An interventional study of Ga-68 PSMA ligand in Metastatic Prostate Cancer, sponsored by Chang Gung Memorial Hospital. Recruiting at 1 site in Taiwan. Open to male participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-08-29.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Diagnostic
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
It is a open-label single-arm clinical trial. Outcome measurement is the positivity rate of Ga68-PSMA-11 PET-defined progression and Bone Scan-defined progression. The 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 conducted 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 tools will performed on each subject, then paired data result and methods that account for the correlated binary outcomes are necessary. McNemar's test will be used to compare the positivity of the two tools. Assuming that Ga68-PSMA-11 PET in patients detect more metastatic lesions/progression by 26.5% (i.e. p10-p01=0.265) and the discordant percentage is 38.5 % (i.e. p10+p01=0.385). Under the hypothesis H0: p10=p01, achieving an 80% power at the 5% of significance level, the sample size is 44. Based on expecting 15% of missing rate, the adjusted sample size will be 52. This calculation was done by PASS software (Power Analysis and Sample Size version 11.0.8, NCSS, Kaysville, Utah, USA).
For PET/CT PSMA scan, the subject will have catheter(s) placed for intravenous administration of [68Ga]PSMA-11. Subjects will receive a single intravenous bolus of 2-5 mCi [68Ga]PSMA-11 and received PET/CT scan 60 minutes later. PSMA PET-CT scan was performed on a GE Discovery MI PET/CT system. The CT scan parameters were 120 kVp, 30 mA to 300 mA acquired with auto mA , 40× 0.625 collimator configuration, and pitch of 0.984 : 1. All images were reconstructed with a 500 mm field of view and a slice thickness of 5 mm. The PET acquisition time was 3 mins per bed position with maximum overlap (35 slices). Images were reconstructed using Q clear with beta value of 550, PSF correction, and non-TOF (QCHD-S). The matrix is 256 × 256. After image acquisition, the subject will be observed for half an hour, and will be discharged if no adverse event happens. EKG, blood and biochemistry test will be performed before and after first PET scan no more than two weeks. Except baseline Ga68-PSMA-11 PET/CT scan, patients will receive serial PET scans after 3rd injection of Ra-233 and 6th injection of Ra-223. All of the images were interpreted by an experienced nuclear medicine physicians.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 52 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
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Exclusion Criteria:
Glass vial with 5\~20 mCi(185-740 MBq) of 68Ga-PSMA ligand in ≤10% EtOH with aqueous sterile water for injection solution (approximately 15.5 mL), ≧ 0.33 mCi/mL @ EOS。
Drug: Ga-68 PSMA ligand
For PET/CT PSMA scan, the subject will have catheter(s) placed for intravenous administration of \[68Ga\]PSMA-11. Subjects will receive a single intravenous bolus of 2-5 mCi \[68Ga\]PSMA-11 and received PET/CT scan 60 minutes later.PSMA PET-CT scan was performed on a GE Discovery MI PET/CT system.
Also known as: Ga68-PSMA-11 (Gallium-68 labeled HBED-CC PSMA)
Change of lesion detection number by PET imaging
Lesion detection number before and under Ra223 therapy on the PSMA PET imaging with a time interval 9-11 weeks and/or 21-23 weeks
Time frame: 9-11 weeks or 21-23 weeks
Plan to share: No
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Chang Gung Memorial Hospital