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

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ClinicalTrials.gov Identifier: NCT03207139
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Jing-Ren Tseng, Chang Gung Memorial Hospital

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 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

Condition or disease Intervention/treatment Phase
Latent Cancer Prostate Drug: Ga-68 PSMA ligand Phase 2

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 2×2 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 inclusion/exclusion criteria detailed in Section 5.4 and 5.5.

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 PET/CT 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 patient's clinical history, blood tests, and previous imaging findings. If patient have consistent findings between Ga68 PSMA ligand PET/CT and other complementary workups, the patients are deemed as true positive or negative. For patients with discrepancy image findings between Ga68 PSMA ligand PET/CT and the other complementary workups, biopsy, needle aspiration or operation will be arranged for histology confirmation. The final results of Ga68-PSMA ligand PET/CT scan will be depend on the consensus of multidisciplinary tumor board based on all integrated informations.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ga-68 PSMA Ligand: A Radiopharmaceutical for Localization of Prostate Cancer
Actual Study Start Date : June 22, 2017
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Ga-68 PSMA ligand
Diagnostic performance of [Ga68] PSMA-11
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.

Other Name: Ga-68 PSMA-11, PSMA-HBED-CC




Primary Outcome Measures :
  1. Ga-68 PSMA ligand : A radiopharmaceutical for localization of prostate cancer [ Time Frame: Three years ]
    To evaluate sensitivity of Ga68 PSMA ligand compared with a reference value of the standard



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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

Exclusion Criteria:

  1. Unable to tolerate the PET/CT scan, such as those with claustrophobia, unable to lie still.
  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, and high risk to conduct examination after evaluations of PI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207139


Locations
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Taiwan
Chang Gung Memorial Hospital ,Linkou
Taoyuan City, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Tseng Jing-Ren, MD Chang Gung Memorial Hospital
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Responsible Party: Jing-Ren Tseng, Nuclear Medicine, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03207139    
Other Study ID Numbers: 201600097A0
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jing-Ren Tseng, Chang Gung Memorial Hospital:
cancer prostate
Ga-68 PSMA Ligand
staging
biochemical failure
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases