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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04158817
• Other study ID #: [2018]15
• Status: Completed
• Phase: Early Phase 1
• Start date: November 1, 2019
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2023
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• Non-labeled PSMA
Patient will be injected with microdose (<100 ug) of THP-PSMA

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	NanoMab Technology (UK) Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximal standard uptake value	The tumor SUVmax of patients will be measured using Region Of Interest.	2 years
Primary	The measurement of PSA	The PSA level (ng/mL) of patients will be tested by hemanalysis	2 years
Primary	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	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
Secondary	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
Secondary	The safety evaluation	Drug-related adverse reactions will be recorded during the 7-d follow-up period.	2 years