PSMA) in Healthy Adults and Prostate Cancer Subjects.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2032210711

Enrollment

Registered

2022-03-31

Start date

2022-03-31

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

Healthy Adults and Prostate Cancer Subject

Interventions

Research on methods for diagnosing diseases. 18F-PSMA-1007 positron emission tomography (Positron Emission Tomography) probe that binds to prostate-specific membrane antigen highly expressed on prosta

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Part A: Healthy adults 1, Japanese men aged 20 or older and under 65 at the time of consent acquisition 2, Individuals with a BMI of 18-28 kg/m2 at screening Part B: Prostate cancer patients 1, Japanese men aged 20 or older and under 80 at the time of consent acquisition 2, Patients with histologically diagnosed prostate cancer 3, Those with a ECOG PS of 0-2 4, Patients with adequate organ function to participate in the clinical trial

Exclusion criteria

Exclusion criteria: Part A: Healthy adults 1, Individuals with a history of hypersensitivity to any drug or alcohol 2, Smokers and smokers who had smoked within 6 months of obtaining informed consent 3. Persons for whom ET/CT examination is contraindicated (persons with claustrophobia, etc.) 4, Individuals weighing more than 80 kg at screening or before administration 5. Individuals who are ill or have trauma that may affect pharmacokinetics Part B: Prostate cancer patients 1.Persons with mental illness (including drug dependence, etc.) and severe renal failure, hepatic dysfunction, or other serious physical illness in the past and at the time of obtaining informed consent 2. Individuals with a history of alcohol hypersensitivity or alcohol dependence 3. Individuals with eGFR<60 at screen 4. Individuals for whom MRIs and PET/CT examinations are contraindicated (persons with metals in the body, persons with tattoos, etc., and persons with claustrophobia, etc.) 5. Those who have difficulty keeping the same entity for inspection time [about 30 minutes]

Design outcomes

Primary

Measure	Time frame
Failure and safety of the investigational device and safety of the PSMA-1007	—

Contacts

Public ContactKoichi Nagata

Tokyo Medical and Dental University

k.nagata.adm@tmd.ac.jp+81-3-5803-4628

Outcome results

None listed

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