Update: FDA approves new imaging drug for detecting spread of prostate cancer
On December 1, 2020 the FDA approved a new type of imaging technology to confirm the spread of newly diagnosed prostate cancer that is suspected to be metastatic. The approval also includes use for confirming suspected recurrence in men who have rising PSA after treatment. The approval is based on two clinical trials that showed this new technique to be safe and consistent in accurately detecting cancer that has spread beyond the prostate gland. (1/7/21)
THIS INFORMATION HAS BEEN UPDATED on 5/10/2022: On March 23, 2022 the U.S. Food and Drug Administration (FDA) approved a new drug called Pluvicto to treat patients with metastatic castration-resistant prostate cancer. ON the same day, the FDA also approved a new imaging drug called Locametz (a brand of Gallium 68 PSMA-11) for identification of those patients who would benefit from treatment with Pluvicto. Read about the FDA approval of Pluvicto and Locametz here.
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Contents
STUDIES AT A GLANCE
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 prostate cancer are diagnosed at advanced stages (they have spread beyond the prostate). The FDA 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 prostate ().
On December 1, 2020, the FDA approved a new imaging technique for detecting the spread of prostate 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 MRI (PET/MRI).
Gallium 68 PMSA-11 tracer:
The recent FDA 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 prostate cells, it is found at high levels in prostate cancer cells. Over the past decade, more research has focused on radioactive tracers that bind to to locate spread of prostate cancer to other regions of the body. Accurately detecting cancer spread can help doctors stage prostate cancer and develop treatment plans.
Research findings:
In the two multi-site studies that led to FDA approval, Ga 68 PSMA-11 was observed in two groups of men:
- men with newly diagnosed advanced prostate 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 () prostate cancer and were candidates for surgical removal of the prostate 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 lymph nodes. These results were confirmed by surgically removing the lymph nodes and then testing them for the presence of cancer cells.
Study #2
The second study included 635 men whose blood test suggested return of prostate cancer after treatment with radiation therapy or prostate 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 prostate gland in 74 percent of patients.
- These regions included bone, pelvic lymph nodes 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 FDA noted a possible risk for misdiagnosis of metastatic 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 prostate 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
References
Fendler W, Calais J, Eiber M, et al. Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Single-Arm Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):856-863.
FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer. FDA Website, December 1, 2020.
Disclosure
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.
- What tests have already been done to detect spread of my prostate cancer?
- Is Ga 68 PMSA-11 an option for detecting spread of my prostate 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 prostate cancer?
The following are studies looking at new methods for , monitoring and finding recurrence in people with prostate cancer.
- NCT02282137: 68Ga-PSMA PET-CT Scan for Diagnosis and Management of Prostate Cancer (PSMA). This study looks at the effectiveness of the 68Ga-PSMA-11 PET-CT scan to detect tumor location and measure size in patients with suspected or confirmed prostate cancer or prostate cancer that may have come back.
- NCT04030338: Prostate-Specific Membrane Antigen (PSMA) PET Scans to Find Prostate Cancer. This study will determine whether PET scans using PSMA are accurate and more effectively find prostate cancer than the standard methods.
- NCT04716725: 68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer. This trial assesses whether using 68Ga-PSMA-11 PET scans will help doctors learn more about the location of disease in the body.
- NCT04777071: An Investigational Scan (68Ga-PSMA-11 PET/CT) for the Imaging of Prostate Cancer. This trial studies how well 68Ga-PSMA-11 PET/CT scans work for imaging patients with prostate cancer.
- NCT04867603: Digital PET/CT Using [Ga-68]PSMA for Characterization of Prostate Lesions. This study evaluates a radioactive diagnostic drug called Gallium-68 Prostate Specific Membrane Antigen ([Ga-68]PSMA) to determine whether prostate abnormalities are cancer.
- NCT05160597: Image-Guided (68Ga-PSMA-11 PET/CT) Prostate Biopsy for the Diagnosis of Prostate Cancer in Men With Prior Negative/Inconclusive Biopsy. This study looks at how well an image-guided prostate biopsy using the imaging agent 68Ga-prostate-specific membrane antigen (PSMA)-11 with a PET/CT scan works in diagnosing prostate cancer in men with a prior negative or inconclusive prostate biopsy.
Several other clinical trials for monitoring patients with prostate cancer can be found here.
Updated: 05/29/2023
The following organizations offer peer support services for people with or at high risk for prostate cancer:
- FORCE peer support
- Visit our message boards.
- Once you register, you can post on the Diagnosed With Cancer board to connect with other people who have been diagnosed.
- Sign up for our Peer Navigation Program.
- Users are matched with a volunteer who shares their mutation and situation.
- Join our private Facebook group.
- Find a virtual or in-person support meeting.
- Join a Zoom community group meeting.
- Visit our message boards.
- ZERO-The End of Prostate Cancer is a nonprofit organization that provides information and support resources for men with prostate cancer.
Updated: 03/08/2023
Who covered this study?
New York Times
New scan finds prostate cancer cells hiding in the body
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