Clinical trial · Interventional
68Ga-THP-PSMA PET/CT in Prostate Cancer: Clinical Stage and Restage
Gallium-68 Labelled THP-PSMA for the Clinical Stage and Restage of Prostate Cancer Patients
NCT04158817CI-TRIAL-00065762completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-Labeled PSMA | Drug | — | UNRESOLVED |
| Non-labeled PSMA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Drug: 68Ga-Labeled PSMA
- Drug: Non-labeled PSMA
Primary outcomes (3)
- measure
- The maximal standard uptake value
- timeFrame
- 2 years
- description
- The tumor SUVmax of patients will be measured using Region Of Interest.
- measure
- The measurement of PSA
- timeFrame
- 2 years
- description
- The PSA level (ng/mL) of patients will be tested by hemanalysis
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.