68Ga-THP-PSMA PET/CT in Prostate Cancer: Clinical Stage and Restage

Shanghai Jiao Tong University

Status and phase: Completed; Early Phase 1

Conditions: Prostate Cancer

Treatments: Drug: 68Ga-Labeled PSMA; Drug: Non-labeled PSMA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04158817

[2018]15

Details and patient eligibility

About

To evaluate the dosimetry, safety and the detection rate of 68Ga-THP-PSMA PET/CT for identifying the site of prostate cancer metastasis and relapse. It is also to evaluate the association of clinical/pathologic features and 68Ga-THP-PSMA PET/CT detection rate and compare 68Ga-THP-PSMA PET/CT with other imaging procedure.

Enrollment: 8 patients

Sex: Male

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult male, age 18 years or older
2. Prior diagnosis of prostatic cancer
3. Willing to participate in this study and given written informed consent
4. AST, ALT, BUN, Cr not more than double the normal values
5. Subjects of childbearing potential must be willing to undergo a pregnancy test prior to enrolment

Exclusion criteria

1. Subjects with pacemakers
2. Hepatitis B virus infection (including carriers) at screening, i.e. hepatitis B surface antigen (HBsAg) positive, or hepatitis C antibody (anti-HCV) positive, or acquired immunodeficiency disease (HIV) infected, or serum syphilis positive person
3. Abnormal liver function during baseline screening period: AST or ALT> 2 times the upper limit of normal value (ULN), if the marginal increase of a single index is judged as having no clinical significance by the investigator, it can be retested during the screening period. Once, if more than 2 times ULN after retesting, consider enrolling).
4. Impaired renal function during screening: serum creatinine or urea nitrogen > 1.5 times ULN.
5. Within 4 months prior to the baseline screening period, myocardial infarction or other cardiac events requiring hospitalization (unstable angina, etc.), cerebrovascular accident, transient ischemic attack, acute congestive Heart failure or severe arrhythmia (ventricular arrhythmia, atrioventricular block above II)
6. Subjects with pulmonary embolism or deep vein thrombosis
7. Various infections that the investigators consider unsuitable for study, including but not limited to patients with various infections requiring further treatment, such as urinary tract infections, respiratory infections, and diabetic foot infections.
8. Patients with abnormal thyroid function during baseline screening period (including but not limited to active hyperthyroidism, hypothyroidism or Hashimoto's thyroiditis)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Experimental Arm

Experimental group

Description:

All Prostate cancer patients recruited to the study will be administered 2.11 MBq/kg of 68Ga-THP-PSMA in a single dose injection.

Treatment:

Drug: Non-labeled PSMA

Drug: 68Ga-Labeled PSMA