How Are These Drugs Used In Patients
The FDAs approval of piflufolastat F-18 covers its use in detecting prostate cancer in two types of patients:
- Those with a primary diagnosis, who may experience positive outcomes with surgery or other therapy, but have a high risk for the cancer spreading to other parts of the body
- Those whose cancer is suspected of having recurred based on elevated PSA levels in their blood
We need to understand how best to use this test and only employ it when its warranted, in these very specific situations, Dr. Beland says. Were not talking about giving it to everyone who comes in off the street.
The initial focus of piflufolastat F-18 PET scans is likely to be on patients with recurrent disease, says Sean Cavanaugh, MD, Chair of the CTCA® Department of Radiation Oncology.
There may be some concern that false readings indicating metastatic disease could lead some doctors to forego standard treatments, such as surgery or radiation therapy, that may potentially extend the life of patients who only have a primary tumor. The FDA acknowledges that there is a risk of misdiagnosis because piflufolastat F-18 binding may occur in other types of cancer as well as certain non-malignant conditions, which may lead to image interpretation errors.
Targeting Psma: Not Just For Imaging
Like a number of other radiopharmaceuticals, 177Lu-PSMA-617 has two components: a drug that delivers the therapy to cancer cells and a radioactive particle. In the case of 177Lu-PSMA-617, the delivery vehicle is PSMA-617, a drug that latches onto a protein called PSMA that is often found at high levels on the surface of prostate cancer cells. The radioactive component is lutetium-177, which is being tested as a part of multiple radiopharmaceutical drugs.
As Dr. Morris explained, PSMA-617 is extremely adept at finding and locking on to the PSMA protein on cells. Once it binds to PSMA on a cancer cell, the whole molecule is internalized by the cell and the cell is exposed to a lethal dose of radiation from lutetium-177, he said.
The PSMA protein is also at the heart of a new type of imaging procedure called PSMA PET. This form of PET imaging is just starting to be used in men with prostate cancer to determine whether their cancer has spread, or metastasized, beyond the prostate. In the last several months, FDA has approved two such drugs, known as radiotracers, for PSMA PET imaging.
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Evaluation In Men With Rising Psa After Primary Treatment
A second clinical trial enrolled 635 men who had rising serum PSA after initial prostate surgery or radiotherapy. All of these patients received a single Ga 68 PSMA-11 PET/CT scan or PET/MRI scan. Based on the scans, 74% of these patients had at least one positive lesion detected by Ga 68 PSMA-11 PET in at least one body region demonstrating that Ga 68 PSMA-11 PET can detect sites of disease in patients with biochemical evidence of recurrent prostate cancer, thereby providing important information that may impact the approach to therapy.
The FDA granted approval to the University of California, Los Angeles and the University of California, San Francisco.
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Ucla Ucsf Gain Fda Approval For Prostate Cancer Imaging Technique
Dr. Johannes Czernin and Dr. Jeremie Calais led the prostate cancer imaging studies for UCLA.
The University of Californias two nationally ranked medical centers, UCSF and UCLA, and their nuclear medicine teams have obtained approval from the U.S. Food and Drug Administration to offer a new imaging technique for prostate cancer that locates cancer lesions in the pelvic area and other parts of the body to which the tumors have migrated.
Known as prostate-specific membrane antigen PET imaging, or PSMA PET, the technique uses positron emission tomography in conjunction with a PET-sensitive drug that is highly effective in detecting prostate cancer throughout the body so that it can be better and more selectively treated. The PSMA PET scan also identifies cancer that is often missed by current standard-of-care imaging techniques.
UCLA and UCSF researchers studied PSMA PET to provide a more effective imaging test for men who have prostate cancer, said Dr. Jeremie Calais, an assistant professor at the David Geffen School of Medicine at UCLA. Because the PSMA PET scan has proven to be more effective in locating these tumors, it should become the new standard of care for men who have prostate cancer, for initial staging or localization of recurrence.
How it works
Fda Approves New Prostate Cancer Treatment
A targeted radioligand therapy, Pluvicto , has been approved for use in adults with previously treated metastatic castration-resistant prostate cancer . All eligible patients must have been previously treated with taxane-based chemotherapy and androgen receptor pathway inhibition, and test positive for a prostate-specific membrane antigen .
The efficacy of the treatment was evaluated in VISION, a randomized, open-label trial that compared best standard of care alone vs with lutetium Lu 177 vipivotide tetraxetan in 831 men with PSMA-positive mCRPC that was progressing. Patients were randomly assigned in a 2:1 ratio to receive either the best standard of care plus lutetium Lu 177 vipivotide tetraxetan, 7.4 GBq every 6 weeks until as many as 6 doses were given, or to the best standard of care alone.
VISION showed a statistically significant improvement in overall survival with lutetium Lu 177 vipivotide tetraxetan. For OS, the hazard ratio for the treatment plus best standard of care compared with best standard of care alone was 0.62 . In the treatment plus best standard of care arm, median OS was 15.3 months vs 11.3 months in the best standard of care alone arm.
The recommended dose of lutetium Lu 177 vipivotide tetraxetan is 7.4 GBq given intravenously every 6 weeks until 6 doses have been given, the cancer progresses, or unacceptable toxicity results.
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Fda Approves Second Psma
On May 27, 2021, the U.S. Food and Drug Administration approved piflufolastat F 18 , a drug for positron-emission tomography imaging of prostate-specific membrane antigen -positive lesions in patients with prostate cancer.
FDA approved the first PSMA-targeted PET imaging drug, Ga 68 PSMA-11, on December 1, 2020, for the same prostate cancer imaging indications as piflufolastat F 18. Ga 68 PSMA-11 is currently available only at two sites in California. Piflufolastat F 18 is anticipated to be distributed from multiple sites throughout the United States.
Piflufolastat F 18 is a radioactive diagnostic agent administered via IV injection. With approval, certain patients with prostate cancer will have greater access to PSMA-targeted PET imaging that can aid healthcare providers in assessing prostate cancer.
Safety and efficacy were evaluated in 593 patients with prostate cancer who each received one injection of piflufolastat F 18 in two prospective clinical trials. In the first trial, a cohort of 268 patients with biopsy-proven prostate cancer underwent PET/computed tomography scans performed with piflufolastat F 18. The patients were candidates for surgical removal of the prostate gland and pelvic lymph nodes and were considered at higher risk for metastasis. Patients who proceeded to surgery after positive readings in the pelvic lymph nodes on piflufolastat F 18 PET had a clinically important rate of metastatic cancer confirmed by surgical pathology.
Fda Approves New Imaging Tool To Find Advanced Prostate Cancer Drugmaker Says
The Food and Drug Administration has approved a new imaging agent to detect prostate cancer after it has spread to other parts of the body, the company that makes the agent said Thursday.
Prostate cancer is the second leading cause of cancer deaths in men in the United States, after lung cancer, according to the American Cancer Society. More than 34,000 men die of the disease every year.
When prostate cancer spreads, it often goes into the bones, said Dr. Michael Morris, a medical oncologist at Memorial Sloan Kettering Cancer Center in New York City. That makes it difficult to detect using traditional imaging techniques.
“It’s really hard to take pictures of what’s going on inside of bone,” Morris said, adding that traditional scans tend to find problems in the tissue surrounding bones, after damage has already been done.
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New Imaging Agent Helps Doctors Hunt Down Metastatic Prostate Cancer
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When prostate cancer metastasizes, doctors know that it most often will be found in bones, the lungs or the liver. But that doesnt always mean its easy to find. Metastatic cancer cells often nest in different places in the body in numbers so small, or form tumors so tiny, they may not show up on some scans.
Recently, however, the U.S. Food and Drug Administration approved a new imaging agent called piflufolastat F-18 to help make metastatic prostate cancer easier to find. The radioactive agent is designed to provide more complete information to doctors treating men diagnosed with recurrent or metastatic prostate cancer, giving them a clearer picture of whether their cancer has spread and where it may be found. It may also be used for some higher-risk patients with a primary prostate cancer diagnosis to see whether their cancer has already spread.
While the advance doesnt directly affect health outcomes for men with prostate cancer, it is pushing science forward as researchers look for new ways to identify and treat the disease. It may also help doctors and patients make more informed decisions on treatment options.
How To Receive A Psma Pet Scan And Prostate Cancer Care At Ucla Health
UCLA Health provides comprehensive and customized care for men with prostate cancer. Our physicians use the PSMA PET scan alongside radiation therapy, chemotherapy, surgery, and all other treatment modalities offered to make sure men receive the best possible care from diagnosis to treatment to follow-up.
To ensure the best treatment possible, UCLA Healths nuclear medicine physicians, medical oncologists, radiation oncologists, radiologists, urologists and surgeons optimize care for each person receiving treatment. The prostate cancer care at UCLA Health is backed by multidisciplinary tumor boards with physicians from different specialties and subspecialties, along with genetic counselors and representatives from allied health services. Together, these specialists and experts meet once a week to talk about each new cancer patient and the path forward for their specialized treatment.
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The Future Of Psma Pet
This is a solid study and reflects the real-world experience with PSMA PET-CT in other countries, Dr. Pomper said. Because there are several PSMA-targeted tracers, a next step will be to have them approved for use in the United States outside of clinical trials, he added.
He predicted that, eventually, the different PSMA tracers will be tested head to head.
The Australian trial adds to a growing body of research on improving the detection of metastatic tumors in men with prostate cancer. One imaging agent, fluciclovine F18 which targets prostate cancer cells in a different way than PSMA-targeted tracersis already approved in the United States for use in men with previously treated prostate cancer that appears to be progressing .
PSMA PET-CT is also being studied in this group of men, Dr. Shankar said. One small clinical trial that directly compared PSMA PET-CT with fluciclovine F18 PET-CT showed that the PSMA-targeted scan found more metastatic tumors, regardless of their location. NCI is funding a similar but larger clinical trial.
Dr. Pomper noted that PSMA also is found at relatively high levels in the vasculature of a number of other cancersincluding kidney, thyroid, and breastso hes hopeful that PSMA PET-CT might be useful beyond prostate cancer.
Urologists and radiation oncologists in many places are already ordering this scan as the standard of care, he said.
When And Why Are Pet Scans Used For Prostate Cancer
- Staging: A PET Scan is used for patients with known prostate cancer in order to pinpoint its exact location and to determine the extent of disease and to determine a treatment strategy.
- Planning Treatment: In some instances, a PET scan may be used to specifically target certain high-risk areas for special treatment. There are occasions when a PET scan is the only diagnostic test that can identify these otherwise hidden areas of cancer spread.
- Evaluation During and After Treatment: A PET Scan can be used during and after treatment of prostate cancer to determine the effectiveness or response of specific drugs and therapies.
- Ongoing Cancer Care After Detection of Biochemically Recurrent Prostate Cancer Restaging:A PET scan allows physicians to locate and assess the extent of recurrent prostate cancer. Specifically, a new radiopharmaceutical called Axumin has a superior ability to detect recurrent prostate cancer, even in very early stages and in patients with low PSA levels.
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Remission And The Chance Of Recurrence
A remission is when cancer cannot be detected in the body and there are no symptoms. This may also be called having no evidence of disease or NED.
A remission can be temporary or permanent. This uncertainty causes many people to worry that the cancer will come back. Although there are treatments to help prevent a recurrence, such as hormonal therapy and radiation therapy, it is important to talk with your doctor about the possibility of the cancer returning. There are tools your doctor can use, called nomograms, to estimate someoneâs risk of recurrence. Understanding your risk of recurrence and the treatment options may help you feel more prepared if the cancer does return. Learn more about coping with the fear of recurrence.
In general, following surgery or radiation therapy, the PSA level in the blood usually drops. If the PSA level starts to rise again, it may be a sign that the cancer has come back. If the cancer returns after the original treatment, it is called recurrent cancer.
When this occurs, a new cycle of testing will begin again to learn as much as possible about the recurrence, including where the recurrence is located. The cancer may come back in the prostate , in the tissues or lymph nodes near the prostate , or in another part of the body, such as the bones, lungs, or liver . Sometimes the doctor cannot find a tumor even though the PSA level has increased. This is known as a PSA recurrence or biochemical recurrence.
Closer To The Holy Grail
Currently PSMA PET/CT is not intended to be a screening tool. It is for those who have been diagnosed with prostate cancer and who either have a higher chance of it spreading or who have a recurrence and a rising PSA level after initial treatment. It is for men with suspected metastatic disease in their pelvis — for instance, in their lymph nodes, or outside of their pelvis in more distant lymph nodes, bones, or organs.”
“Our goal is to identify these sites early and to improve cure rates even though theyve had a relapse, so being able to see the disease is important knowledge, said Dr. Armstrong. Dr. Wong agreed. This advancement is much closer to the holy grail of precision and personalized medicine and will have a big impact on patient decision making and treatment options.
Risks Associated With Ga 68 Pmsa
The 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 patients 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 .
Highly Sensitive New Type Of Prostate Cancer Scan Gains Fda Approval
What this means for patients:Today, a new type of prostate cancer scan known as 68Ga-PSMA-11 PET was approved by the FDA. This new PSMA PET scan can detect prostate cancer metastases much earlier, when they are much smaller, which may help to improve treatment of patients with prostate cancer.
PSMA, short for Prostate Specific Membrane Antigen, is a protein that is found in relatively larger amounts on the surface of prostate cancer cells. PSMA PET is a new imaging technology that allows doctors to see PSMA using a PET scanner. Compared to the scans currently used for prostate cancer detection, such as CT, bone scans, and MRI, PSMA PET is more sensitive and can detect much smaller prostate cancer metastases. PSMA PET can now be used for initial and subsequent management decisions in patients with certain types of prostate cancer, in order to determine if and where they have metastases. Researchers are studying how PSMA PET may change treatment and, ultimately, patient outcomes like disease progression and survival.
How does it work? The strategy is based on a small-molecule PSMA binding chemical attached to a radioactive reporter . This conjugate is introduced into the circulation of a patient where the conjugate accumulates at sites of prostate cancer and the unbound conjugate clears rapidly from circulation. The patients body is passed through an imaging camera that records areas where the PET tracer accumulated.
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Axumin Pet Scanning For Prostate Cancer Care
Axumin is an FDA-approved agent used for Axumin PET scans for prostate cancer. Axumin is often able to image and restage recurrent prostate cancer better than any other conventional imaging techniques. Biochemical recurrence, typically suspected with rising PSA levels, is the standard in monitoring patients for suspected recurrent prostate cancer. Traditional imaging techniques are often limited in that they may detect a small lymph node or suspicious finding, but cannot further functionally characterize the molecular activity to determine the level of suspicion. The introduction of Axumin PET scanning has been a breakthrough, allowing physicians the ability to accurately locate and restage prostate cancer with precision, especially in the setting of suspiciously rising PSA levels.
How Do Axumin PET Scans Work?
An Axumin PET uses a radioactive tracer, given as an injection, that is linked to an amino acid which is absorbed by prostate cancer at a much more rapid rate than normal cells. The rapid uptake of Axumin by prostate cancer cells is then imaged by the advanced technology within the PET scan equipment. The PET scan images are then reviewed in order to determine if there has been any spread to other areas in the body.