NCT04800068

Brief Summary

In this expanded access IND study, Mayo Clinic in Rochester MN offers \[Ga-68\] PSMA-11 PET/CT or PET/MR imaging to patients who meet criteria.

Trial Health

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Monitor

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

March 12, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

First QC Date

March 12, 2021

Last Update Submit

January 5, 2022

Conditions

Prostate Cancer

Interventions

[Ga-68] PSMA-11 PET/CTDIAGNOSTIC_TEST

Imaging scan

[Ga-68] PSMA-11 PET/MRDIAGNOSTIC_TEST

Imaging scan

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Serum prostate-specific antigen (PSA) concentration of 20 ng/mL or more
  • Pathologic criteria of International Society of Uropathology (ISUP) grade group 3-5 (ISUP grades 3-5 are equivalent to pathologic Gleason scores of 4+3, 8, 9 or 10)
  • Local staging of T3 or worse (Indicating that cancer has invaded into tissues outside of the prostate gland, as seen at either CT or MRI)
  • Biochemically Recurrent prostate cancer group (must meet one of the criteria):
  • In patients who have undergone a prostatectomy, PSA \> 0.2 ng/ml on 2 consecutive tests
  • In patients who have undergone definitive prostate radiation, PSA rise ≥ 2 ng/mL above the nadir PSA

You may not qualify if:

  • Patients unable to sign informed consent
  • Patient with a life expectancy less than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 12, 2021

First Posted

March 16, 2021

Last Updated

January 21, 2022

Record last verified: 2022-01

Locations

US(1)