Ignite Creation Date:
2024-05-06 @ 10:15 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03207139
Status:
COMPLETED
Last Update Posted:
2019-07-17
First Post:
2017-06-29
Brief Title:
Ga-68 PSMA Ligand A Radiopharmaceutical for Localization of Prostate Cancer
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Ga-68 PSMA Ligand A Radiopharmaceutical for Localization of Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2019-07
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 62 evaluable subjects According to the estimated missing rate 15 the sample size in this study is 73
Inclusion criteria
To be eligible for inclusion each patient must fulfill all of the following criteria
1 Age equals or more than 20 years old
2 Willing to sign the informed consent
3 Pathology-proved intermediate to high risk group prostate cancer patients PSA 10 ngmL or Gleason score 7-10 or clinical stage T2a OR Prior radiotherapy or prostatectomy for prostate cancer with biochemical recurrence defined as
post prostatectomy increase in PSA of 02 ngmL in two or more consecutive blood samples
post radiotherapy PSA levels of 2 ngmL above the post-therapy nadir
4 Life expectancy more than 3 months
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 Unable to give informed consent
4 Allergy history to Ga68-PSMA ligand significant abnormal lab data ALT more than three times of normal value and high risk to conduct examination after evaluations of PI
5 Patient had malignancy history
Inclusion criteria
To be eligible for inclusion each patient must fulfill all of the following criteria
1 Age equals or more than 20 years old
2 Willing to sign the informed consent
3 Pathology-proved intermediate to high risk group prostate cancer patients PSA 10 ngmL or Gleason score 7-10 or clinical stage T2a OR Prior radiotherapy or prostatectomy for prostate cancer with biochemical recurrence defined as
post prostatectomy increase in PSA of 02 ngmL in two or more consecutive blood samples
post radiotherapy PSA levels of 2 ngmL above the post-therapy nadir
4 Life expectancy more than 3 months
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 Unable to give informed consent
4 Allergy history to Ga68-PSMA ligand significant abnormal lab data ALT more than three times of normal value and high risk to conduct examination after evaluations of PI
5 Patient had malignancy history
Detailed Description:
It is a phase II single-arm clinical trial The primary endpoint is diagnostic sensitivity of the Ga-68 PSMA ligand in prostate cancer The four outcomes true positive false positive true negative and false negative can be defined based on the process as Figure 1 and formulated in a 22 contingency table and the related sensitivity specificity and accuracy will be calculated based on the test results of enrolled subjects All subjects enrolled must meet eligibility criteria based on the inclusionexclusion criteria detailed in Section 54 and 55
Time elapsed from the last PSA determination until PET was no more than 2 weeks in all patients Patients will receive complementary workups including MRI for patients suspicious for local or regional node recurrence bone scan for patients suspicious for distant bone metastasis contrast CT for patients suspicious for visceral organ metastasis or lung metastasis subsequently after Ga68-PSMA ligand PETCT scan no longer than two weeks
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 All of the readers were blinded to the patients clinical history blood tests and previous imaging findings If patient have consistent findings between Ga68 PSMA ligand PETCT and other complementary workups the patients are deemed as true positive or negative For patients with discrepancy image findings between Ga68 PSMA ligand PETCT and the other complementary workups biopsy needle aspiration or operation will be arranged for histology confirmation The final results of Ga68-PSMA ligand PETCT scan will be depend on the consensus of multidisciplinary tumor board based on all integrated informations
Time elapsed from the last PSA determination until PET was no more than 2 weeks in all patients Patients will receive complementary workups including MRI for patients suspicious for local or regional node recurrence bone scan for patients suspicious for distant bone metastasis contrast CT for patients suspicious for visceral organ metastasis or lung metastasis subsequently after Ga68-PSMA ligand PETCT scan no longer than two weeks
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 All of the readers were blinded to the patients clinical history blood tests and previous imaging findings If patient have consistent findings between Ga68 PSMA ligand PETCT and other complementary workups the patients are deemed as true positive or negative For patients with discrepancy image findings between Ga68 PSMA ligand PETCT and the other complementary workups biopsy needle aspiration or operation will be arranged for histology confirmation The final results of Ga68-PSMA ligand PETCT scan will be depend on the consensus of multidisciplinary tumor board based on all integrated informations
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