What Is Pluvicto for Prostate Cancer? How This Targeted Treatment Works and Who May Qualify
For people with advanced prostate cancer, treatment can become increasingly difficult as the disease spreads or stops responding to hormone-based therapies. A targeted treatment called Pluvicto offers another approach: it uses a molecule designed to seek out prostate cancer cells carrying a protein called prostate-specific membrane antigen (PSMA).
The treatment has been used for certain patients with advanced prostate cancer since the US Food and Drug Administration (FDA) first approved it in 2022. But its potential role has expanded.
On 31 July 2026, the FDA approved Pluvicto in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with PSMA-positive metastatic prostate cancer that has not previously received, or remains sensitive to, androgen pathway modulation.
So what exactly is Pluvicto, how does it work, and who may qualify?
What Is Pluvicto?
Pluvicto is the brand name for lutetium Lu-177 vipivotide tetraxetan, a type of targeted cancer treatment known as a radioligand therapy.
It is part of an approach called theranostics, which combines diagnosis and treatment. The basic idea is to first identify cancer cells carrying a particular target and then use a similar molecule to deliver treatment specifically to those cells.
In prostate cancer, that target is PSMA, a protein found on the surface of most prostate cancer cells.
As the University of Chicago Medicine explains, a PSMA-targeting tracer can first be used during a PET scan to identify cancer cells. If the cancer takes up the tracer, a corresponding therapeutic compound can then deliver radioactive particles to those cells.
How Does Pluvicto Work?
Pluvicto is given intravenously. Once in the bloodstream, its targeting molecule seeks out and binds to PSMA on prostate cancer cells.
Attached to that molecule is lutetium-177, a radioactive isotope. When Pluvicto binds to a PSMA-positive cancer cell, the radiation damages the cell's DNA, ultimately causing the cancer cell to die.
This is different from conventional external-beam radiotherapy, in which radiation is delivered from outside the body towards a specific area.
The treatment is therefore targeted, but not perfectly exclusive to cancer cells. Some healthy tissues also express PSMA, which helps explain why side effects can occur.
What Is a PSMA PET Scan?
Before receiving Pluvicto, patients need to establish that their cancer is PSMA-positive.
This is generally done using a specialised PSMA PET scan. In the US, the FDA-approved imaging agent Locametz, whose active ingredient is gallium Ga 68 gozetotide, can be used to identify PSMA expression.
During the scan, a small amount of radioactive tracer is injected into a vein. The tracer travels through the body and attaches to PSMA-expressing cancer cells, allowing them to be visualised on a PET scan.
The result helps doctors determine whether Pluvicto is an appropriate treatment option. The University of Chicago Medicine notes that the imaging can also show where prostate cancer has spread throughout the body.
Who May Qualify for Pluvicto?
Eligibility depends on the stage and characteristics of the cancer, previous treatment, and the regulatory indication in the country where the patient is being treated.
The latest US approval means Pluvicto can now be used alongside an ARPI for adults with PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer. This category was previously referred to as metastatic hormone-sensitive prostate cancer. Patients must be selected using PSMA PET imaging.
Pluvicto also remains an option for certain people with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). In 2025, the FDA expanded its indication to include adults whose cancer had progressed after ARPI therapy and who were considered appropriate to delay taxane-based chemotherapy, as well as certain patients who had already received taxane chemotherapy.
In practical terms, Pluvicto is not a treatment for every person diagnosed with prostate cancer. It is intended for selected patients whose cancer has spread and whose tumours demonstrate the biological target needed for the treatment to work.
Eligibility criteria also differ between regulatory systems, so patients should discuss their individual circumstances with their oncology team.
What Does the Latest Research Show?
Evidence for Pluvicto has come from several clinical trials.
The original VISION trial involved 831 people with PSMA-positive metastatic castration-resistant prostate cancer who had previously received other anticancer treatments. Patients received Pluvicto plus standard care or standard care alone.
The results showed a significant survival benefit. Median overall survival was 15.3 months with Pluvicto plus standard care compared with 11.3 months with standard care alone.
More recently, the PSMAfore trial examined Pluvicto in people with PSMA-positive mCRPC who had progressed after one ARPI and were considered suitable to delay taxane chemotherapy. Median radiographic progression-free survival was 9.3 months with Pluvicto compared with 5.6 months with an ARPI change.
These results suggest that the role of radioligand therapy could be moving earlier in the treatment pathway for selected patients.
How Is Pluvicto Given?
Pluvicto is administered via intravenous infusion rather than as a tablet.
The standard regimen used in the clinical studies has been 7.4 GBq (200 mCi) every six weeks, for up to six doses, although the exact treatment plan depends on the indication and a patient's clinical circumstances.
At the University of Chicago Medicine, patients receiving Lu-177 PSMA therapy are monitored between treatments, including through blood tests, to check for side effects and assess how they are responding.
What Are the Side Effects?
Because Pluvicto carries radioactive material, treatment requires specialist handling and monitoring.
Commonly reported problems include fatigue, nausea, and dry mouth. The dry mouth can occur because salivary glands contain some PSMA and can therefore absorb part of the treatment. Blood cell counts can also fall temporarily.
The FDA prescribing information also warns about potentially serious complications, including bone marrow suppression and kidney toxicity, which is why patients require medical monitoring during treatment.
The radiation exposure also means patients may receive specific instructions after treatment to reduce unnecessary exposure to other people.
Is Pluvicto a Cure for Prostate Cancer?
No. Pluvicto is not considered a cure for metastatic prostate cancer.
Instead, its goal is to control advanced disease, delay progression and, where possible, help patients live longer while maintaining their quality of life. The University of Kansas Cancer Centre similarly describes Pluvicto as a treatment that can extend life and improve quality of life rather than cure metastatic disease.
Its growing role does, however, represent a significant shift towards precision treatment in advanced prostate cancer.
Rather than treating every cancer cell in the same way, doctors can use molecular imaging to determine whether a patient's tumour carries the right target and then deliver radioactive treatment directly to those cells.
For eligible patients, that could mean another option when conventional treatments become less effective, and, following the latest FDA approval, potentially an opportunity to introduce targeted radioligand therapy earlier in the course of metastatic disease.