Clinical trial NCT04158817: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
Keywords: 68Ga-THP-PSMA
PET/CT
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: NanoMab Technology (UK) Limited
First posted: 2019-11-12
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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)

Primary outcomes:
measure: The maximal standard uptake value
timeFrame: 2 years
measure: The measurement of PSA
timeFrame: 2 years
measure: 68Ga-THP-PSMA PET/CT in prostate cancer: clinical stage and restage
timeFrame: 2 years
Secondary outcomes:
measure: The correlation analysis
timeFrame: 2 years
measure: The dosimetry assessment
timeFrame: 2 years
measure: The safety evaluation
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
Study officials:
affiliation: Department of Nuclear Medicine, Shanghai General Hospital
name: Jinhua Zhao, PhD
role: PRINCIPAL_INVESTIGATOR
References: