News from the FDA: Updates on metastatic prostate cancer treatment
https://www.facingourrisk.org/XRAY/FDA-approves-new-metastatic-prostate-cancer-treatments
Full article: https://www.fda.gov/
This update highlights recent FDA approvals and expanded uses for three drugs related to metastatic prostate cancer treatment. These updates affect how prostate cancer may be found and treated, including new options that may allow some men with advanced prostate cancer to delay or avoid chemotherapy. Overall, these updates may provide more choices for people with metastatic castration-resistant prostate cancer (mCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). (posted 2/13/26)
Questions To Ask Your Health Care Provider
General questions for people with prostate cancer:
- Is my prostate cancer metastatic?
- Is my prostate cancer castration-sensitive or castration-resistant?
For metastatic prostate cancer:
- Has my cancer been tested for biomarkers? If so, what were the results? If not, is there any benefit to biomarker testing now?
- Does my tumor have a BRCA2 mutation?
- Is Akeega a good treatment option for me?
- Is Nubeqa (darolutamide) with hormone therapy a good option for me?
- What side effects should I expect from treatment, and how can I manage them?
- How long might this treatment keep my cancer under control?
For metastatic castration-resistant prostate cancer:
- Am I a candidate for Pluvicto based on my PSMA status and previous treatments?
- How does Pluvicto fit with my current therapy plan?
- What side effects should I expect, and how can they be managed?
- How often will I receive treatment, and how will my response be monitored?
Open Clinical Trials
The following treatment studies are enrolling people with advanced prostate cancer:
- NCT05011383: High Dose Testosterone Treatment for People with Metastatic Prostate Cancer and an ATM, CDK12 or CHEK2 Mutation. This study will examine how well an increased dose of testosterone treatment works for people with metastatic castration-resistant prostate cancer (mCRPC) with an ATM, CDK12, or CHEK2 genetic mutation.
- NCT05367440: Treating Metastatic Prostate Cancer with a New PARP Inhibitor AZD5305 Combined With Hormone Therapy. This study will look at the effectiveness of a new PARP inhibitor drug called AZD5305 in combination with different hormone therapies to treat metastatic prostate cancer, compared to the current standard treatment.
- NCT04038502: Treating Metastatic Prostate Cancer with Chemotherapy or PARP Inhibitor in People with Mutations (COBRA). This study is comparing carboplatin chemotherapy to the PARP inhibitor, olaparib as first-line treatment for metastatic castration-resistant prostate cancer in people with a BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2, RAD51B, RAD51C, RAD51D or RAD54L mutation.
- NCT06120491: Studying the Effectiveness of New PARP Inhibitor, Saruparib Compared to Current Treatment Options for Metastatic Prostate Cancer EvoPAR-PRO1. This study will evaluate an investigational PARP inhibitor drug called Saruparib in combination with new hormonal agents to treat metastatic prostate cancer compared to standard treatment in people whose tumors have a mutation in: BRCA1, BRCA2, ATM, BARD1, CDK12, PALB2, RAD51B, RAD51C, or RAD51D.
- NCT03460977: Metastatic Castration Resistant Prostate Cancer Clinical Trial. The purpose of this study is to learn about the safety and effects of the study medicine (called Mevrometostat) for the possible treatment of Castration Resistant Prostate Cancer (CRPC)
The following studies are enrolling people with advanced solid tumors, including prostate cancer:
- NCT06545942: Treating Advanced Cancers with BRCA or Other Related Gene Mutations Using Targeted Therapy MOMA-313 Alone or In Combination with the PARP Inhibitor Olaparib. This trial will study MOMA-313 given alone or together with a PARP inhibitor (olaparib) in people with certain advanced or metastatic cancers with the following mutations: ATM, BRCA1, BRCA2, BRIP1, BARD1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, and/or RAD54L.
- NCT05932862: Study of a New InvestigationaI Inhibitor to Treat People with Advanced Solid Tumors. The study examines the safety and effectiveness of the investigational treatment XL309 when used alone or in combination with a PARP inhibitor to treat people with some advanced solid tumors, including prostate cancer.
- NCT05417594: Study of the PARP inhibitor AZD9574 Alone and Combined with Other Cancer Medicines to Treat People with Advanced Solid Cancers (CERTIS1 Study). This study looks at a new PARP inhibitor AZD9574 given alone and in combination with other anti-cancer drugs for people with advanced cancer that has come back or progressed.
Other clinical trials for people with prostate cancer can be found here.
About FORCE
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.