Prostate CancerNCT04377152
Expanded Access 68Gallium-PSMA-11 PET for Prostate Cancer
A study testing 68Gallium-PSMA-11 and Positron Emission Tomography (PET) in people with Prostate Cancer and Prostate, run by University of California, San Francisco at 1 site in United States.
Trial summary
This expanded access protocol provides eligible participants with investigational 68Ga-PSMA-11 PET imaging to detect and localize prostate cancer for initial and subsequent treatment strategy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate, Prostate Adenocarcinoma
- What is being tested?
- 68Gallium-PSMA-11 and Positron Emission Tomography (PET)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Expanded Access: 68Gallium-PSMA-11 for PET Imaging of Prostate Cancer
This expanded access protocol provides eligible participants with investigational 68Ga-PSMA-11 PET imaging to detect and localize prostate cancer for initial and subsequent treatment strategy.
- Conditions
- Prostate Cancer, Prostate, Prostate Adenocarcinoma
- Being tested
- 68Gallium-PSMA-11, Positron Emission Tomography (PET)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Gallium-PSMA-11Drug
Also called PSMA-HBED-CC
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).
Positron Emission Tomography (PET)Procedure or surgery
Also called PET, PET Scan
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Hope, University of California, San Francisco
- Investigators
- Thomas Hope, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377152
- Sponsor's protocol ID
- EA-HOPE20200129
- Other IDs
- 20-30046
- Status last verified
- Feb 2021
- First submitted
- 1 May 2020
- Last updated
- 1 Mar 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access: 68Gallium-PSMA-11 for PET Imaging of Prostate Cancer
- ClinicalTrials.gov ID
- NCT04377152
- Acronym / sponsor ID
- EA-HOPE20200129
- Conditions
- Prostate Cancer, Prostate, Prostate Adenocarcinoma
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This expanded access protocol provides eligible participants with investigational 68Ga-PSMA-11 PET imaging to detect and localize prostate cancer for initial and subsequent treatment strategy.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Histopathologically confirmed or biopsy proven prostate adenocarcinoma.
- Concern for metastatic disease in one of the following settings:
- Ability to understand a written informed consent document, and the willingness to sign it
Key exclusion criteria (1 listed)
- 1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Gallium-PSMA-11Also: PSMA-HBED-CCPSMA-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). | Drug | – |
| Positron Emission Tomography (PET)Also: PET, PET ScanA 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 | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Hope, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Gallium-PSMA-11 and Positron Emission Tomography (PET) in people with Prostate Cancer and Prostate, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.