Evaluation of Intense Androgen Deprivation Before Prostatectomy: A Randomized Phase II Trial of Enzalutamide and Leuprolide With or Without Abiraterone

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Rana R McKayMary-Ellen Taplin

Abstract

Patients with locally advanced prostate cancer have an increased risk of cancer recurrence and mortality. In this phase II trial, we evaluate neoadjuvant enzalutamide and leuprolide (EL) with or without abiraterone and prednisone (ELAP) before radical prostatectomy (RP) in men with locally advanced prostate cancer. Eligible patients had a biopsy Gleason score of 4 + 3 = 7 or greater, prostate-specific antigen (PSA) greater than 20 ng/mL, or T3 disease (by prostate magnetic resonance imaging). Lymph nodes were required to be smaller than 20 mm. Patients were randomly assigned 2:1 to ELAP or EL for 24 weeks followed by RP. All specimens underwent central pathology review. The primary end point was pathologic complete response or minimal residual disease (residual tumor ≤ 5 mm). Secondary end points were PSA, surgical staging, positive margins, and safety. Biomarkers associated with pathologic outcomes were explored. Seventy-five patients were enrolled at four centers. Most patients had high-risk disease by National Comprehensive Cancer Network criteria (n = 65; 87%). The pathologic complete response or minimal residual disease rate was 30% (n = 15 of 50) in ELAP-treated patients and 16% (n = four of 25) in EL-treated patients (tw...Continue Reading

Associated Clinical Trials

Oct 20, 2014·Mary-Ellen Taplin, MDMary-Ellen Taplin, MD

References

Mar 23, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Adam C BergerMelvyn Goldberg
Sep 6, 2007·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·W Fraser SymmansLajos Pusztai
Feb 9, 2008·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Priya RastogiNorman Wolmark
Jul 29, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Andrew J StephensonPeter T Scardino
Jan 18, 2011·The Journal of Urology·Scott E EggenerAndrew J Stephenson
May 27, 2011·The New England Journal of Medicine·Johann S de BonoUNKNOWN COU-AA-301 Investigators
Jan 24, 2012·Cancer Research·Nicola J CleggJeffrey H Hager
Dec 12, 2012·The New England Journal of Medicine·Charles J RyanUNKNOWN COU-AA-302 Investigators
Dec 11, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Elahe A MostaghelBruce Montgomery
Jun 3, 2014·The New England Journal of Medicine·Tomasz M BeerUNKNOWN PREVAIL Investigators
Sep 11, 2014·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Laleh Amiri-KordestaniPatricia Cortazar
Oct 15, 2014·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Mary-Ellen TaplinPhilip W Kantoff
Feb 6, 2017·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Bruce MontgomeryMary-Ellen Taplin
Aug 11, 2017·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Wanling XieUNKNOWN ICECaP Working Group
Jul 16, 2015·Cell·Dan RobinsonArul M Chinnaiyan

❮ Previous
Next ❯

Citations

Jun 1, 2019·International Braz J Urol : Official Journal of the Brazilian Society of Urology·Leonardo O ReisQuoc-Dien Trinh
Jan 25, 2020·The Cancer Journal·Stephen T RyanRana R McKay
Apr 8, 2020·AJR. American Journal of Roentgenology·Stephanie M WalkerBaris Turkbey
Jul 25, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·James A EasthamMichael J Morris
Jun 18, 2020·International Braz J Urol : Official Journal of the Brazilian Society of Urology·Lara Rodriguez SanchezRafael Sanchez-Salas
Feb 15, 2020·Nature Communications·Scott WilkinsonAdam G Sowalsky
Nov 24, 2020·Expert Review of Anticancer Therapy·Lisa MorisSteven Joniau
Dec 7, 2020·European Urology·Weranja RanasingheBrian F Chapin
Oct 8, 2020·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Fatima KarzaiWilliam L Dahut
Feb 20, 2021·Prostate Cancer and Prostatic Diseases·Daniel E SprattKara Olivier
Apr 24, 2020·Biochimica Et Biophysica Acta. Reviews on Cancer·Bing GaoJianping Guo
Apr 8, 2021·Nature Reviews. Urology·Weranja RanasingheBrian F Chapin

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.