Clinical trial · Interventional
The Role of Ga68-PSMA-11 PET Imaging in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
- 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)
This is an open-label single arm clinical trial, Plan to enroll approximately a total of 43 evaluable subjects. According to the estimated missing rate 15%, the sample size in this study is 51. Inclusion criteria: To be eligible for inclusion, each patient must fulfill all of the following criteria: 1. Males with 40-85 years of age and life expectancy more than 3 months 2. Pathology-proved prostate cancer patients and classified as clinical stage III or IV (including lymph node or bone metastasis) 3. Willing to sign the informed consent Exclusion criteria: Patient who has any of the following criteria will be excluded from the trial: 1. Unable to tolerate the PET/CT scan, such as those with claustrophobia, unable to lie still, consciousness unclear, vital sign unstable. 2. With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast. 3. Significant abnormal lab data (AST or ALT more than three times of normal value), and high risk to conduct examination after evaluations of PI. 4. Patient had previous malignancy history 5. Patient had known allergy history or is probably allergy to Ga68-PSMA-11
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 |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ga-68 PSMA ligand | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ga68-PSMA ligand
- description
- Glass vial with 4\~20 mCi(148-740 MBq) of 68Ga-PSMA ligand in ≤10% EtOH with aqueous sterile water for injection solution (approximately 15.5 mL), more than 0.33 mCi/mL @ EOS; One time dose of 2-5 mCi (74-185 MBq) for PET Imaging ; i.v. injection
- interventionNames
- Drug: Ga-68 PSMA ligand
Primary outcomes (1)
- measure
- Change of lesion detection number by PET imaging
- timeFrame
- 10-14 weeks
- description
- Lesion detection number before and under androgen deprivation therapy on the PSMA PET imaging with a time interval 10-14 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Males with 40-85 years of age and life expectancy more than 3 months 2. Pathology-proved prostate cancer patients and classified as clinical stage III or IV (including lymph node or bone metastasis) 3. Willing to sign the informed consent Exclusion Criteria: 1. Unable to tolerate the PET/CT scan, such as those with claustrophobia, unable to lie still, consciousness unclear, vital sign unstable. 2. With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast. 3. Significant abnormal lab data (AST or ALT more than three times of normal value), and high risk to conduct examination after evaluations of PI. 4. Patient had previous malignancy history 5. Patient had known allergy history or is probably allergy to Ga68-PSMA-11
References
Publications (0)
Data not yet available