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

NCT04158817 | Completed Early Phase 1

• 1 other identifier: [2018]15
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

68Ga-THP-PSMA; PET/CT

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• The correlation analysis

  2 years

• The dosimetry assessment

  2 years

• The safety evaluation

  2 years

Study Arms (1)

Experimental Arm

EXPERIMENTAL

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; Drug: Non-labeled PSMA

Interventions

68Ga-Labeled PSMA DRUG

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.

Also known as: 68Ga-THP-PSMA

Experimental Arm

Non-labeled PSMA DRUG

Patient will be injected with microdose (\<100 ug) of THP-PSMA

Also known as: THP-PSMA

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 79 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects with pacemakers
• 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
• 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).
• Impaired renal function during screening: serum creatinine or urea nitrogen \> 1.5 times ULN.
• 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)
• Subjects with pulmonary embolism or deep vein thrombosis
• 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.
• Patients with abnormal thyroid function during baseline screening period (including but not limited to active hyperthyroidism, hypothyroidism or Hashimoto's thyroiditis)

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead
• NanoMab Technology (UK) Limited: collaborator

Study Sites (1)

Shanghai General Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jinhua Zhao, PhD

  Department of Nuclear Medicine, Shanghai General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Department of Nuclear Medicine, Principal Investigator, Professor

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: November 12, 2019
• Study Start: November 1, 2019
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CN (1)