Ignite Creation Date:
2024-05-06 @ 1:16 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03977610
Status:
COMPLETED
Last Update Posted:
2021-07-28
First Post:
2019-06-05
Brief Title:
The Role of Ga68-PSMA-11 PET Imaging in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
The Role of Ga68-PSMA-11 PET Imaging in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 PETCT 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 mlmin173 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
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 PETCT 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 mlmin173 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
Detailed Description:
It is a single-arm clinical trial The primary endpoint is diagnostic positivity rate of Ga68-PSMA-11 in metastasis lesion Sample size calculation is performed using two-sided one-proportion test to achieving an 82 power at the 5 level of significance The primary measurement of positivity can be obtained for the one-proportion test with statistical hypotheses H0 P P0 versus H1 PP0 We assume the alternative positivity rate is 659 and the null positivity rate is 439 which is the reference value from Maurer T et al J Urol 20161951436-1443 Thus the sample size needed is 43 According to the estimated missing rate 15 the sample size in this study is 51 The sample size calculation was performed using PASS software Power Analysis and Sample Size version 1108 NCSS Kaysville Utah USA All subjects enrolled must meet eligibility criteria based on the inclusionexclusion criteria detailed in Section 54 and 55
For PETCT PSMA scan the subject will have catheters placed for intravenous administration of 68GaPSMA-11 Subjects will receive a single intravenous bolus of 2-5 mCi 68GaPSMA-11 and received PETCT scan 60 minutes later The data acquisition begin with non-contrast CT at 120kVp automated mAs and a pitch of 15 followed by PET acquisition from the mid-thigh to skull-base 3 minutes each bed 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 scan no more than two weeks Patient will underwent two times of PSMA-11 PETCT scans before and under androgen deprivation therapy within a 10-14 weeks interval In the follow up period if metastatic castration-resistance status happens patient may underwent optional PSMA-11 PETCT scan by attendings discrimination in order to give appropriate treatment suggestions
Time elapsed from the last PSA determination until PET scan was no more than 6 weeks in all patients Patients will receive complementary workups All of the images were interpreted by a team of two nuclear medicine physicians and one radiologist In cases of questionable findings the decision was made by consensus of at least two observers using pre-specified criteria For patients with discrepancy image findings between each modality biopsy results may be taken into consideration to determine the final status
For PETCT PSMA scan the subject will have catheters placed for intravenous administration of 68GaPSMA-11 Subjects will receive a single intravenous bolus of 2-5 mCi 68GaPSMA-11 and received PETCT scan 60 minutes later The data acquisition begin with non-contrast CT at 120kVp automated mAs and a pitch of 15 followed by PET acquisition from the mid-thigh to skull-base 3 minutes each bed 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 scan no more than two weeks Patient will underwent two times of PSMA-11 PETCT scans before and under androgen deprivation therapy within a 10-14 weeks interval In the follow up period if metastatic castration-resistance status happens patient may underwent optional PSMA-11 PETCT scan by attendings discrimination in order to give appropriate treatment suggestions
Time elapsed from the last PSA determination until PET scan was no more than 6 weeks in all patients Patients will receive complementary workups All of the images were interpreted by a team of two nuclear medicine physicians and one radiologist In cases of questionable findings the decision was made by consensus of at least two observers using pre-specified criteria For patients with discrepancy image findings between each modality biopsy results may be taken into consideration to determine the final status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None