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68Ga-PSMA for Prostate Cancer

Phase 2
Waitlist Available
Led By Morand R Piert, M.D.
Research Sponsored by University of Michigan
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 12 months post scan
Awards & highlights

Study Summary

This trial is testing a new radioactive molecule, 68Ga-PSMA, to see if it can help detect prostate cancer recurrence. participants will receive an injection of the molecule and then have a PET/CT scan. The scan results will be made available to participants and their treating physicians.

Eligible Conditions
  • Prostate Cancer
  • Prostate Adenocarcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post scan
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post 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
Positive Predictive Value (PPV) of 68Ga PSMA PET/CT for Detecting Prostate Cancer on a Per-patient Basis Confirmed by Histopathology.
Secondary outcome measures
Adverse Events of 68Ga-PSMA Administration
Detection Rates on a Per-patient Basis of 68Ga-PSMA-11 PET/CT
Impact of 68Ga-PSMA-11 PET on Clinical Management in BCR Patients
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patient participantsExperimental Treatment1 Intervention
PET/CT imaging
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
68Ga-PSMA
2018
Completed Phase 2
~1580

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,794 Previous Clinical Trials
6,372,481 Total Patients Enrolled
17 Trials studying Prostate Cancer
9,348 Patients Enrolled for Prostate Cancer
Morand R Piert, M.D.Principal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
11 Total Patients Enrolled
1 Trials studying Prostate Cancer
11 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.
Recent research and studies
Journal of Nuclear MedicineJournal
Evaluation of Hybrid <sup>68</sup>ga-psma Ligand PET/CT in 248 Patients with Biochemical Recurrence After Radical Prostatectomy
Eiber, Matthias, Tobias Maurer, Michael Souvatzoglou, Ambros J. Beer, Alexander Ruffani, Bernhard Haller, Frank-Philipp Graner, et al.. 2015. “Evaluation of Hybrid 68ga-psma Ligand PET/CT in 248 Patients with Biochemical Recurrence After Radical Prostatectomy”. Journal of Nuclear Medicine. Society of Nuclear Medicine. doi:10.2967/jnumed.115.154153.
Journal of UrologyJournal
Diagnostic Efficacy of <sup>68</sup> Gallium-psma Positron Emission Tomography Compared to Conventional Imaging for Lymph Node Staging of 130 Consecutive Patients with Intermediate to High Risk Prostate Cancer
Maurer, Tobias, Jürgen E. Gschwend, Isabel Rauscher, Michael Souvatzoglou, Bernhard Haller, Gregor Weirich, Hans-Jürgen Wester, et al.. 2016. “Diagnostic Efficacy of 68 Gallium-psma Positron Emission Tomography Compared to Conventional Imaging for Lymph Node Staging of 130 Consecutive Patients with Intermediate to High Risk Prostate Cancer”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2015.12.025.
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.
clinicaltrials.govStudy
Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
Morand Piert, MD 2018. "Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03396874.
~200 spots leftby Apr 2025
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