Treating Metastatic Prostate Cancer with Chemotherapy or PARP Inhibitor in People with Mutations (COBRA)

https://www.facingourrisk.org/research-clinical-trials/study/210/treating-metastatic-prostate-cancer-with-chemotherapy-or-parp-inhibitor-in-people-with-mutations-cobra

Clinicaltrials.gov identifier:
NCT04038502 (https://clinicaltrials.gov/show/NCT04038502)

Treatment
Treatment study for mCRPC with an inherited or tumor mutation in BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2, RAD51B, RAD51C, RAD51D or RAD54L

Study Contact Information:

For additional information, please contact:

Robert B Montgomery, MD by phone: 206-277-6878 or by email: Robert.Montgomery@va.gov
Makayla L DeJong by phone: (206) 277-4527 or by email: Makayla.Dejong@va.gov

About the Study

This study is comparing carboplatin chemotherapy to the drug, olaparib (a type of targeted therapy) 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 inherited mutation found through genetic testing, or tumor mutation found through biomarker testing.

What the Study Involves

Participants will be assigned to one of two different groups, and both the participant and their doctors will know which treatment they are receiving.

Group 1 will receive intravenous chemotherapy (carboplatin) every 21 days, until they can no longer tolerate the treatment, their tumor has a complete response to the treatment, or their tumor grows and their cancer gets worse on the treatment. At this point in the study participants will be allowed to "crossover" to the other group (Group 2) and will receive the targeted therapy olaparib twice daily by mouth until they can no longer tolerate the treatment, or their disease gets worse, whichever is first.
Group 2 will receive Olaparib taken twice daily by mouth, until they can no longer tolerate the treatment, their tumor has a complete response to the treatment, or their tumor grows or their cancer gets worse on the treatment. At this point, they will be allowed to "crossover" to Group 1 and receive intravenous carboplatin every 21 days, until they can no longer tolerate the treatment, or their disease progresses, whichever is first.

Participants can crossover to the other therapy as long as they still meet inclusion criteria and it has been 3 weeks since their last treatment of either carboplatin or olaparib. Throughout the study, safety and the ability of participants to tolerate the treatment will be measured.

This Study is Open To:

Men 18 years or older with the following may be able to participate:

have a diagnosis of metastatic castration resistant prostate cancer
are on androgen-deprivation therapy or have had an orchiectomy
have had previous testing which confirms inherited or tumor BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2, RAD51B, RAD51C, RAD51D or RAD54L mutation
have received prior treatment with abiraterone acetate, enzalutamide, apalutamide or darolutamide

This Study is Not Open To:

Men with the following may not participate:

are participating in another clinical trial or being treated for other cancers
have been treated for mCRPC with platinum, mitoxantrone, or a PARP inhibitor
have a diagnosis of small cell carcinoma
have leukemia or myelodysplastic syndrome
have heart disease, dementia, other psychiatric disorders

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.