Expanded Access 68Gallium-PSMA-11 PET for Prostate Cancer


Study First Submitted Date 2020-05-01
Study First Posted Date 2020-05-07
Last Update Posted Date 2021-03-01
Verification Month Year February 2021
Verification Date 2021-02-28
Last Update Posted Date 2021-03-01


Sequence: 198416610
Name University of California, San Francisco
City San Francisco
State California
Zip 94143
Country United States


Sequence: 51730101 Sequence: 51730102 Sequence: 51730103
Name Prostate Cancer Name Prostate Name Prostate Adenocarcinoma
Downcase Name prostate cancer Downcase Name prostate Downcase Name prostate adenocarcinoma

Id Information

Sequence: 39807877 Sequence: 39807878
Id Source org_study_id Id Source secondary_id
Id Value EA-HOPE20200129 Id Value 20-30046
Id Type Other Identifier
Id Type Description University of California, San Francisco


Sequence: 42207025
Name United States
Removed False


Sequence: 52051792 Sequence: 52051793
Intervention Type Drug Intervention Type Procedure
Name 68Gallium-PSMA-11 Name Positron Emission Tomography (PET)
Description PSMA-11 Ga 68 Injection is a positron emitting radiopharmaceutical containing radioactive 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC (PSMA-11), which is used for diagnostic purposes in conjunction with Positron Emission Tomography (PET). Description A PET scan is an imaging test that helps reveal how your tissues and organs are functioning using a radioactive drug (tracer) to show this activity

Browse Conditions

Sequence: 191712273 Sequence: 191712274 Sequence: 191712275 Sequence: 191712276 Sequence: 191712277 Sequence: 191712278 Sequence: 191712279 Sequence: 191712280 Sequence: 191712281 Sequence: 191712282
Mesh Term Prostatic Neoplasms Mesh Term Genital Neoplasms, Male Mesh Term Urogenital Neoplasms Mesh Term Neoplasms by Site Mesh Term Neoplasms Mesh Term Genital Diseases, Male Mesh Term Genital Diseases Mesh Term Urogenital Diseases Mesh Term Prostatic Diseases Mesh Term Male Urogenital Diseases
Downcase Mesh Term prostatic neoplasms Downcase Mesh Term genital neoplasms, male Downcase Mesh Term urogenital neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term neoplasms Downcase Mesh Term genital diseases, male Downcase Mesh Term genital diseases Downcase Mesh Term urogenital diseases Downcase Mesh Term prostatic diseases Downcase Mesh Term male urogenital diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 47909688
Agency Class OTHER
Lead Or Collaborator lead
Name University of California, San Francisco

Overall Officials

Sequence: 29028567
Role Principal Investigator
Name Thomas Hope, MD
Affiliation University of California, San Francisco


Sequence: 30508238
Gender Male
Minimum Age 18 Years
Maximum Age N/A
Criteria Biochemical recurrent and pre-prostatectomy staging participants will be eligible and must meet the following criteria: Inclusion Criteria: Age ≥ 18 years Histopathologically confirmed or biopsy proven prostate adenocarcinoma. Concern for metastatic disease in one of the following settings: Initial staging with intermediate to high risk prostate cancer. Biochemical recurrence after initial therapy. Ability to understand a written informed consent document, and the willingness to sign it Exclusion Criteria: 1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254055813
Number Of Facilities 1
Registered In Calendar Year 2020
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years

Intervention Other Names

Sequence: 26458266 Sequence: 26458267 Sequence: 26458268
Intervention Id 52051792 Intervention Id 52051793 Intervention Id 52051793
Name PSMA-HBED-CC Name PET Name PET Scan

Responsible Parties

Sequence: 28637814
Responsible Party Type Principal Investigator
Name Thomas Hope
Title Principal Investigator
Affiliation University of California, San Francisco