Clinical Trials List
Protocol Number20210114
NCT Number(ClinicalTrials.gov Identfier)NCT04951817
2022-01-01 - 2024-12-31
Phase II
Recruiting1
ICD-10C61
Malignant neoplasm of prostate
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9185
Malignant neoplasm of prostate
Using 68Ga-PSMA PET/CT for the assessment of osseous tumor burden in mCRPC patients
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Trial Applicant
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Sponsor
Chang Gung Memorial Hospital
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Trial scale
Taiwan Single Center
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Update
2025/08/20
Investigators and Locations
Linkou Chang Gung Medical Foundation
Chairman/Global PI
曾敬仁
Co-Principal Investigator
- 張英勛 Division of Hematology & Oncology
- See-Tong Pang Division of Hematology & Oncology
- Feng-Yuan Liu Division of Nuclear Medicine
- Kai-Jie Yu Division of Hematology & Oncology
- 張思瀚 Division of Nuclear Medicine
- Tzu-Chen Yen Division of Nuclear Medicine
- Po-Jung Su Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Metastatic Prostate Cancer
Objectives
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.
Test Drug
Ga-68 PSMA ligand
Active Ingredient
Ga68-PSMA-11 (Gallium-68 labeled HBED-CC PSMA)
Dosage Form
I.V. injection
Dosage
One time dose of 2-5 mCi (74-185 MBq)
Endpoints
Change of lesion detection number by PET imaging [ Time Frame: 9-11 weeks or 21-23 weeks ]
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
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
Inclution Criteria
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 criteria of using 223Ra-dichloride (symptomatic bone metastasis, at least two bone metastasis sites, no visceral organ metastasis)
Willing to sign the informed consent
ECOG performance status Grade 0-2
Males with 40-85 years of age and life expectancy more than 3 months
Patient was diagnosed as mCRPC, and meet the standard criteria of using 223Ra-dichloride (symptomatic bone metastasis, at least two bone metastasis sites, no visceral organ metastasis)
Willing to sign the informed consent
ECOG performance status Grade 0-2
Exclusion Criteria
Exclusion Criteria:
Unable to tolerate the PET/CT scan, such as those with claustrophobia, unable to lie still, consciousness unclear, vital sign unstable.
With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast.
Significant abnormal lab data (AST or ALT more than three times of normal value), and high risk to conduct 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 50x103/uL) lasting > 14 days
Unable to tolerate the PET/CT scan, such as those with claustrophobia, unable to lie still, consciousness unclear, vital sign unstable.
With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast.
Significant abnormal lab data (AST or ALT more than three times of normal value), and high risk to conduct 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 50x103/uL) lasting > 14 days
The Estimated Number of Participants
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Taiwan
52 participants
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Global
0 participants
