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.

“Why Did I Get Prostate Cancer?”

Robins pausing for a drink and a bath in my yard on their way north; photo: BJ Gabrielsen

When something bad happens in the life of a ‘new’ Christian, they will often say “why is this happening to me?” (‘New’ here refers to one who has newly put their faith in Jesus and thus entered into a personal relationship with God.) When something bad happens in the life of a mature Christian (i.e one who has trusted God personally over a longer period of time), they will often say “Lord, why is this happening to me?” Notice they address God as “Lord”. Same basic questions, with different motivations. The new Christian may think it unreasonable that a bad thing has happened. But the mature Christian knows that problems are a part of life in an imperfect, fallen world. The mature Christian’s “Why?” question is meant to discern from God what he can learn from this difficult situation – how he might grow in faith and be of help to others in similar situations.

In the book of Genesis, God had revealed a distinct, seemingly positive plan for Joseph’s life. But when the teenage Joseph was sold by his brothers into slavery, he no doubt asked the “Why?” question. At first, he may have thought “what did I do to deserve this?” But later, his “Why?” question turned into an exclamation. “Oh, now I see why!” He realized God had sent him to Egypt to prepare a place for his father Jacob’s family to escape the famine in Canaan. In the end, Joseph was able to say to his brothers, “But as for you, you meant evil against me; but God meant it for good, in order to bring it about as it is this day, to save many people alive.” (Genesis 50:20)

When we experience difficulties in life, it is not wrong to ask “Why?” Just make sure we are asking for the right reason. God can indeed use our cancer experiences. There are no accidents in the life of a Christian. God has a plan and much to teach us as He guides us even through troubling times such as a cancer diagnosis.

Portions of the above were published in the May 17th, 2021 Turning Point devotional by David Jeremiah.

List of Prostate Cancer Drugs Approved or Under Development.

I have been compiling a list and brief description of such drugs as I learn about them from the scientific literature or other reliable sources. While my list of therapeutic agents under various stages of clinical development may not be complete, one can always search the site Recently three new therapies under development for advanced prostate cancer were added to my list, namely CCS1477, ARV-110 and most important, lutetium-177-PSMA. This list is always available from the website’s home page at the bottom.

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.

God Is At Work in All Things

As an ongoing cancer patient, I have often asked God why I was allowed to experience this cancer from 1995 until this day. It is often difficult to see first hand how God can use a difficult situation for His good and His glory. But remember, we still read the book of Job today in which he served as an amazing example of triumph through tribulation. So God can use every aspect of our lives, the negative as well as the postive, to affect our lives and the lives of those with whom we come into contact. The following video from Our Daily Bread Ministries addresses this very issue.

FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer

On Friday, December 18, 2020, the US FDA approved the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix (Orgovyx), for adult patients with advanced prostate cancer. This is an important advance because it offers another option to patients who are taking hormone therapy.

One of the mainstays of treatment for high-risk and metastatic prostate cancer is androgen deprivation therapy (ADT). ADT is designed to stop testosterone from being produced or directly block it from acting on prostate cancer cells, slowing or stopping cancer growth. Most forms of ADT are given as regular injections (e.g., monthly or every 3-4 months) or as implants under the skin. One disadvantage of commonly used medications is an initial spike in testosterone, as well as a delay in time to lowering the man’s testosterone level.

This newly-approved therapy, relugolix, works by blocking the pituitary gland (in the brain) from making hormones that stimulate the testes to make testosterone – thereby lowering a man’s testosterone levels. Instead of an injection, the patient takes an oral tablet once daily, at approximately the same time each day, with or without food.

The effects were tested in a randomized clinical trial comparing relugolix to leuprolide (Lupron), a very common injectable form of ADT, in over 900 patients with advanced prostate cancer. More patients taking relugolix had their testosterone levels fall quickly and remain at a low (“castrate” level) during the study vs those taking leuprolide.

Side effects of ADT can include weight gain, increase in cholesterol levels, and increased risk for heart attack. A striking finding in the clinical trial was a 54% decrease in major cardiac events (such as heart attack and stroke) in the patients taking relugolix vs leuprolide.

What does this approval mean for patients with advanced prostate cancer? They now have an oral alternative to typical ADT that decreases testosterone levels more quickly, and keeps them low, than one commonly used medication. Some patients and doctors may decide that taking an oral medication at home, rather than having to come to the clinic for an injection, may be preferable during the COVID-19 pandemic. Many men with prostate cancer already have risk factors for cardiovascular disease, and relugolix may offer reduced risk of dangerous side effects such as a heart attack. This may be an important consideration when choosing a form of ADT.

For those interested in accessing this medication, the therapy’s developer Myovant Sciences, has launched the Orgovyx Patient Support Program, which will offer patients access to a free trial of the therapy for up to two months, help with verification of insurance plans, copay support for commercially insured patients, and assistance for uninsured patients.

The above was published on December 21st, 2020 by the Prostate Cancer Foundation. For additional information to share with your health provider, see the following link published Jan. 26th, 2021 by the National Cancer Institute in its Cancer Currents Blog.