The Prostate Cancer Foundation recently posted a blog describing the best dietetic advice for those of us with prostate cancer. The benefits of extra virgin olive oil, tomatoes, coffee, tea, fish, nuts, soy and vitamin D are described. See the following for detail.
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Long Term Hormone Therapy Raises Risk of Cardiovascular Death
If you have been on hormone therapy (androgen deprivation therapy, ADT) for significant periods of time, e.g. greater than six months, this blog has some valuable information and recommendation for you. A new study reports that long-term exposure to androgen deprivation therapy (ADT), a common treatment for prostate cancer, is associated with worse cardiorespiratory fitness and a higher risk of cardiovascular death. Men who received ADT therapy for more than six months were ultimately found to have a nearly four times higher risk of death than those not exposed to the therapy. The scientists from Brigham and Women’s Hospital and Dana Farber Cancer Institute, both in Boston, noted that further research will be necessary to determine whether cardiovascular-targeted interventions, like exercise, might help reduce cardiovascular risk in prostate cancer patients undergoing long-term ADT. For us with prostate cancer, physical exercise and strengthening are both valuable habits.
For a full article, see the Jan. 11th, 2021 Prostate Cancer News Today.
Foods to Eat to Combat Cancer
Attached is a link to a pictorial table of specific vegetables and fruits to eat which contain nutrients to combat cancer and other conditions. Try to eat three every day. The table comes from the Prostate Cancer Foundation.
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
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.
Study Finds That Provenge Improves Survival in mCRPC Patients Over Xtandi, Zytiga.
Provenge (sipuleucel-T) by Dendreon Pharmaceuticals, is superior to Zytiga (abiraterone acetate) or Xtandi (enzalutamide) at prolonging the lives of men with metastatic castration (hormone)-resistant prostate cancer (mCRPC) when added at any point in a treatment regimen, according to a real-life study in the U.S.
The study, “A Retrospective Observational Analysis of Overall Survival with Sipuleucel-T in Medicare Beneficiaries Treated for Advanced Prostate Cancer,” was published in the journal Advances in Therapy.
“Men with mCRPC who received [Provenge] had a significant improvement in median overall survival and reduction in the risk of death at three years, regardless of line of use,” according to Rana R. McKay, MD, the study’s lead author at the University of California, San Diego.
“This analysis underscores the importance of using complementary mechanisms of action to maximize patient survival outcomes and highlights the critical role immunotherapy plays in the modern era of mCRPC treatment,” said Bruce A. Brown, MD, Dendreon’s chief medical officer. “Provenge continues to deliver on its promise of helping men with advanced prostate cancer live longer and should be considered when making treatment decisions in daily clinical practice,” Brown added.
Approved in the U.S. in 2010, Provenge is the only immunotherapy that uses a patient’s own immune cells to fight prostate cancer. It consists of an individual’s white blood cells that have been exposed to a prostate cancer protein, ultimately priming them to activate the remaining immune cells to fight cancer.
In the years since Provenge’s approval, the oral agents Zytiga and Xtandi — second-generation androgen-receptor signaling pathway inhibitors (ASPIs) — have become the standard-of-care treatment for men with mCRPC. Currently, both ASPIs and Provenge are recommended as a first-line treatment for the same indication. However, no study to date has compared the effectiveness of Provenge with that of the ASPIs. To fill this knowledge gap, Dendreon researchers and colleagues retrospectively analyzed the survival outcomes of 6,044 men with mCRPC who received either Provenge or ASPIs (Zytiga or Xtandi).
The current study explored differences in the survival outcomes, adjusted for multiple factors available in the dataset that could potentially influence the patients’ risk of death.
The results showed that men treated with first-line Provenge lived significantly longer (34.9 months; nearly three years) than those receiving ASPIs as first-line therapy (21 months; just less than two years), reflecting a 44% reduced risk of death at three years. Further, adding Provenge to either Zytiga or Xtandi at any point of the treatment regimen reduced the risk of death by 41% and prolonged median overall survival by 14.5 months (just over one year). Specifically, overall survival was 35.2 months with any-line Provenge versus 20.7 months without the immunotherapy.
These findings highlight that including Provenge at any point during treatment prolongs the life of men with mCRPC by more than one year and reduces their risk of death by more than 40%.
Moreover, exploratory analyses suggested that patients who received both Provenge and an ASPI during their treatments saw their risk of death reduced by 52% compared with only one ASPI or two sequential ASPIs.
“These findings support the need for further research to explore treatment sequences and therapeutic combinations,” the researchers wrote.
For additional details, see the October 26th issue of Prostate Cancer News Today by Marta Figueiredo.
Targeted SBRT Radiation Reduces Pain From Metastases to the Spine
The following Nov. 24th article from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) describes recent clinical trial findings that for some patients with painful spinal metastases from advanced cancer, a type of precise, high-dose radiation therapy (SBRT) may be a highly effective way to relieve that pain. About a third of people in the clinical trial who received this form of radiation therapy, called stereotactic body radiation therapy, or SBRT, for spinal metastases were pain-free up to 6 months after treatment compared with only about 15% of people who received conventional external beam radiation therapy to treat the pain.
This study included about 200 people with three or fewer spinal metastases in a concentrated area of the spine that were the sole source of their pain. None had measurable signs of instability in the bones of the spine, which would increase the risk of fracture and make it harder to assess pain.
The study’s principal investigator noted that “this isn’t for the patient who has pain everywhere in the spine, which is unfortunately the majority of patients. But if you have a defined region of metastatic disease in the spine, and you can pinpoint the pain to that region, that’s going to be who benefits.” See the entire article for details.
Feeling Overwhelmed?
I hope today finds you all doing well and healthy. But, as cancer survivors, we all have had days wherein we were feeling overwhelmed either with the disease itself or our anxieties. So for those days, I pass along this message I recently received from YouVersion entitled “You Are Not Alone.”
If you are unsure of your personal relationship with God through Jesus Christ, see the following.
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.