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68Ga-PSMA PET/CT for Ra223 Assessment

StatusUnknown
PhaseNot applicable
Started2022-03-02
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 29, 2025 (before its estimated August 31, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
Trial status changed: Recruiting → Unknown
2025-08-24
Study Status, Oversight, IPDSharing v7
Trial statusRecruiting→Unknown
Primary completion date2025-07-31→2025-08-31
Completion date2025-07-31→2025-08-31
2024-08-21
Study Status v6
Primary completion date2024-07-31→2025-07-31
Completion date2024-12-31→2025-07-31
2022-03-01
Study Status v5
Start dateestimated 2022-01-01→confirmed 2022-03-02
2022-01-04
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
Show 3 earlier versions
2021-08-23
Study Status, Eligibility v3
Eligibility criteria-1 characters
[...] han 1000/uL) or thrombocytopenia (platelet counts less than 500x10350x103/uL) lasting > 14 days
2021-08-16
Study Identification, Study Status, Outcome Measures, Eligibility v2
Primary completion date2023-07-31→2024-07-31
Completion date2023-07-31→2024-12-31
Start date2021-08-01→2022-01-01
Eligibility criteria+156 characters
Inclusion Criteria: Males with 40-85 years of age and life expectancy more than 3 months Patient was diagnosed as mCRPC, and meet the standard crite [...] eral organ metastasis) Willing to sign the informed consent ECOG performance status Grade 0-2 Exclusion Criteria: Unable to tolerate the PET/CT scan, such [...] t examination after evaluations of PI. Patient had previous other malignancy history Patient experiences grade 3-4 neutropenia (neutrophil counts less than 1000/uL) or thrombocytopenia (platelet counts less than 500x103/uL) lasting > 14 days
Study title-85 characters
Using 68Ga-PSMA PET/CT for theRa223 Assessment of Osseous Tumor Burden in mCRPC Patients Undergoing 223Ra-dichloride Injections
2021-07-06
Study Status, Sponsor/Collaborators, Study Description v1
Study description+1,467 characters
1It is a open-label single-arm clinical trial.Main Outcome inclusionmeasurement criteria:is the positivity rate of Ga68-PSMA-11 PET-defined progression and Bone Scan-defined progression. ToThe primary objective is to compare the diagnostic positivity in progression of PSMA PET and BS. The 2×2 contingency table with four diagnostic outcomes (both positive, PET positive/BS negative, PET negative/BS positive, and both negative) will be eligibleconducted based on the enrolled subjects. Both diagnostic tools (Ga68-PSMA-11 PET and BS) are applied to a given set of individuals. Since both diagnostic [...] [...]
2021-06-30
Original filing
Primary objective: i.The primary objective is to compare the diagnostic positivity in progression of 68Ga-PSMA PET and Bone scan. Secondary objectives: i.The correlation between PET osseous tumor burden index and Alk-P level ii.The correlation between PET osseous tumor burden index and PSA level
Trial Details
NCT Number NCT04951817
Lead Sponsor Chang Gung Memorial Hospital
Conditions Metastatic Prostate Cancer
Enrollment 52 participants
Start Date 2022-03-02
Primary Completion 2025-08-31 (estimated)
Study Completion 2025-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-29