NCT05034562

Brief Summary

This phase II trial studies how well gallium-68 PSMA-11 PET/CT or PET/MRI works in finding prostate cancer cells that have come back (recurrent) in patients with prostate cancer. Gallium-68 PSMA-11 is a type of radioactive compound, called a radiotracer, which is injected in the vein and can accumulate in tumor cells to generate a signal detected by PET/CT or PET/MRI imaging. This may help researchers in finding recurrent prostate cancer cells in patients with prostate cancer.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2022

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2020

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 26, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2022

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

Same day

First QC Date

June 10, 2020

Last Update Submit

March 5, 2024

Conditions

Metastatic Prostate CarcinomaRecurrent Prostate CarcinomaStage IV Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8Stage IVB Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

  • Positive predictive value of 68Ga-PSMA-11 (gallium Ga 68-labeled PSMA-11) positron emission tomography (PET)

    Positive predictive value will be defined as true positive/(true positive + false positive). Positive predictive value on a per-participant and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up will be calculated and reported along with the corresponding two-sided 95% confidence intervals.

    Up to 36 months

Study Arms (1)

Diagnostic (gallium Ga 68-labeled PSMA-11, PET/CT, PET/MRI)

EXPERIMENTAL

Patients receive gallium Ga 68-labeled PSMA-11 IV. 50-100 minutes after injection, patients then undergo a PET/CT scan or PET/MRI scan over 60 minutes.

Procedure: Computed TomographyDrug: Gallium Ga 68-labeled PSMA-11Procedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography

Interventions

Computed TomographyPROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Diagnostic (gallium Ga 68-labeled PSMA-11, PET/CT, PET/MRI)
Gallium Ga 68-labeled PSMA-11DRUG

Given IV

Also known as: (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68Ga)Glu-urea-Lys(Ahx)-HBED-CC, 68Ga-DKFZ-PSMA-11, 68Ga-HBED-CC-PSMA, 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, 68Ga-PSMA, 68Ga-PSMA-11, 68Ga-PSMA-HBED-CC, [68Ga] Prostate-specific Membrane Antigen 11, [68Ga]GaPSMA-11, Ga PSMA, Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled PSMA-11, Gallium Ga 68 PSMA-11, Gallium-68 PSMA, Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, GaPSMA, PSMA-HBED-CC GA-68
Diagnostic (gallium Ga 68-labeled PSMA-11, PET/CT, PET/MRI)
Magnetic Resonance ImagingPROCEDURE

Undergo PET/MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Diagnostic (gallium Ga 68-labeled PSMA-11, PET/CT, PET/MRI)
Positron Emission TomographyPROCEDURE

Undergo PET/CT or PET/MRI

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Diagnostic (gallium Ga 68-labeled PSMA-11, PET/CT, PET/MRI)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically proven prostate cancer
  • Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)
  • Karnofsky performance status (KPS) \>= 50 (Eastern Cooperative Oncology Group \[ECOG\]/World Health Organization \[WHO\] 0, 1, or 2)
  • Ability to understand and willingness to provide informed consent
  • Participants with known metastatic prostate cancer planned to undergo active systemic treatment

You may not qualify if:

  • Unable to lie flat, still, or tolerate a PET or MRI scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-1168Ga-DKFZ-PSMA-11Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Gregory C Ravizzini, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2020

First Posted

September 5, 2021

Study Start

September 26, 2022

Primary Completion

September 26, 2022

Study Completion

September 26, 2022

Last Updated

March 7, 2024

Record last verified: 2024-03