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A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients with Metastatic Castration-Resistant Prostate Cancer with DNA Repair Defects
The purpose of this research is to study two U.S. Food and Drug Administration (FDA) approved drugs alone and in combination with each other in people who have mCRPC and DNA repair defects.
Primary Objective: Evaluate the objective PFS of abiraterone/prednisone, olaparib or the combination abiraterone/prednisone + olaparib in mCRPC patients with canonical DNA repair defects in BRCA1, BRCA2, or ATM. Secondary Objectives: To evaluate: - Measurable disease response rate by RECIST. - Whether noncanonical DNA repair defects in FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2, GEN1, MSH2, MSH6, BRIP1, or FAM175A have clinical susceptibility to PARP inhibition alone. - The safety of the combination of abiraterone/prednisone and olaparib combination therapy. - The response rate and PFS with cross over to olaparib or abiraterone post progression on therapy with abiraterone or olaparib respectively. - The qualitative and quantitative toxicities. Correlative Objectives: - CTC number, morphology and possible DNA, RNA analyses will assess for heterogeneity, mutational load, DNA repair defects, and expression of key prostate cancer-related genes for potential use as biomarkers of response or failure and also as a potential surrogate for the metastatic biopsy. - ctDNA will be assessed for mutational load as a biomarker of response or failure and also as a means to identify DNA repair defects for use as a potential surrogate for the metastatic biopsy. - Correlation of mutational data, copy number alterations, and transcriptome profiling between liquid assays and tissue-based analyses. - Within the above data sets and also the sequencing of the metastatic biopsy, the predictive and prognostic role of AR mutations, amplifications, splice variants, expression regulation, and other androgen signaling pathway modulation. - IHC or other genetic/proteomic/methylomic analyses in the future may be pursued as excess samples will be banked.
Abiraterone acetate (); Olaparib (Lynparza); Zytiga (Abiraterone acetate); prednisone ()
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