| AVAILABLE FOR DOWNLOAD: APCCC PRESENTER SLIDES |
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| FDA Announces Breakthrough Designation Granted to Niraparib for the Treatment of Metastatic Castration-Resistant Prostate Cancer
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| The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for niraparib, an orally-administered poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have received prior taxane chemotherapy and androgen receptor (AR)-targeted therapy. A Breakthrough Therapy Designation is granted to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
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STATE-OF-THE-INDUSTRY VIDEOS BY LEADING UROLOGY EXPERTS |
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| Genetic Counseling in Prostate Cancer
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| Brittany Szymaniak, Ph.D., CGC
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| Alicia Morgans discusses genetic counseling in GU cancers with Brittany Szymaniak. This conversation includes the challenges, the benefits, the concerns of genetic testing and how this is accomplished in clinical practice for people who have genital urinary malignancies, so prostate cancer, bladder cancer, kidney cancer.
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Integrating Genomics and Genetics into Clinical Care for Prostate Cancer, A Pathologist's Perspective - Colin Pritchard
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| In the era that genomics and genetics are really making an impact to clinical practice and with the recent positive results of the PROfound study, Alicia Morgans and Colin Pritchard have a discussion thinking about this data, how do we implement it, and how do we work with our pathologists to make things happen?
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Genetic Risk in Prostate Cancer - Jacob Berchuck & Mary-Ellen Taplin
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| Jacob Berchuck and Mary-Ellen Taplin join Alicia Morgans in discussing areas of genetic risk in high-risk localized prostate cancer. They discuss the complexity of screening patients and incorporating the identifying of patients for genetic risk into clinical workflow.
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EDITOR SELECTED ABSTRACTS AND COMMENTARIES |
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Risk Prediction Tools Available for Germline BRCA1/2 Mutations Underperform in Prostate Cancer Patients - Beyond the Abstract
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Elena Castro, MD, PhD
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| Robinson et al. were the first to report in 2015 that germline mutations in DNA damage repair (DDR) genes are more common in advanced prostate cancer than previously considered. Pritchard et al identified inheritable mutations in genes related to cancer-predisposition syndromes in 12% of metastatic prostate cancer patients, and a significant proportion of them did not have a previous family history of cancer to suspect the presence of these genetic variants.
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RECENT DATA FROM CONFERENCES WORLDWIDE |
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| GALAHAD - A Phase 2 Study of Niraparib in Patients with mCRPC and Biallelic DNA-Repair Gene Defects, A Pre-Specified Interim Analysis
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| Matthew R. Smith, MD, Ph.D
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| Patients with mCRPC and disease progression after AR targeted therapy and taxane-based chemotherapy have a poor prognosis and few options for treatment. Preliminary evidence suggests that PARP inhibition is effective for patients with mCRPC and DNA repair defects.
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| CDK12-Altered Prostate Cancer: Clinical Features and Therapeutic Outcomes to Standard Systemic Therapies, PARP and PD1 Inhibitors.
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| Emmanuel Antonarakis, MBBCh
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| Emmanuel Antonarakis presented a multicenter study to identify advanced prostate cancer patients with loss-of-function CDK12 alterations. They then characterized the clinical features and therapeutic outcomes of these patients, including sensitivity to PARP and PD1 inhibitors.
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| Preliminary Results from the TRITON2 Study of Rucaparib in Patients with DNA Damage Repair-deficient mCRPC: Updated Analyses
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| Wassim Abida, MD, PhD
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| Rucaparib is a PARP inhibitor and has shown antitumor activity in patients with mCRPC and a deleterious DNA damage repair-deficient gene alteration. Initial results from the phase II TRITON2 study evaluating rucaparib in men who have progressed on an androgen receptor directed therapy and chemotherapy demonstrated confirmed radiographic and PSA responses in 44.0% and 51.1% of patients with a deleterious BRCA1/2 alteration, initially presented at ESMO 2018
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| Invited Discussant: (LBA50, 845PD, 846PD and 847PD) Phase 2 Study GALAHAD, CDK12-altered Prostate Cancer, Preliminary results from the TRITON2 study, and HRRm in Tumor Tissue from men with mCRPC Screened for the PROfound Study
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| Elena Castro, MD, PhD
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| Dr. Elena Castro discussed four prostate cancer abstracts: Pre-specified interim analysis of GALAHAD: a phase 2 study of niraparib in patients with metastatic castration-resistant prostate cancer and biallelic DNA-repair gene defects, CKD12-altered prostate cancer: Clinical features and therapeutic outcomes to standard systemic therapies, PARP inhibitors, and PD1 inhibitors (Emmanuel S. Antonarakis) Preliminary results from the TRITON2 study (NCT02952534) of rucaparib in patients with DNA damage-repair deficient metastatic castration-resistant prostate cancer: updated analysis (Wasim Abida) Central, prospective detection of homologous recombination repair gene mutations in tumor tissue from >4000 men with metastatic castration-resistant prostate cancer screened for the PROfound study (NCT02987543) (Johann S. De Bono)
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