Kit for PSMA PET imaging agent gains FDA approval

The highly sensitive prostate cancer diagnosis scan called PSMA PET imaging will become more widely available in the U.S. following a new FDA approval.

Today, the FDA approved a kit for the production of the imaging agent 68Ga-PSMA-11 (trade name Illuccix®). 68Ga-PSMA-11 PET was the first type of PSMA PET imaging to gain FDA approval in December, 2020, initially at two centers in California. Going forward, this agent is expected to become available more broadly in the U.S. The kits will be distributed to a network of radiopharmacies that can manufacture 68Ga-PSMA-11, located across the country. From there, it will be delivered for use in PET imaging centers.

68Ga-PSMA-11 is approved for patients with prostate cancer 1) with suspected metastasis who are candidates for initial definitive therapy (i.e., newly diagnosed with high-risk disease) and 2) who previously had their prostate cancer treated, and are now seeing their PSA rise, in order to determine if and where they have metastases.

PSMA is a protein that is present in large amounts on the surface of prostate cancer cells, but is not present on most normal organs. Thus, it makes for an excellent imaging “target.” A small chemical that can bind to PSMA anywhere in the body is attached to a radioactive element (Gallium-68). Once injected into the patient, 68Ga-PSMA-11 travels to sites of prostate cancer and binds to PSMA. The Gallium-68 can be seen on a PET imaging scan. Compared with standard imaging, a PSMA PET scan can detect prostate cancer metastases earlier, when they are much smaller, which may help to improve treatment of patients with prostate cancer.

With this approval, patients and their doctors nationwide now have the option of two different PSMA PET imaging agents; the other is 18F-DCFPyL (trade name PYLARIFY). These agents can be considered interchangeable; in most cases, patients who are getting a PSMA PET scan can opt for the one that is most readily available to them.

PROMISE: A Clinical Trial of Inherited Genetic Factors Impact on Prostate Cancer Risk and Treatment Involving Free Genetic Testing.

It is known that prostate cancer may be written in some men’s genes, but so are instructions for discovering new treatments and understanding family risk. If we want to better understand prostate cancer, we have to better understand genes. That’s why the genetic information of prostate cancer patients is so important. This information is the next step in the collective fight against the disease. Yet, while 1 in 9 men will get prostate cancer and more than 4 million American men are currently living with the disease, genetic information is only beginning to be used for prostate cancer.

The PROMISE study is being launched to change all that. PROMISE seeks to learn more about the role genes can play in improving outcomes and/or treatments for prostate cancer patients. It will help understand how prostate cancer care can be tailored precisely based on a patient’s unique genetic profile. This means better information, testing and choices for you and others like you.

PROMISE research will examine how information about particular genetic profiles can:

a) Influence the susceptibility of men to prostate cancer;
b) Impact the effectiveness of existing treatments;
c) Improve guidance for different and/or new treatment options; and,
d) Suggest precise areas to explore for new discoveries.

How PROMISE works
PROMISE is completely free. Patients continue with their current provider and don’t even need to leave home to participate. Register online and we’ll send a simple, home-based DNA test kit. Just provide a saliva sample and return it via prepaid U.S. mail. The kit will screen for one of 30 cancer risk genes. We’ll send you the results and will provide a licensed genetic counselor to help you understand your results. You will learn if you have any gene mutations that might affect your care plan. The results may inform you of available treatment options and previously unknown risks of family members developing cancer. PROMISE will also create a new mechanism to communicate with prostate cancer patients on an ongoing basis to help connect them with new trials and treatments as relevant clinical trials are opened and approved for prostate cancer.

Benefits of joining the PROMISE study
Prostate cancer patients who join PROMISE will:

Receive free genetic testing and counseling that will help you learn important new information about genetic factors in your cancer and discover if you have a critical gene mutation that may impact your care plan.
Receive the most current information about new research, clinical trial opportunities, and treatments approved by the FDA. This information is sent via regular newsletters and updates.
Help family members understand their own risk of cancer and risk for future generations.
Make an important contribution to advancing research & understanding of prostate cancer by providing essential genetic information and long-term outcomes that are not available anywhere else.
Learn more
PROMISE is supported by a group of mission-driven nonprofit organizations. No pharmaceutical firms or any commercial interests are supporting this research. Participation is free and easy. Patients remain under the care of their current doctor. Patient’s don’t even need to leave home. Measures are in place to ensure safety, privacy and security.

Talk with your doctor about PROMISE and visit You can help win the fight against prostate cancer.

This information came from Zero-the Project to End Prostate Cancer

FDA Approves a Highly Sensitive Prostate Cancer Imaging Agent

On May 26th, the FDA approved another highly sensitive imaging compound specifically for prostate cancer called 18F-DCFPyL. This is the second such approval in less than six months; in December 2020, the FDA approved 68Ga-PSMA-11 PET (gallium-68 PET scan). These pioneering new scanning tools will revolutionize prostate cancer detection. Both imaging agents are used to “light up” PET scans to help doctors find smaller tumors earlier.

Both compounds are part of a new type of scanning technology called PSMA PET imaging. 68Ga-PSMA-11 and 18F-DCFPyL (or PyL for short) are radioactive tracer molecules designed to bind to PSMA that doctors can use to “light up” PET scans in regions that contain cancer. PSMA (“Prostate Specific Membrane Antigen”) is a protein found on the surface of prostate cancer cells. This new technology is more sensitive than conventional imaging (such as CT and bone scans) in finding areas of prostate cancer in the body. Having more complete and accurate information about where cancer is located can help doctors make better treatment plans. Finding metastases earlier, when they are much smaller, will have a significant impact for patients.

PyL PET imaging is approved for two types of patients with prostate cancer: 1) those with suspected metastasis who are candidates for initial definitive therapy (e.g., newly diagnosed with high-risk disease) and 2) those with suspected recurrence based on elevated PSA level (e.g. who previously had their prostate cancer treated, and are now seeing their PSA rise, in order to determine if and where they have metastases).

The main difference between PyL (trade name: PYLARIFY®) and 68Ga-PSMA-11 (approved in December, 2020) is that PyL can be commercially produced and shipped, which will make it available to any medical facility able to perform PET imaging. Currently the gallium-68 scan is only available in Los Angles, and San Francisco. Now, with 2 PSMA PET radiotracers approved, this type of imaging will become more widely available for patients. The PyL scan from Progenics and Lantheus hopefully will be widely available throughout the US by the end of 2021.

For more details, see the following post from the Prostate Cancer Foundation.

For a great article on PyL PSMA PET imaging, its develoment and use in dedecting small areas of cancer, see the following link.

Decipher Can Help Predict Metastasis and Whether Hormome Therapy is Needed in Recurrent Cancer.

Recurrent prostate cancer is usually treated with radiation alone or with the addition of hormone therapy. Doctors currently use certain criteria—like tumor grade and PSA level—to recommend whether patients with recurrent prostate cancer should get hormone therapy in addition to radiation. But studies have shown that these characteristics aren’t very good at identifying people who truly need the combination treatment. Because hormone therapy can cause distressing side effects—including hot flashes, loss of energy, and loss of sexual desire—the treatment is typically reserved for patients with aggressive cancer that is more likely to spread. Therefore it’s currently challenging to determine which patients have aggressive cancer that may require the addition of hormone therapy.

A new study found that the genetic biomarker test, called Decipher, may have the ability to do just that. The test looks at the activity of 22 genes in prostate tumor tissue and calculates a “risk of metastasis” score ranging from 0-0.45 (low), 0.45-0.6 (intermediate) and 0.6 – 1.0 (high). Using data from an NCI-sponsored clinical trial, researchers found that people with higher Decipher scores were more likely to have cancer that spread years later and to die from the cancer. The results, published February 11 in JAMA Oncology, also showed that hormone therapy helped people with higher scores live longer but was far less helpful for those with lower scores. For a more specific description of the Decipher test scores, see the following link to an article published March 15th by the National Cancer Institute Current Cancer Blog. A blog first describing Decipher was posted on this website in 2017.

Although the Decipher test was developed nearly a decade ago, the new findings are important because previously there wasn’t enough evidence to recommend its routine use in patient care. Decipher is already available to patients and the cost is covered by many insurance payers, including Medicare. Plus, it doesn’t require an additional procedure if tumor tissue is readily available from the patient’s prostate surgery. There are still many questions about how to use the Decipher test in different groups of patients with prostate cancer. About 20 ongoing clinical studies are looking to provide some answers.

Five Things to Know About PSMA-PET Scanning

A recent post on this website discussed the newly approved PSMA-PET scan for the detection of smaller areas of metastatic cancer. Here are five important pieces of information from the Prostate Cancer Foundation about the recently approved gallium-68 PSMA-PET scan. They are: 1) exactlywhat is PSMA-PET scanning? 2) how does it work? 3) is the radiation in PSMA-PET scans dangerous? 4) is PSMA-PET right for every cancer patient? and, 5) where can I get a PSMA-PET scan?. See the following link.

Finding Smallest Traces of Recurrent Cancer. FDA Approves First PSMA-targeted PET Imaging Agent for Prostate Cancer

The U.S. Food and Drug Administration (FDA) has approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) as a positron emission tomography or PET imaging agent for men with prostate cancer. The molecule is the first approved PET imaging agent that detects prostate cancer lesions by targeting the prostate-specific membrane antigen (PSMA) — a protein produced at high levels by prostate cancer cells.

It is approved for patients suspected of cancer recurrence, based on elevated blood levels of prostate-specific antigen (PSA), a prostate cancer biomarker. The agent also can be used for those with suspected prostate cancer metastasis — when the cancer spreads to distant regions in the body — who might be cured by surgery or radiation therapy. Other PET agents have been approved for detecting recurrent prostate cancer, but none for men whose cancer is suspected of spreading.

“With this first approval of a PSMA-targeted PET imaging drug for men with prostate cancer, providers now have a new imaging approach to detect whether or not the cancer has spread to other parts of the body,” Alex Gorovets, MD, acting deputy director of the office of specialty medicine in the FDA’s Center for Drug Evaluation and Research, said in a press release.

Ga 68 PSMA-11, developed by researchers at the University of California, Los Angeles and the University of California, San Francisco, is a radioactive agent meant to be given as an intravenous (into-the-bloodstream) injection prior to PET scanning. Once inside the body, it binds and accumulates inside prostate cancer lesions containing the PSMA protein, allowing clinicians to visualize these lesions in PET scans.

The decision to approve Ga 68 PSMA-11 was based, according to the researchers, on the results from two clinical studies involving 960 men with prostate cancer suspected of either cancer recurrence or metastasis.

The first was a Phase 3 trial involving 635 patients suspected of prostate cancer recurrence based on elevated PSA levels after initial prostate cancer surgery or radiation therapy. In this trial, Ga 68 PSMA-11 detected recurrent prostate cancer in 74% of participants, according to the researchers, and these lesions were proven as prostate cancer via other methods in 91% of cases.

The second Phase 3 trial included 325 patients with a confirmed prostate cancer diagnosis — either newly diagnosed or a confirmed recurrence — who were candidates for surgery, but considered at high risk for metastasis. Among those who had surgery, the men whose lymph nodes had signs of cancer on PET scans had a clinically important rate of metastatic cancer, which was confirmed by surgical pathology.

Having this information prior to treatment is expected to spare some patients from undergoing unnecessary surgery, the researchers said.

No serious adverse events, meaning undesirable side effects, occurred in either trial. The most common reactions included nausea, diarrhea, and dizziness.

The FDA noted that some risk for misdiagnosis exists, due to Ga 68 PSMA-11 binding to some other cancer types and to certain healthy tissues. There also is a degree of health risk from the compound’s radioactivity, which increases a patient’s long-term radiation exposure.

The preceding appeared in the Dec. 7th online edition of Prostate Cancer News Today by Forest Ray.

FoundationOne Liquid CDx “Liquid Biopsy” Blood Test Gets Expanded FDA Approval

Roseate spoonbill in southwest Florida; photo by Shutterstock

If you are considering genetic testing to identify whether a potential therapy might be useful against your prostate cancer, this article may be helpful to you. This test can help identify genetic changes such as BRCA1, BRCA2 and ATM mutations in which case a corresponding targeted drug, such as olaparib (Lynparza), may be useful.

The Food and Drug Administration (FDA) has expanded the approved uses for a blood test, known as a liquid biopsy, that can help doctors pick the best treatments for some people with cancer. The test identifies cancer-related genetic changes in DNA from tumor cells that have been released into the blood.

The test, called FoundationOne Liquid CDx, was approved by FDA earlier this year to identify patients with lung and prostate cancer who can receive specific targeted drugs. When the test is used in this way, it’s known as a companion diagnostic.

Under the expanded approvals, announced by FDA in late October and early November, the use of the test as a companion diagnostic has been broadened to people with other cancers and other drugs not covered by the original approval. (See table.)

FoundationOne Liquid CDx and another cancer liquid biopsy test, Guardant360 CDx, were initially approved by FDA earlier in 2020. Both approvals covered use of the tests as companion diagnostics for several targeted therapies. The initial approvals also covered the use of the tests for general tumor profiling, meaning they can be used to identify a large number of specific cancer-related genetic changes, any of which may influence patients’ treatment choices or make them eligible to participate in certain clinical trials.

According to FDA, the expanded approval of FoundationOne Liquid CDx was based on analyses of the test’s use on blood samples from patients participating in clinical trials evaluating the targeted drugs.

In instances where the blood test does not identify the specific genetic change that means a patient can receive a corresponding targeted therapy, the agency advised that the patient’s tumor tissue should be analyzed “to determine if the specific mutations and alterations are present.”

Most of the above was published by the National Cancer Institute (NCI) Current Contents Blog on November 30th, 2020.

PyL Prostate Cancer Imaging Agent Submitted to FDA for Approval

Lantheus Holdings has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval of PyL, an investigational imaging agent used to locate prostate cancer lesions. The new drug application (NDA) sent to the FDA includes a request for priority review, which if granted may shorten PyL’s regulatory review process from the usual 10 months to six. Lantheus expects the FDA’s decision on this filing in early December.

PyL, also known as 18F-DCFPyl, is a tracing agent used in positron emission tomography or PET scans to visualize prostate cancer lesions in different types of tissues. It does this by targeting the prostate-specific membrane antigen (PSMA), a protein commonly found on the surface of prostate cancer cells. Once bound to these cells, PyL emits a radioactive signal that can be seen in PET scans, signaling where these lesions are located.

The company’s NDA submission was supported by data from two clinical trials — OSPREY (NCT02981368) and CONDOR (NCT03739684) — that showed PyL can detect local and distant prostate cancer lesions that conventional imaging methods sometimes miss. Such detection makes tracking disease recurrence and spread more accurate, enabling doctors to adjust treatment plans appropriately.

In the Phase 2/3 OSPREY trial, PyL showed good sensitivity and specificity at identifying cancer lesions among 385 men, split into two groups. Group A included men with high-risk locally advanced prostate cancer, while group B involved men with metastatic or recurrent disease. Of note, in this context, sensitivity refers to PyL’s ability to identify true cancer sites, and specificity to its ability to distinguish cancer sites from non-cancer (healthy) sites.

Among men from group A, PyL had a specificity of 96-99%, a sensitivity of 31-42%, and a positive predictive value (PPV) of 78-91% at identifying cancer lesions in pelvic lymph nodes. The PPV is the proportion of patients with positive results who truly have the disease. In the group B participants, PyL had a sensitivity of 93-99% and a PPV of 81-88% at detecting metastatic cancer lesions, meaning those found farther away from the prostate. Metastatic cancer is disease that has spread to other parts of the body.

The participants tolerated PyL well and reported no serious undesirable side effects. The most frequent side effects observed included altered or unpleasant taste sensations and headaches.

The Phase 3, open-label CONDOR study evaluated PyL’s ability to safely and accurately detect prostate cancer lesions in 208 men with suspected disease relapse. All of the patients enrolled in the study had high levels of prostate-specific antigen (PSA), a biomarker of prostate cancer, but had negative or ambiguous imaging results. The study met its main goal, with PyL correctly locating cancer lesions in 85-87% of the patients. As a result of these findings, nearly 64% of participants saw changes in their treatment management plans.

Dr. Istvan Molnar, MD, chief medical officer of Lantheus, stated “we believe that the demonstrated strong diagnostic performance of PyL, will assist in treatment decisions and, ultimately, may improve patient outcomes,”

Much of the above appeared in the Oct. 6th, 2020 Prostate Cancer News Today, by Forest Ray.