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

Gallium-68 Labelled THP-PSMA for the Clinical Stage and Restage of Prostate Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: 68Ga-Labeled PSMA; Drug: Non-labeled PSMA

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm; All Prostate cancer patients recruited to the study will be administered 2.11 MBq/kg of 68Ga-THP-PSMA in a single dose injection.	Drug: 68Ga-Labeled PSMA; All participants in the study will be injected with 68Ga-THP-PSMA at a dose of 2.11 MBq/kg in a single dose injection.; Other Names: 68Ga-THP-PSMA; Drug: Non-labeled PSMA; Patient will be injected with microdose (<100 ug) of THP-PSMA; Other Names: THP-PSMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maximal standard uptake value	The tumor SUVmax of patients will be measured using Region Of Interest.	2 years
The measurement of PSA	The PSA level (ng/mL) of patients will be tested by hemanalysis	2 years
68Ga-THP-PSMA PET/CT in prostate cancer: clinical stage and restage	Visual analysis will be carried out by 4 experienced nuclear medicine physicians to observe the uptake of 68Ga-THP-PSMA in prostate malignant lesions. A 4 point method will be used to interpret the scans for abnormalities. It is categorized as such: score 0, no abnormal increased uptake; score 1, low increased uptake; score 2, moderate increased uptake; score 3, high increased uptake. The lesion will be considered positive for malignancy if the score is 2 or higher.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation analysis	The IHC results of prostate malignant lesions will be used as golden standard to evaluate the sensitivity and specificity of 68Ga-THP-PSMA PET/CT.	2 years
The dosimetry assessment	To evaluate the dosimetry of 68Ga-THP-PSMA, patients (n = 5) will undergo whole-body planar imaging at different time points (10 min, 1 h, 2 h and 3 h after injection) to obtain radiation dosimetry data. A calibration source of 37 MBq at injection time will be placed above the head of each patient to provide quantitative calibration of counts to activity.	2 years
The safety evaluation	Drug-related adverse reactions will be recorded during the 7-d follow-up period.	2 years

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Collaborators: NanoMab Technology (UK) Limited
• Investigators: Principal Investigator: Jinhua Zhao, PhD, Department of Nuclear Medicine, Shanghai General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: PET/CT; 68Ga-THP-PSMA
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: [2018]15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No