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Update: FDA approves new imaging drug for detecting spread of prostate cancer

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At a glance What does this mean for me?
Gallium 68 PMSA-11 tracer Clinical trials
Research findings Guidelines
Side effects of Ga 68 PSMA-11 Questions to ask your provider
Risk associated with Ga 68 PMSA-11 Resources



This report is about:

approval of a new type of to detect the spread of cancer in men who are newly diagnosed with advanced disease and in those whose cancer has returned after treatment.

Why is this report important?

About seven percent of all cancer are diagnosed at advanced stages (they have spread beyond the ). The has granted approval to several imaging tests, including X-rays, magnetic resonance imaging () and computed tomography (), for detecting the spread of cancer and to help doctors determine the of the disease. However, all imaging techniques have limitations and can fail to detect small deposits of disease outside the (). 

On December 1, 2020, the approved a new imaging technique for detecting the spread of cancer throughout the body. The technique uses a Gallium 68 PSMA-11 tracer which is detected by positron emission tomography (PET) scanning. The tracer is injected through a vein and moves throughout the body to attach to its target protein (e.g a protein found in cancer cells). PET scanners can then locate where the tracer has accumulated at high levels throughout the body, there by detecting any spread of caner.  PET scans can be used together with other imaging tests, such as CT (PET/CT) and (PET/MRI).

Gallium 68 PMSA-11 tracer:

The recent approval was based on two studies that looked at a new radioactive tracer called Gallium 68 PSMA-11 (Ga 68 PSMA-11). 

When injected in the body, Ga 68 PSMA-11 attaches to a protein called (PSMA). Although PSMA is found at low levels in normal cells, it is found at high levels in cancer cells. Over the past decade, more research has focused on radioactive tracers that bind to to locate spread of cancer to other regions of the body. Accurately detecting cancer spread can help doctors cancer and develop treatment plans.

Research findings:

In the two multi-site studies that led to approval, Ga 68 PSMA-11 was observed in two groups of men:

  • men with newly diagnosed advanced cancer  
  • men whose cancer returned after treatment

Study #1

This first study included 325 men with newly diagnosed cancer who underwent imaging with Ga 68 PSMA-11 using PET/CT or PET/MRI scans.

All patients were considered at high-risk for advanced () cancer and were candidates for surgical removal of the gland and nearby pelvic . Results showed that:

  • among men who opted for surgical removal procedures, Ga 68 PSMA-11 was able to detect the spread of cancer to nearby pelvic . These results were confirmed by surgically removing the and then testing them for the presence of cancer cells.

Study #2

The second study included 635 men whose blood test suggested return of cancer after treatment with radiation therapy or removal.

All of these men underwent imaging with Ga 68 PSMA-11 using PET/CT or PET/MRI scans. Based on results of scans:

  • Ga 68 PSMA-11 detected the spread of cancer to at least one body region outside the gland in 74 percent of patients.
    • These regions included bone, pelvic and the soft tissue of the pelvis.
    • The spread of cancer detected by Ga 68 PSMA-11 was confirmed by additional tests, such as blood analysis, tissue sampling of affected organs and bone scan.

Side effects of Ga 68 PSMA-11

The most common side effects related to Ga 68 PSMA-11 tracer included:

  • nausea
  • diarrhea
  • dizziness

Risks associated with Ga 68 PMSA-11

The noted a possible risk for misdiagnosis of prostate cancer by Ga 68 PMSA-11. The tracer may bind to other types of cancer or certain nonmalignant regions, which may lead to errors.

In addition, because Ga 68 PSMA-11 is a radioactive agent, it contributes to a patient’s overall long-term radiation exposure, which could increase the risk for cancer. However, the risk of developing cancer due to the low radiation exposure by an imaging test is very unlikely, according to the American Cancer Society (“Understanding Radiation Risk from Imaging Tests”).

What does this mean for me?

If you are newly diagnosed with cancer that your doctor suspects has spread to other organs or you have completed treatment and your doctor suspects your cancer has spread, you may want to talk to your doctor if Ga 68 PSMA-11 PET testing could benefit you.

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Posted 1/7/21


Fendler W, Calais J, Eiber M, et al. Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Cancer: A Single-Arm Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):856-863.

Approves First PSMA-Targeted PET Imaging Drug for Men with Cancer. Website, December 1, 2020.


FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board before publication to assure scientific integrity.

This article is relevant for:

Men with prostate cancer

This article is also relevant for:

people with prostate cancer

people newly diagnosed with cancer

people with metastatic or advanced cancer

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Questions To Ask Your Doctor
Questions To Ask Your Doctor

  • What tests have already been done to detect spread of my cancer?
  • Is Ga 68 PMSA-11 an option for detecting spread of my cancer? How often should I have it done?
  • If Ga 68 PMSA-11 is not an option for me now, might it be an option in the future?
  • What side effects might I experience with Ga 68 PMSA-11?
  • Are any other agents or procedures available to detect the spread of my cancer?  

Open Clinical Trials
Open Clinical Trials

The following are studies looking at new methods for , monitoring and finding recurrence in people with cancer.  

A number of other clinical trials for monitoring patients with cancer can be found here.

Updated: 05/29/2023

Peer Support
Peer Support

The following organizations offer peer support services for people with or at high risk for cancer:

Updated: 03/08/2023

Who covered this study?

New York Times

New scan finds prostate cancer cells hiding in the body This article rates 4.0 out of 5 stars

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