MedTrace Logo

The Role of Ga68-PSMA-11 PET Imaging in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy

NCT03977610 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-07-28

No results posted yet for this study

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 PET/CT 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 ml/min/1.73 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

Conditions

Interventions

DRUG

Ga-68 PSMA ligand

For PSMA PET/CT 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. Patient will underwent two times of PSMA-11 PET/CT scans before and under androgen deprivation therapy within a 10-14 weeks interval.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Jing-Ren Tseng, MD · Chang Gung Memorial Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2021-07-27
Completion
2021-07-27

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03977610 on ClinicalTrials.gov