Cedars-Sinai Cancer investigators have identified two promising new treatment options for men with recurrent prostate cancer—both of which helped patients live longer without their disease progressing than the current standard treatment. The results of their international Phase III clinical trial were published today in the New England Journal of Medicine.
“If these treatments are approved by the Food and Drug Administration, our results will be practice changing,” said Stephen Freedland, MD, associate director for Training and Education and the Warschaw, Robertson, Law Families Chair in Prostate Cancer at Cedars-Sinai, and lead author of the study. “In the study, both of these new options improved metastasis-free survival while preserving quality of life.”
Cancer of the prostate, a walnut-sized gland that helps make semen, will be diagnosed in 288,300 men in the U.S. in 2023, according to American Cancer Society estimates. For some, treatment may never be needed because they have a slow-growing form of the disease, but those with more aggressive prostate cancer are often first treated with surgery or radiation therapy.
“Unfortunately, in about a third of those patients, the cancer recurs within 10 years,” Freedland said.
Patients with aggressive recurrence are treated with androgen deprivation therapy (ADT), also known as hormone therapy, which reduces the patient’s production of the male sex hormone testosterone. Testosterone helps prostate cancer cells grow and spread, and the hormone therapy effectively reduces the growth-stimulating effects. But Freedland said ADT has two downsides: It doesn’t completely eliminate testosterone, and it can cause many side effects.
“When you go on ADT, the testosterone level in the blood is reduced, but not completely eliminated,” Freedland said. “And the concern is that the testosterone that remains may still be enough to stimulate tumor growth. Also, patients don’t love the idea of being on hormones.”
In this study of 1,068 prostate cancer patients from 244 sites in 17 countries, Freedland and fellow investigators tested two experimental interventions—one to address each of these issues.
In the randomized clinical trial, one-third of the patients received ADT plus a medication called enzalutamide, which blocks the effects of testosterone. Enzalutamide keeps any testosterone remaining in the blood from stimulating the growth of cancer cells.
Another third of the patients received enzalutamide alone. This option relied on the medication to block the effects of testosterone even though testosterone levels in the patients’ blood were not reduced.
“We wanted to see whether enzalutamide on its own was so effective that we didn’t need the ADT,” Freedland said.
The final group of patients received ADT alone, which is the current standard treatment.
Investigators found that the combination of ADT plus enzalutamide reduced the risk of metastasis or death by 58% over ADT alone. They found that enzalutamide alone reduced the risk of metastasis or death by 37% over ADT alone. Both treatments maintained quality of life relative to the ADT alone.
“While the combination therapy offers greater risk reduction, some men might prefer enzalutamide alone. It does a good job of preventing cancer spread or death, with different side effects that may be more acceptable for some men,” Freedland said.
The next step is for the makers of enzalutamide to apply for FDA approval, so the experimental therapy can come into wide use, Freedland said.
“Optimizing therapy for patients with aggressive recurrence after their prostate cancer is initially treated has been an unmet need,” said Dan Theodorescu, MD, Ph.D., director of Cedars-Sinai Cancer and the PHASE ONE Distinguished Chair. “The results of this trial point the way to two options which the study showed were more effective than current standard of care, giving these patients and their providers the opportunity to choose a potentially improved course of therapy that best meets their needs.”
More information: Stephen Freedland et al, Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer, New England Journal of Medicine (2023). www.nejm.org/doi/10.1056/NEJMoa2303974
News
UCLA Scientists Uncover a “Hidden Weakness” in Some of the World’s Deadliest Cancers
A new study has uncovered an unexpected vulnerability in some of the deadliest cancers. Researchers at UCLA have identified a previously hidden weakness in some of the most aggressive cancers, pointing to a possible new way [...]
AI-designed universal coronavirus vaccine clears first human trial
Key Takeaways Super-Antigen Technology: Uses AI and machine learning to analyze viral genomes, creating a single vaccine that targets essential features across entire virus families, including coronaviruses and Ebola. Human Trials & Safety: Phase [...]
Researchers Discover a Hidden Vitamin D Problem That Persists Year-Round
A new study suggests that some groups may not experience the expected seasonal boost in vitamin D levels, even during the sunniest months of the year. Many people assume that spending more time outdoors [...]
Researchers Solve the Mystery Behind a Billion-Dollar Dental Implant Disease
Researchers have uncovered why a common and costly dental implant infection often resists antibiotics. Dental implants have helped tens of millions of people regain a full set of stable, functional teeth, something traditional dentures [...]
Nanoparticles inspired by lung fluid improve therapies targeting respiratory system
The CIC biomaGUNE Center for Cooperative Research in Biomaterials has developed pulmonary surfactant nanoparticles (the blend of lipids and proteins that line the alveoli and enables breathing), which are encapsulated [...]
Scientists Finally Uncover How a “Forever Chemical” Causes Birth Defects
PFDA, a PFAS “forever chemical,” can cause craniofacial birth defects by disrupting retinoic acid regulation during fetal development, revealing the first clear molecular mechanism behind the link. Researchers have long linked perfluoroalkyl and polyfluoroalkyl substances (PFAS), [...]
Scientists Have Discovered These Deadly Parasites Are Secretly Swapping DNA
Leishmania parasites appear to evolve through widespread genetic exchange, reshaping assumptions about how they adapt and spread. A parasite long thought to spread mostly by cloning itself may be far more genetically dynamic than [...]
Stanford’s Revolutionary New Microscope Reveals Living Cells in Stunning Detail
Stanford researchers have developed a microscope that can show how nanostructures interact inside living cells at the highest resolution achieved so far. The view into living cells just got better. Stanford researchers have merged [...]
What Bundibugyo Ebola vaccines and treatments are under development
By Mariam Sunny and Jennifer Rigby May 29 (Reuters) – Global health authorities are racing to identify medical options to help contain an Ebola outbreak in eastern Democratic Republic of Congo, linked to the [...]
Why More People in Their 30s Are Suddenly Getting Colon Cancer
A major Swiss study found that colorectal cancer is becoming increasingly common in adults under 50, even as rates decline in older age groups. Researchers in Switzerland have identified a concerning trend: while colorectal [...]
Researchers Compare MS Models to Human Tissue in Search for Better Therapies
Researchers identified key differences between two widely used multiple sclerosis models, showing how each can better study myelin damage, immune responses, and repair. The findings may improve efforts to develop treatments that restore lost [...]
Scientists Discover Genetic “Off Switch” That Supercharges CAR T Cells Against Cancer
A new study reveals a possible way to make CAR T-cell therapy more durable and effective by targeting a single gene-regulating protein. CAR T-cell therapy is widely seen as a breakthrough in personalized cancer [...]
New Vitamin B12-Based Therapy Could Change How Brain Cancer Is Treated
Researchers have identified a vitamin B12–based compound that appears capable of crossing the blood–brain barrier and selectively accumulating in glioblastoma tissue. For decades, one of the biggest problems in brain cancer treatment has had [...]
Simple Fiber Supplement Cuts Knee Arthritis Pain in Just 6 Weeks, Study Finds
A daily inulin supplement may help reduce knee osteoarthritis pain while revealing a possible link between gut health, muscle function, and pain sensitivity. For millions of people living with knee osteoarthritis, managing chronic pain [...]
This Common Vitamin May Help Stop Prediabetes From Turning Into Diabetes
Vitamin D may help prevent type 2 diabetes in people with specific genetic variations, offering a possible path toward personalized diabetes prevention. More than 40% of U.S. adults have prediabetes, a condition in which [...]
Ebola, hantavirus: Is the world prepared for the next pandemic?
Funding cuts to health research and a growing antivaccine movement are making it harder than ever to respond to viruses. The World Health Organization (WHO) has declared that an Ebola outbreak in Uganda and [...]
