Update: New first-line treatment option for metastatic prostate cancer
Most relevant for: People with metastatic castration resistant prostate cancer who have an inherited or tumor mutation in certain genes.. It may also be relevant for:
- people with prostate cancer
- people with castration-resistant prostate cancer
- people with a genetic mutation linked to cancer risk
- people with a family history of cancer
Research Timeline: Post Approval
What is this update about?
The (Food and Drug Administration) approved together with Xtandi as a treatment for people with castration-resistant cancer (mCRPC). This approval is for people who have an or tumor mutation in the following genes: , , , ATR, CDK12, , FANCA, MLH1*, MRE11A, , or . is given with Xtandi, which is already used to treat prostate cancer.
*Although mutations are included in the approval, works differently to repair damage than the other listed genes.
Why is this update important?
prostate cancer can be hard to treat, but effective first treatments may help people live longer and healthier lives. This approval offers a new first treatment for some mCRPC.
Xtandi is standard hormone therapy used to treat mCRPC. It works by blocking testosterone.
is a type of known as a . Several different PARP inhibitors are used to treat mCRPC. In addition to being used for cancer, PARP inhibitors also treat certain breast, ovarian and pancreatic cancers.
The research behind the approval
This approval is based on the results of a clinical trial called TALAPRO-2. Half of the participants in the trial took Xtandi with . The other half took Xtandi and a sugar pill (). Neither the participants nor the doctors knew who took and who took the . and Xtandi improved outcomes for all people with mCRPCs. However, people whose tumors had mutations in certain genes responded especially well to this drug combination.
People who took went longer without their cancer growing or spreading than participants who received the . Early results suggest that people with a mutations may respond especially well to . The drug greatly reduced the risk of cancer spreading in people with a mutation compared to people without a gene mutation.
The most common side effects of were low red blood cells and fatigue. Participants in the trial also experienced other side effects, including lower appetite, dizziness, nausea, fractures and changes to taste. Low mineral (sodium, calcium, magnesium and potassium) levels were also common.
Among people taking , about 2 in 5 needed at least one blood transfusion, and 1 in 5 needed multiple transfusions. Two people on the trial developed leukemia.
What does this mean for me?
Experts recommend that everyone with mCRPC have genetic testing for an linked to cancer. Results from this test may affect your treatment options and may also help your relatives learn about their risk for cancer and take steps to prevent cancer. If you have mCRPC and have not had genetic testing, ask your doctor for a referral for genetic counseling and testing.
Experts also recommend that people with mCRPC have tumor testing to see if they would benefit from treatment with a . If you have not had tumor testing or you are unsure if your tumor tissue has been tested, ask your doctor about ordering additional tests. If genetic or tumor testing shows that you have a mutation in , , , ATR, CDK12, , FANCA, , MRE11A, , or , you may benefit from treatment with . If you have a mutation in a different gene, you may still benefit from a or another type of .
If you have not had surgery to remove both testicles ( orchiectomy) you may need to take a drug which blocks testosterone production.
approves with for HRR gene-mutated castration-resistant cancer. news release. June 20, 2023.
Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.
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The following studies are looking at PARP inhibitors and similar agents for treating people with advanced cancer.
- NCT04592237: Chemotherapy, and for the Treatment of Aggressive Variant Cancer. This study will look at how well the combination of chemotherapy drugs (such as cabazitaxel and carboplatin), a PARP inhibitors (), and an agents (cetrelimab) works for treating people with a rare type of cancer known as aggressive variant cancer (AVPC).
- NCT05005728: XmAb®20717 Alone or in Combination With Chemotherapy or in Patients With Castration-Resistant Cancer. This study will look at the safety and clinical activity of the drug XmAb20717 alone or in combination with standard-of-care anticancer therapies in patients with castration-resistant cancer who have been treated with at least 2 prior lines of treatment.
- NCT03317392: Studying the Medication Given with Radium-223 for Advanced Cancer with Bone . This study is measuring the best dosage for and side effects of the drug combination and radium-223 to treat men with mCRPC that has spread to the bones.
Other clinical trials for people with cancer can be found here.
The National Comprehensive Cancer Network has guidelines regarding which cancer patients should undergo genetic counseling and testing. Men with the following factors should speak with a genetics expert about genetic testing:
- A tumor test result that suggests an (for example, a , or mutation in the tumor that may indicate an in one of those genes).
- A blood relative who tested positive for an in a gene linked to cancer.
- cancer diagnosed at any age.
- Intraductal/cribriform cells found by pathology.
- Cancer that is categorized as very high or high risk based on pathology.
- A diagnosis of male breast cancer.
- Eastern European (Ashkenazi) Jewish ancestry.
- One or more first-, second- or third-degree relatives with breast cancer diagnosed at age 50 or younger, or ovarian, pancreatic, male breast cancer, cancer or intraductal/cribriform cancer at any age.
- Two or more close relatives diagnosed with breast or cancer at any age.
The National Comprehensive Cancer Network (NCCN) recommends tumor testing to help guide treatment for people with prostate cancer.
- Testing for MSI-H/dMMR may help identify patients who would benefit from .
- Testing for tumor mutations in HRR genes may help identify patients who would benefit from PARP inhibitors.
- Consider testing for a marker known as (TMB). People with a high (TMB-H) may benefit from .