A Study to Evaluate the Human Biodistribution and Dosimetry of the Radionuclide Labeled ZT-111 in Patients With Metastatic Prostate Cancer

Fudan University

Status: Enrolling

Conditions: Prostate Specific Membrane Antigen Positive Metastatic Prostate Cancer

Treatments: Radiation: [131I]/[18F]/[68Ga]ZT-111

Study type: Interventional

Funder types: Other

Identifiers

NCT06201741

KY2023-1018

Details and patient eligibility

About

This study is to evaluate the safety, biodistribution, radiation dosimetry and tumor uptake of the [131I]/[18F]/[68Ga]ZT-111 in patients with PSMA positive metastatic prostate cancer.

Enrollment: 10 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18 and 65 years old.
2. Histologically or cytologically confirmed prostate adenocarcinoma with documented history of ≥1 metastatic lesions indicated by imaging.
3. Informed consent must be obtained in writing from the subject, their legally authorized representative, or caregiver.
4. Willing and able to comply with all aspects of this study.

Exclusion criteria

1. Severe hepatic or renal impairment.
2. History of major surgery within the last month.
3. Participation in another concurrent clinical trial.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

[131I]/[18F]/[68Ga]ZT-111

Experimental group

Description:

\[131I\]/\[18F\]/\[68Ga\]ZT-111, single dose

Treatment:

Radiation: [131I]/[18F]/[68Ga]ZT-111