PARP inhibitors, rucaparib (Rubraca) and olaparib (Lynparza) receive FDA approval for metastatic prostate cancer
The FDA approved two PARP inhibitors, rucaparib (Rubraca) and olaparib (Lynparza) for treatment of metastatic castration-resistant prostate cancer (mCRPC) in men who have certain inherited mutations or tumor mutations. (6/1/20)
The National Comprehensive Cancer Network has guidelines regarding which prostate 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 inherited mutation (for example, a BRCA1, BRCA2 or ATM mutation in the tumor that may indicate an inherited mutation in one of those genes).
- A blood relative who tested positive for an inherited mutation in a gene linked to prostate cancer.
- Metastatic prostate 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, metastatic prostate cancer or intraductal/cribriform prostate cancer at any age.
- Two or more close relatives diagnosed with breast or prostate cancer at any age.
The National Comprehensive Cancer Network (NCCN) recommends tumor testing to help guide treatment for people with metastatic prostate cancer.
- Testing for MSI-H/dMMR may help identify patients who would benefit from immunotherapy.
- Testing for tumor mutations in HRR genes may help identify patients who would benefit from PARP inhibitors.
- Consider testing for a marker known as tumor mutational burden (TMB). People with a high tumor mutational burden (TMB-H) may benefit from immunotherapy.
Questions To Ask Your Health Care Provider
- Am I eligible for treatment with a PARP inhibitor?
- Given my personal or family history, should I have genetic testing for an inherited mutation
- Should I have tumor biomarker testing?
- What are the risk and benefits of taking a PARP inhibitor?
- Will my insurance cover treatment with a PARP inhibitor?
- How much will my treatment cost?
Open Clinical Trials
The following studies are looking at PARP inhibitors and similar agents for treating people with advanced prostate cancer.
Other clinical trials for people with prostate cancer can be found here.
The following studies are looking at treatment for people with advanced solid tumors.
- NCT05252390: NUV-868 Alone and in Combination With PARP Inhibitors in Patients With Advanced Solid Tumors.This study will test the safety and effectiveness of the experimental drug NUV-868 alone and combined with a PARP inhibitor in people with advanced solid tumors. This study is open to people whose cancer stopped responding or progressed on PARP inhibitors.
- NCT05169437: PARP inhibitor (niraparib) in patients with inherited or tumor PALB2 mutations in advanced solid tumors (PAVO). PAVO is a Phase II study investigating if the PARP inhibitor niraparib is safe and effective for people with an advanced solid tumor who have an inherited PALB2 gene mutation or a tumor with a PALB2 mutation.
- NCT02264678: Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents. This is a study of ceralasertib administered orally in combination with chemotherapy regimens and/or novel anticancer agents to patients with advanced cancer. The study is enrolling people with inherited mutations, including BRCA1, BRCA2, ATM, RAD51C, RAD51D, and people with tumors that are HRD-positive.
- NCT04644068: Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (PETRA). This research is designed to learn whether treatment with a new PARP inhibitor, AZD5305, used alone or in combination with anti-cancer agents is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors. The study is open to people who have previously been treated with PARP inhibitors.
- NCT04267939: ATR Inhibitor Plus Niraparib Study in Advanced Solid Tumors and Ovarian Cancer. This study will look at how well people with advanced solid tumors respond to treatment with the targeted therapy BAY1895344 in combination with the PARP inhibitor niraparib. This study is open to people with inherited mutations in ATM, BRCA1, BRCA2 and other genes. Contact the study coordinator for information about eligibility for people with mutations in other genes.
- NCT04657068: Treatment with ATR Inhibitor for Advanced or Metastatic Solid Tumors. This study will look at how well a new oral targeted therapy known as an ATR inhibitor works on advanced or metastatic solid tumors with mutations in genes that are linked to DNA damage repair. This study is open to people who have an inherited or acquired BRCA or ATM mutation or whose tumors are HRD-positive. This study is open to people whose cancer stopped responding or progressed on PARP inhibitors.
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.