Back to results

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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

68Ga-Labeled PSMA

Non-labeled PSMA

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring 68Ga-THP-PSMA, PET/CT

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

Shanghai General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Arm

Arm 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.

Outcomes

Primary Outcome Measures

The maximal standard uptake value

The tumor SUVmax of patients will be measured using Region Of Interest.

The measurement of PSA

The PSA level (ng/mL) of patients will be tested by hemanalysis

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.

Secondary Outcome Measures

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.

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.

The safety evaluation

Drug-related adverse reactions will be recorded during the 7-d follow-up period.

Full Information

NCT ID

NCT04158817

First Posted

October 22, 2019

Last Updated

April 13, 2023

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

NanoMab Technology (UK) Limited

1. Study Identification

Unique Protocol Identification Number

NCT04158817

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

March 31, 2023 (Actual)

Study Completion Date

March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

NanoMab Technology (UK) Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

68Ga-THP-PSMA, PET/CT

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Arm

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

68Ga-Labeled PSMA

Other Intervention Name(s)

68Ga-THP-PSMA

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Non-labeled PSMA

Other Intervention Name(s)

THP-PSMA

Intervention Description

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

Primary Outcome Measure Information:

Title

The maximal standard uptake value

Description

The tumor SUVmax of patients will be measured using Region Of Interest.

Time Frame

2 years

Title

The measurement of PSA

Description

The PSA level (ng/mL) of patients will be tested by hemanalysis

Time Frame

2 years

Title

68Ga-THP-PSMA PET/CT in prostate cancer: clinical stage and restage

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

The correlation analysis

Description

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.

Time Frame

2 years

Title

The dosimetry assessment

Description

Time Frame

2 years

Title

The safety evaluation

Description

Drug-related adverse reactions will be recorded during the 7-d follow-up period.

Time Frame

2 years

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jinhua Zhao, PhD

Organizational Affiliation

Department of Nuclear Medicine, Shanghai General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai General Hospital

City

Shanghai

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs