Aug. 20, 2025
Since 2022, lutetium Lu 177 vipivotide tetraxetan has been used to treat prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) after androgen receptor pathway inhibitor (ARPI) therapy and taxane-based chemotherapy.
Recently, the U.S. Food and Drug Administration (FDA) expanded the indication of lutetium Lu 177 for PSMA-positive mCRPC, tripling the eligible patient population.
The new FDA-approved indication allows for earlier use before chemotherapy. This new indication is for patients with PSMA-positive mCRPC who have undergone ARPI therapy and are considered appropriate for delayed chemotherapy treatment.
Results from the phase 3 PSMAfore trial, published in 2024 in The Lancet, show that lutetium Lu 177 vipivotide tetraxetan significantly reduces the risk of disease progression or death by 59%. The treatment also more than doubles the median radiographic progression-free survival compared with that of ARPI therapy. Side effects were low grade — primarily grade 1 to 2 — with the most frequently reported adverse events being dry mouth (61%), fatigue (53%), nausea (32%) and constipation (22%). Lutetium Lu 177 vipivotide tetraxetan does not impair subsequent chemotherapy effectiveness.
"PSMA-targeted radioligand therapy represents a meaningful step forward in managing metastatic castration-resistant prostate cancer," says Elisabeth I. Heath, M.D., chair of Oncology and professor of oncology at Mayo Clinic in Rochester, Minnesota. "Its introduction gives clinicians a new strategy to intervene earlier and potentially improve outcomes."
The implications
Each year, more than 35,000 people die of prostate cancer, and cases are on the rise. Half of patients diagnosed with mCRPC don't live long enough to receive a second course of treatment, highlighting the need for earlier use of effective therapies to treat the disease.
The FDA's change in indication means more patients with mCRPC can get lutetium Lu 177 vipivotide tetraxetan earlier in their cancer journeys. This gives more patients more options — and more hope for survival.
Advancing theranostics for all patients
As a global leader in treating serious, complex or rare cancers, Mayo Clinic is the world's largest user of theranostics, combining diagnostics and therapeutics in a single approach to cancer care.
Led by Dr. Heath — an internationally recognized expert in prostate, kidney and bladder cancer — the team of globally renowned advanced prostate cancer and radioligand therapy experts in Mayo Clinic Oncology in Minnesota is among the world's most frequent prescribers of lutetium Lu 177 vipivotide tetraxetan as treatment for mCRPC. This gives the team an unmatched level of expertise.
Having a robust team of experts means Mayo Clinic can treat a high volume of patients, often scheduling appointments in as little as 48 hours. For patients who may not be eligible for radioligand therapy, Mayo Clinic's robust clinical trial portfolio provides many other options for treatment and hope for the best possible quality of life.
Referring patients to Mayo Clinic provides you and your patients unparalleled access to lutetium Lu 177 vipivotide tetraxetan and other innovative new therapies. Mayo Clinic delivers the best possible outcomes and patient experiences with compassion, skill and expertise.
For more information
Morris M, et al. Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naïve patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): A phase 3, randomized, controlled trial. The Lancet. 2024;404:1227.
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