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Ga-68 PSMA-HBED-CC PET for Prostate Cancer

Phase 2 & 3

Waitlist Available

Research Sponsored by Michael Graham PhD, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 and 12 months after 68ga psma pet scan

Awards & highlights

Study Summary

This trial is investigating a new drug, PSMA, to see if it makes prostate cancer easier to identify in PET imaging. If successful, this could help match treatments to the location of the disease.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months after 68ga psma pet scan

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months after 68ga psma pet scan

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months after 68ga psma pet scan for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine sensitivity on a per-subject basis of 68Ga PSMA PET scans for detection of tumor location

Secondary outcome measures

Determine positive predictive value on a per-subject and per-region basis of 68Ga PSMA PET scans for detection of tumor location

Evaluate adverse events of 68Ga PSMA PET scan

Side effects data

From 2021 Phase 2 & 3 trial • 22 Patients • NCT03388346

Surgical and medical procedures - Other, specify

100%

80%

60%

40%

20%

Study treatment Arm

68Ga PSMA PET Scan

Trial Design

1Treatment groups

Experimental Treatment

Group I: 68Ga PSMA PET scanExperimental Treatment1 Intervention

Ga-68 PSMA-HBED-CC PET

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gallium-68 PSMA

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Michael Graham PhD, MDLead Sponsor

2 Previous Clinical Trials

262 Total Patients Enrolled

1 Trials studying Prostate Cancer

22 Patients Enrolled for Prostate Cancer

University of IowaOTHER

446 Previous Clinical Trials

879,462 Total Patients Enrolled

1 Trials studying Prostate Cancer

22 Patients Enrolled for Prostate Cancer

Holden Comprehensive Cancer CenterOTHER

26 Previous Clinical Trials

737 Total Patients Enrolled

1 Trials studying Prostate Cancer

22 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people currently being accepted into this research study?

"This particular clinical trial is not recruiting patients at this time. The study was first posted on February 16th, 2018 and updated as recently as May 21st, 2021. However, if you are seeking other studies, there are 4666 trials actively looking for prostatic cancer, castration-resistant participants and 8 Ga-68 PSMA-HBED-CC PET studies with open recruitment."

Answered by AI

Could you please elaborate on any other research done using Ga-68 PSMA-HBED-CC PET?

"There are a total of 8 ongoing clinical trials researching Ga-68 PSMA-HBED-CC PET. Of these, 2 have progressed to Phase 3 testing. Although the majority of research is being conducted in Iowa City, Iowa - there are 8 different locations running trials for this treatment."

Answered by AI

To date, how many people have enrolled in this clinical trial?

"This study has completed recruitment and is no longer looking for volunteers. The trial was posted on February 16th, 2018 and last updated on May 21st, 2021. However, there are 4666 studies related to prostatic cancer, castration-resistant and 8 trials specifically for Ga-68 PSMA-HBED-CC PET that are currently searching for participants."

Answered by AI

Recent research and studies

European Journal of Nuclear Medicine and Molecular ImagingJournal

The Diagnostic Value of PET/CT Imaging with the 68ga-labelled PSMA Ligand HBED-CC in the Diagnosis of Recurrent Prostate Cancer

Afshar-Oromieh, Ali, Eleni Avtzi, Frederik L. Giesel, Tim Holland-Letz, Heinz G. Linhart, Matthias Eder, Michael Eisenhut, et al.. 2014. “The Diagnostic Value of PET/CT Imaging with the 68ga-labelled PSMA Ligand HBED-CC in the Diagnosis of Recurrent Prostate Cancer”. European Journal of Nuclear Medicine and Molecular Imaging. Springer Science and Business Media LLC. doi:10.1007/s00259-014-2949-6.

Nuclear Medicine and BiologyJournal

Estimation of Radiation Dosimetry for 68ga-hbed-cc (PSMA-11) in Patients with Suspected Recurrence of Prostate Cancer

Green, Mark A., Jacob A. Eitel, James W. Fletcher, Carla J. Mathias, Mark A. Tann, Thomas Gardner, Michael O. Koch, Wendy Territo, Heather Polson, and Gary D. Hutchins. 2017. “Estimation of Radiation Dosimetry for 68ga-hbed-cc (PSMA-11) in Patients with Suspected Recurrence of Prostate Cancer”. Nuclear Medicine and Biology. Elsevier BV. doi:10.1016/j.nucmedbio.2016.11.002.

BJU InternationalJournal

Prospective Evaluation of 68gallium-prostate-specific Membrane Antigen Positron Emission Tomography/computed Tomography for Preoperative Lymph Node Staging in Prostate Cancer

van Leeuwen, Pim J., Louise Emmett, Bao Ho, Warick Delprado, Francis Ting, Quoc Nguyen, and Phillip D. Stricker. 2016. “Prospective Evaluation of 68gallium-prostate-specific Membrane Antigen Positron Emission Tomography/computed Tomography for Preoperative Lymph Node Staging in Prostate Cancer”. BJU International. Wiley. doi:10.1111/bju.13540.

Journal of UrologyJournal