Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a medicine that is used to treat certain types of prostate cancer. Pluvicto may be used to treat PSMA-positive prostate cancer that has spread to other parts of your body. PSMA stands for prostate-specific membrane antigen, and some prostate cancer cells have this on their surface, which makes it a PSMA-positive cancer. Pluvicto may be used with hormone therapy if the cancer has not yet been treated with certain hormone medicines or still responds to them. Or it may be used after hormone therapy has stopped working if chemotherapy can be delayed or if the person has already received chemotherapy.
If you have PMSA-positive prostate cancer, your health care provider can let you know if Pluvicto may be an option for your situation.
How Does Pluvicto Treat Prostate Cancer?
Pluvicto is a targeted radioactive medicine that works by targeting the PSMA protein on prostate cancer cells. The medicine attaches to the PSMA protein. This attachment is like a key going into a lock. Once the medicine has attached to the PSMA protein, it delivers radiation to the cell that damages the cell DNA and causes the cell to die. This helps to shrink the tumor and to prevent the tumor and cancer cells from growing and multiplying.
How Is Pluvicto Given?
Doses are given by an intravenous infusion through a blood vessel in your arm. Your health care provider may choose to give the dose by a few different methods that can take up to 30 minutes. Your dose of Pluvicto is measured by radioactive measurements and is usually given once every 6 weeks. If your cancer does not progress (grow or spread) and you do not have severe side effects, you may receive up to 6 doses of Pluvicto. If you have certain side effects, your health care provider may skip a dose of Pluvicto or stop your doses altogether.
How Well Does Pluvicto Work for Prostate Cancer Based on Studies?
Pluvicto was approved by the FDA based on several clinical trials. One trial, called VISION, compared Pluvicto plus standard treatment with standard treatment alone in people with progressive PSMA-positive prostate cancer who had already received hormone therapy and taxane-based chemotherapy. Standard treatment (or standard of care) refers to treatments that were commonly used for the condition when the trial began. In this trial, the best standard-of-care treatment could be chosen by the health care provider.
The clinical trial included 831 people who received one of the two treatments. They were followed to see how long it took for their prostate cancer to progress, meaning that the cancer grew or spread. This is called progression-free survival. The median progression-free survival was 8.7 months for Pluvicto compared to 3.4 months for people who had standard of care. This means that half of the patients who received Pluvicto did not have their cancer progress for at least 8.7 months.
This study also looked at median overall survival, which measured how long people in the study lived after starting the study. People who used Pluvicto in the study had a median overall survival of 15.3 months while people who had standard of care had a median overall survival of 11.3 months.
Another clinical trial, called PSMAddition, studied Pluvicto in people with PSMA-positive prostate cancer that had spread but had not yet stopped responding to hormone treatment. The trial compared Pluvicto plus an androgen receptor pathway inhibitor, which is a type of hormone therapy, with hormone therapy alone.
The study included 1,144 people. Half received Pluvicto plus hormone therapy, and half received hormone therapy alone. At the time of the analysis, the median progression-free survival had not yet been reached in either group. This means that more than half of the people in both groups had not yet had their cancer progress or died. However, people who received Pluvicto plus hormone therapy had a 28% lower risk of cancer progression or death than those who received hormone therapy alone.
Your results may differ from what was seen in clinical trials.
How Will I Know If It Is Working?
Pluvicto starts working in your body as soon as you receive your first dose. Your health care provider will usually do regular blood tests and scans to see how well your body is responding to the treatment. This can start during your first Pluvicto dose or after your doses, depending on what your health care provider thinks is right for you.
The blood tests will monitor your blood counts, such as white blood cells, neutrophils, and platelets, so that your health care provider knows that you can continue to use Pluvicto safely. If you have certain side effects, such as a change in your urine output, your health care provider may order additional tests to make sure it is safe for you to continue to use Pluvicto.
Other tests of your blood may include PSA (prostate-specific antigen), which is often used to monitor prostate cancer and how active it is in your body. If Pluvicto works for you, it usually causes the PSA to go down after you’ve received the medicine.
How Can I Prevent and Manage Pluvicto Side Effects?
Side effects are common with medicines that treat cancer, including Pluvicto. It is important to tell your health care provider about any side effects you have during or after using Pluvicto. They can help to determine if your side effects are serious or provide more information to help you manage the side effects.
Your health care provider will usually instruct you to take certain medicines before or during your Pluvicto infusion to help prevent the most common side effects, nausea and vomiting. It is important to follow their instructions. You can also ask your health care provider what else you can do to prevent or treat common side effects. For example, eating bland foods and having multiple small meals throughout the day instead of three large meals can help to prevent and treat nausea and vomiting.
If you have certain side effects while you use Pluvicto, your health care provider may need to pause your infusions or even stop your infusions altogether. This will depend on the side effect you experience, how severe it is, and what treatment it needs. If your Pluvicto dose needs to be paused, your health care provider may restart the medication once your side effects are treated.
What Are Other Considerations to Be Aware Of?
Pluvicto can harm a fetus. Tell your health care provider if you or your partner are planning to become pregnant. It’s also possible for Pluvicto to cause temporary or permanent infertility in men and people assigned male at birth. Talk with your health care provider about the risks to your fertility and any family planning you should do before using Pluvicto. If you have a partner who is able to become pregnant, it is important to use contraception while you are being treated with Pluvicto and for 14 weeks after your last dose.
You should also talk with your health care provider if you live with children or people who are or may become pregnant. This is important because you will need to avoid close contact with children and pregnant people after you use Pluvicto. After you use Pluvicto, the maker of Pluvicto recommends the following precautions.
- Stay at least 3 feet away from children for 2 days.
- Stay at least 3 feet away from pregnant people for 7 days.
- Sleep in a separate bedroom or space:
- From other household members for 3 days
- From children for 7 days
- From pregnant people for 15 days
- Avoid sexual activity with another person for 7 days.
Is There Any Cost Assistance Available?
The drugmaker of Pluvicto may offer cost assistance programs for Pluvicto. To learn more, visit this website or call 844-638-7222.
