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TPS5096 : TALAPRO-3 A phase 3, double-blind, randomized study of enzalutamide (ENZA) plus talazoparib (TALA) versus placebo plus ENZA in patients with DDR gene–mutated, metastatic castration-sensitive prostate cancer (mCSPC).

Researchers

Presenter

  • Neeraj Agarwal

Principal Investigators

  • Fred Saad

  • Arun Azad

  • Joaquin Mateo

  • Nobuaki Matsubara

  • Neal D. Shore

  • Jayeta Chakrabarti

  • Hsiang-Chun Chen

  • Silvana Lanzalone

  • Alexander Niyazov

  • Karim Fizazi

Medical Centers

  • Hunstman Cancer Institute of Utah, Salt Lake City, UT

  • University of Montreal Hospital Center, Montreal, QC, Canada

  • Peter MacCallum Cancer Centre, East Melbourne, Australia

  • Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain

  • National Cancer Center Hospital, Tokyo, Japan

  • Carolina Urologic Research Center, Myrtle Beach, SC

  • Pfizer Limited, Surrey, United Kingdom

  • Pfizer Oncology, La Jolla, CA

  • Pfizer Inc, Milan, Italy

  • Pfizer Inc, New York, NY

  • Institut Gustave Roussy, University of Paris Sud, Villejuif, France

Locations

  • United States

  • Canada

  • Australia

  • Spain

  • Japan

  • United Kingdom

  • Italy

  • France

Companies

  • PharmAbcine Inc.

Study Components

Therapeutic Area

  • Blood/haematological Diseases

  • Urology

  • Oncology (ONC)

  • Musculoskeletal

  • Genetic Disorder

Disease

  • Brain metastasis

  • Prostate cancer

  • Solid malignancies

  • Fanconi anemia, complementation group A

  • Short stature, onychodysplasia, facial dysmorphism, and hypotrichosis

Biomarkers

  • Ataxia Telangiectasia And Rad3-Related Protein

  • Breast cancer type 1 susceptibility protein

  • Breast cancer type 2 susceptibility protein

  • MutL Homolog 1

  • Nibrin

  • checkpoint kinase 2

  • Fanconi anaemia, complementation group A

  • Hormone receptor

  • Partner and localizer of BRCA2

  • RAD51 Paralog C

  • Ataxia-telangiectasia mutated

Drug/Treatment

  • Enzalutamide

  • Talazoparib

Outcome

  • N/A


Study Design

  • Randomized

  • Placebo Control

  • Double Blind/Blinded

Phase

  • III

Study Id's

  • NCT04821622

Sponsors

  • N/A

Result

  • N/A