Literature DB >> 19213669

Department of Defense prostate cancer clinical trials consortium: a new instrument for prostate cancer clinical research.

Michael J Morris1, Ethan M Basch, George Wilding, Maha Hussain, Michael A Carducci, Celestia Higano, Philip Kantoff, William K Oh, Eric J Small, Daniel George, Paul Mathew, Tomasz M Beer, Susan F Slovin, Charles Ryan, Christopher Logothetis, Howard I Scher.   

Abstract

BACKGROUND: In 2005, the US Department of Defense, through the US Army Medical Research and Materiel Command, Office of the Congressionally Directed Medical Research Programs, created a funding mechanism to form a clinical trials consortium to conduct phase I and II studies in prostate cancer. This is the first report of the Prostate Cancer Clinical Trials Consortium (PCCTC). PATIENTS AND METHODS: The Department of Defense award supports a consortium of 10 prostate cancer research centers. Memorial Sloan-Kettering Cancer Center was awarded the Coordinating Center grant for the consortium and charged with creating an infrastructure to conduct early-phase multicenter clinical trials. Each participating center was required to introduce >or=1 clinical trial per year and maintain accrual of a minimum of 35 patients per year.
RESULTS: The PCCTC was launched in 2006 and now encompasses 10 leading prostate cancer research centers. Fifty-one trials have been opened, and 1386 patients have been accrued at member sites. Members share an online clinical trial management system for protocol tracking, electronic data capture, and data storage. A legal framework has been instituted, and standard operating procedures, an administrative structure, editorial support, centralized budgeting, and mechanisms for scientific review are established.
CONCLUSION: The PCCTC fulfills a congressional directive to create a clinical trials instrument dedicated to early-phase prostate cancer studies. The member institutions have built an administrative, informatics, legal, financial, statistical, and scientific infrastructure to support this endeavor. Clinical trials are open and accruing in excess of federally mandated goals.

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Year:  2009        PMID: 19213669      PMCID: PMC3394090          DOI: 10.3816/CGC.2009.n.009

Source DB:  PubMed          Journal:  Clin Genitourin Cancer        ISSN: 1558-7673            Impact factor:   2.872


  8 in total

1.  Clinical states in prostate cancer: toward a dynamic model of disease progression.

Authors:  H I Scher; G Heller
Journal:  Urology       Date:  2000-03       Impact factor: 2.649

2.  Apples and oranges: building a consensus for standardized eligibility criteria and end points in prostate cancer clinical trials.

Authors:  N A Dawson
Journal:  J Clin Oncol       Date:  1998-10       Impact factor: 44.544

3.  Patient online self-reporting of toxicity symptoms during chemotherapy.

Authors:  Ethan Basch; David Artz; Dorothy Dulko; Kevin Scher; Paul Sabbatini; Martee Hensley; Nandita Mitra; John Speakman; Mary McCabe; Deborah Schrag
Journal:  J Clin Oncol       Date:  2005-05-20       Impact factor: 44.544

4.  Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group.

Authors:  G J Bubley; M Carducci; W Dahut; N Dawson; D Daliani; M Eisenberger; W D Figg; B Freidlin; S Halabi; G Hudes; M Hussain; R Kaplan; C Myers; W Oh; D P Petrylak; E Reed; B Roth; O Sartor; H Scher; J Simons; V Sinibaldi; E J Small; M R Smith; D L Trump; G Wilding
Journal:  J Clin Oncol       Date:  1999-11       Impact factor: 44.544

Review 5.  Prostate cancer clinical trial end points: "RECIST"ing a step backwards.

Authors:  Howard I Scher; Michael J Morris; William K Kelly; Lawrence H Schwartz; Glenn Heller
Journal:  Clin Cancer Res       Date:  2005-07-15       Impact factor: 12.531

Review 6.  Clinical trials in relapsed prostate cancer: defining the target.

Authors:  H I Scher; M Mazumdar; W K Kelly
Journal:  J Natl Cancer Inst       Date:  1996-11-20       Impact factor: 13.506

7.  Eligibility and outcomes reporting guidelines for clinical trials for patients in the state of a rising prostate-specific antigen: recommendations from the Prostate-Specific Antigen Working Group.

Authors:  Howard I Scher; Mario Eisenberger; Anthony V D'Amico; Susan Halabi; Eric J Small; Michael Morris; Michael W Kattan; Mack Roach; Philip Kantoff; Kenneth J Pienta; Michael A Carducci; David Agus; Susan F Slovin; Glenn Heller; William Kevin Kelly; Paul H Lange; Daniel Petrylak; William Berg; Celestra Higano; George Wilding; Judd W Moul; Alan N Partin; Christopher Logothetis; Howard R Soule
Journal:  J Clin Oncol       Date:  2004-02-01       Impact factor: 44.544

8.  Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group.

Authors:  Howard I Scher; Susan Halabi; Ian Tannock; Michael Morris; Cora N Sternberg; Michael A Carducci; Mario A Eisenberger; Celestia Higano; Glenn J Bubley; Robert Dreicer; Daniel Petrylak; Philip Kantoff; Ethan Basch; William Kevin Kelly; William D Figg; Eric J Small; Tomasz M Beer; George Wilding; Alison Martin; Maha Hussain
Journal:  J Clin Oncol       Date:  2008-03-01       Impact factor: 44.544

  8 in total
  9 in total

1.  Phase 2 study of neoadjuvant docetaxel plus bevacizumab in patients with high-risk localized prostate cancer: a Prostate Cancer Clinical Trials Consortium trial.

Authors:  Robert W Ross; Matthew D Galsky; Phil Febbo; Marc Barry; Jerome P Richie; Wanling Xie; Fiona M Fennessy; Rupal S Bhatt; Julia Hayes; Toni K Choueiri; Clare M Tempany; Philip W Kantoff; Mary E Taplin; William K Oh
Journal:  Cancer       Date:  2012-01-26       Impact factor: 6.860

2.  Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1-2 study.

Authors:  Howard I Scher; Tomasz M Beer; Celestia S Higano; Aseem Anand; Mary-Ellen Taplin; Eleni Efstathiou; Dana Rathkopf; Julia Shelkey; Evan Y Yu; Joshi Alumkal; David Hung; Mohammad Hirmand; Lynn Seely; Michael J Morris; Daniel C Danila; John Humm; Steve Larson; Martin Fleisher; Charles L Sawyers
Journal:  Lancet       Date:  2010-04-14       Impact factor: 79.321

3.  Developing imaging strategies for castration resistant prostate cancer.

Authors:  Josef J Fox; Michael J Morris; Steven M Larson; Heiko Schöder; Howard I Scher
Journal:  Acta Oncol       Date:  2011-06       Impact factor: 4.089

4.  A phase 2 study of KX2-391, an oral inhibitor of Src kinase and tubulin polymerization, in men with bone-metastatic castration-resistant prostate cancer.

Authors:  Emmanuel S Antonarakis; Elisabeth I Heath; Edwin M Posadas; Evan Y Yu; Michael R Harrison; Justine Y Bruce; Steve Y Cho; Gregory E Wilding; Gerald J Fetterly; David G Hangauer; Min-Fun R Kwan; Lyn M Dyster; Michael A Carducci
Journal:  Cancer Chemother Pharmacol       Date:  2013-01-13       Impact factor: 3.333

5.  Repurposing itraconazole as a treatment for advanced prostate cancer: a noncomparative randomized phase II trial in men with metastatic castration-resistant prostate cancer.

Authors:  Emmanuel S Antonarakis; Elisabeth I Heath; David C Smith; Dana Rathkopf; Amanda L Blackford; Daniel C Danila; Serina King; Anja Frost; A Seun Ajiboye; Ming Zhao; Janet Mendonca; Sushant K Kachhap; Michelle A Rudek; Michael A Carducci
Journal:  Oncologist       Date:  2013-01-22

6.  Circulating Tumor Cell Chromosomal Instability and Neuroendocrine Phenotype by Immunomorphology and Poor Outcomes in Men with mCRPC Treated with Abiraterone or Enzalutamide.

Authors:  Landon C Brown; Susan Halabi; Joseph D Schonhoft; Qian Yang; Jun Luo; David M Nanus; Paraskevi Giannakakou; Russell Z Szmulewitz; Daniel C Danila; Ethan S Barnett; Emily A Carbone; Jimmy L Zhao; Patrick Healy; Monika Anand; Audrey Gill; Adam Jendrisak; William R Berry; Santosh Gupta; Simon G Gregory; Richard Wenstrup; Emmanuel S Antonarakis; Daniel J George; Howard I Scher; Andrew J Armstrong
Journal:  Clin Cancer Res       Date:  2021-04-05       Impact factor: 13.801

Review 7.  Prostate Cancer Disparity, Chemoprevention, and Treatment by Specific Medicinal Plants.

Authors:  Clement G Yedjou; Ariane T Mbemi; Felicite Noubissi; Solange S Tchounwou; Nole Tsabang; Marinelle Payton; Lucio Miele; Paul B Tchounwou
Journal:  Nutrients       Date:  2019-02-04       Impact factor: 5.717

8.  Prospective Multicenter Validation of Androgen Receptor Splice Variant 7 and Hormone Therapy Resistance in High-Risk Castration-Resistant Prostate Cancer: The PROPHECY Study.

Authors:  Andrew J Armstrong; Susan Halabi; Jun Luo; David M Nanus; Paraskevi Giannakakou; Russell Z Szmulewitz; Daniel C Danila; Patrick Healy; Monika Anand; Colin J Rothwell; Julia Rasmussen; Blair Thornburg; William R Berry; Rhonda S Wilder; Changxue Lu; Yan Chen; John L Silberstein; Gabor Kemeny; Giuseppe Galletti; Jason A Somarelli; Santosh Gupta; Simon G Gregory; Howard I Scher; Ryan Dittamore; Scott T Tagawa; Emmanuel S Antonarakis; Daniel J George
Journal:  J Clin Oncol       Date:  2019-03-13       Impact factor: 44.544

9.  Prospective Multicenter Study of Circulating Tumor Cell AR-V7 and Taxane Versus Hormonal Treatment Outcomes in Metastatic Castration-Resistant Prostate Cancer.

Authors:  Andrew J Armstrong; Jun Luo; David M Nanus; Paraskevi Giannakakou; Russell Z Szmulewitz; Daniel C Danila; Patrick Healy; Monika Anand; William R Berry; Tian Zhang; Michael R Harrison; Changxue Lu; Yan Chen; Giuseppe Galletti; Joseph D Schonhoft; Howard I Scher; Richard Wenstrup; Scott T Tagawa; Emmanuel S Antonarakis; Daniel J George; Susan Halabi
Journal:  JCO Precis Oncol       Date:  2020-10-28
  9 in total

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