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

NCT03207139 | Completed Phase 2 DMC

• 1 other identifier: 201600097A0
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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:

• 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
• Life expectancy more than 3 months
• Unable to tolerate the PET/CT scan, such as those with claustrophobia, unable to lie still, consciousness unclear, vital sign unstable.
• With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast
• Unable to give informed consent.
• 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.
• Patient had malignancy history

Conditions

Latent Cancer Prostate

Keywords

cancer prostate; Ga-68 PSMA Ligand; staging; biochemical failure

Outcome Measures

Primary Outcomes (1)

• Ga-68 PSMA ligand : A radiopharmaceutical for localization of prostate cancer

  To evaluate sensitivity of Ga68 PSMA ligand compared with a reference value of the standard

  Three years

Study Arms (1)

Ga-68 PSMA ligand

EXPERIMENTAL

Diagnostic performance of \[Ga68\] PSMA-11

Drug: Ga-68 PSMA ligand

Interventions

Ga-68 PSMA ligand DRUG

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.

Also known as: Ga-68 PSMA-11, PSMA-HBED-CC

Ga-68 PSMA ligand

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age equals or more than 20 years old
• Willing to sign the informed consent
• 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

You may not qualify if:

• Unable to tolerate the PET/CT scan, such as those with claustrophobia, unable to lie still.
• With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast
• Unable to give informed consent.
• Allergy history to Ga68-PSMA ligand, significant abnormal lab data, and high risk to conduct examination after evaluations of PI.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital ,Linkou

Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Tseng Jing-Ren, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nuclear Medicine

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 2, 2017
• Study Start: June 22, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 17, 2019

Record last verified: 2019-07

Locations

TW (1)