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

Phase 1

• Conditions: Healthy Adults and Prostate Cancer Subject

• Registration Number: JPRN-jRCT2032210711
• Lead Sponsor: Tateishi Ukihide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 13

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

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]

Study & Design

• Study Type: Interventional
• Study Design: Not specified