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Completed

NCT Number: NCT04158817

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

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.

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Key information

Age range

18 year–79 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Shanghai General Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: 68Ga-THP-PSMA

Non-labeled PSMA

Drug

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

Other names: THP-PSMA

Primary outcomes

  1. The maximal standard uptake value

    Time frame: 2 years

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

  2. The measurement of PSA

    Time frame: 2 years

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

  3. 68Ga-THP-PSMA PET/CT in prostate cancer: clinical stage and restage

    Time frame: 2 years

    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 outcomes

  1. The correlation analysis

    Time frame: 2 years

    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. The dosimetry assessment

    Time frame: 2 years

    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.

  3. The safety evaluation

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • NanoMab Technology (UK) Limited

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 12, 2019
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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