OHSU researchers ‘instrumental’ in studying newly FDA-approved treatment for a form of prostate cancer

Health Care , Research
OHSU researchers ‘instrumental’ in studying newly FDA-approved treatment for a form of prostate cancer
OHSU researchers ‘instrumental’ in studying newly FDA-approved treatment for a form of prostate cancer
A doctor and male patient wearing masks stand in a hospital hallway talking.
A doctor talks with a patient about prostate health in the corridor of a hospital. (Getty Images)

Patients with metastatic castration-resistant prostate cancer — the most aggressive and deadly type of the disease — now have a new Food and Drug Administration-approved form of treatment.

The FDA recently approved a new therapy, called Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan), formerly referred to as 177Lu-PSMA-617, based on the results of the Phase III VISION clinical trial. The treatment is an option for men with prostate cancer that has spread and become resistant to hormone therapy and chemotherapy. The infused treatment combines a targeting compound with a radioactive isotope to irradiate and kill cancer cells.

According to the American Cancer Society, prostate cancer is the second leading cause of cancer death in American males, and kills 34,000 people in the U.S. every year.

Tom Beer, M.D., F.A.C.P. is a man wearing a white coat, stethoscope, and glasses in a hospital.
Tom Beer, M.D., F.A.C.P. (OHSU)

OHSU’s Tom Beer, M.D., led the VISION trial at OHSU, and co-authored the VISION study presentation at the American Society of Clinical Oncology Annual Meeting in June 2021, as well as the resulting The New England Journal of Medicine publication.

“This is a significant new treatment for patients with prostate cancer who previously had few options,” says Beer, the deputy director of the OHSU Knight Cancer Institute. “FDA approval of this therapy could be a lifeline for many patients, and I am proud that OHSU helped bring this treatment to patients who desperately need it.”

The study, sponsored by Endocyte, Inc., a Novartis company, tested the targeted radioligand therapy in participants with advanced prostate cancer. All subjects had cancers that had spread to other organs and continued to progress after previous treatment with two kinds of drugs, androgen axis inhibitors and taxanes. The experimental treatment significantly extended survival, delayed progression and was generally tolerated by study subjects, researchers said.

The OHSU Knight Cancer Institute was among the top sites for enrolling subjects, which meant men with prostate cancer in Oregon have had the opportunity to access this drug as part of research long before the therapy’s FDA approval. Study enrollment required close collaboration between the Knight Cancer Institute’s prostate cancer program and OHSU’s innovative nuclear medicine team, led by Erik Mittra, M.D., Ph.D., professor of diagnostic radiology in the OHSU School of Medicine. Nuclear medicine focuses on using radioactive materials to diagnose and treat a variety of cancers.

Beer says the contributions of the OHSU nuclear medicine team, led by Mittra and Nadine Mallak, M.D., were critical to the OHSU study team. Following the successful Phase III study results, Beer says the two teams worked hard to make the much-anticipated therapy accessible to metastatic prostate cancer patients under an expanded access protocol on a limited basis, prior to official FDA approval.

“Drs. Mittra and Mallak’s contributions have brought state-of-the-art nuclear medicine to patients in Oregon,” Beer says. “And the leadership of Dr. Fergus Coakley, the chair of diagnostic radiology at OHSU, cannot be understated. The radiology group is a remarkable asset to the prostate cancer program and serves patients across the cancer spectrum at OHSU.”

The drug carries the radioactive isotope Lutetium-177 and targets prostate-specific membrane antigen, or PSMA, a protein that appears on the surface of most prostate cancer cells. More than 80% of advanced prostate cancers bear the PSMA protein, and patients with PSMA-bearing tumors can be identified with a PET scan.

“Because the treatment has been tolerated in patients to date, this will be a significant advance for patients with prostate cancer,” says Beer, who also directs the OHSU Prostate Cancer Research Program. “It represents yet another cancer drug approval and change in standard of care that Knight Cancer Institute investigators contributed to.”

The OHSU Knight Cancer Institute is a national leader in prostate cancer treatment and research, expanding access to clinical trials and the newest treatments. With the VA Portland Health Care System, the Knight Cancer Institute has established a center of excellence for prostate cancer precision oncology.

Since 2011, the OHSU prostate cancer program team has contributed to FDA approvals for five different forms of prostate cancer therapy: docetaxel, enzalutamide, abiraterone, apalutamide and now Pluvicto.

Disclosure: The clinical trial was funded by Endocyte, Inc, a Novartis company. OHSU received research funding from Novartis.


Amanda Gibbs
Communications Manager, OHSU Knight Cancer Institute
503-494-8231