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Ga-68 PSMA Ligand: A Radiopharmaceutical for Localization of Prostate Cancer

NCT03207139 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2019-07-17

No results posted yet for this study

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 ng/mL, 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 \> 0.2 ng/mL in two or more consecutive blood samples
* post radiotherapy: PSA levels of ≥ 2 ng/mL 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 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. 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

Conditions

  • Latent Cancer Prostate

Interventions

DRUG

Ga-68 PSMA ligand

For PET/CT PSMA ligand scan, the subject will have catheter(s) placed for intravenous administration of \[68Ga\]PSMA ligand . Subjects will receive a single intravenous bolus of 2-5 mCi \[68Ga\]PSMA ligand and received PET/CT scan 60 minutes later. The data acquisition begin with non-contrast CT at 120kVp, automated mAs, and a pitch of 1.5, 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. The estimated organ doses show that the kidneys and the urinary bladder wall were the organs with the highest dose. As presented, the effective doses for patients were 0.023 mSv/MBq ± 15% (maximum deviation), leading to an effective dose of 3.4 mSv for an injected activity of 150 MBq.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-22
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • Taiwan

Study Locations

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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 NCT03207139 on ClinicalTrials.gov