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WithdrawnNCT03296124PRX32Updated Nov 16, 2018

Prognostic Value of Androgen Receptor Expression and Mutations Within Oncogenes and Tumor Suppressor Genes in Patients Treated for High Risk Prostate Cancer With Proton Therapy (PRX32)

An observational study in Prostate Cancer, sponsored by University of Florida. Withdrawn at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-16.

Sponsored by University of Florida · Observational

Why this study was withdrawn
This project currently does not have any subjects enrolled due to other PI priorities.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
0
Ages
18 Years and older
Sex
Male
01

Study summary

Retrospective Review Study for Prognostic Transcriptional Output Related to Androgen Receptor Expression in Patients Treated for High Risk Prostate Cancer with Proton Therapy

02

Conditions studied

  • Prostate Cancer

Browse trials for

Keywords

  • Prostate Cancer
  • Proton Radiation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The inclusion (target study population) criteria for this retrospective outcomes analysis are adult patients (older than 18 years at time of treatment) with high risk prostate cancer who were treated with proton therapy at UFHPTI/Department of Radiation Oncology. For this retrospective outcomes study, data will be used from patients treated between 6/10/2010 through 4/26/17 with at least 2 years follow up.

Eligibility criteria

Inclusion Criteria:

  • Adult patients (older than 18 years at time of treatment) with high risk prostate cancer who were treated with proton therapy at UFHPTI/Department of Radiation Oncology
  • Patients treated between 6/10/2010 through 4/26/17 with at least 2 years follow up
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
0 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Immunohistochemistry of tumor cell proteins will be performed on prostate biopsies to detect for androgen receptors and other protein products related to oncogenes or tumor suppressor genes thought to play a role in radiation or ADT.

    Time frame: 2 years follow up

Secondary outcomes

  1. DNA sequencing will be performed on prostate tumor DNA to determine the mutational status of several oncogenes and tumor suppressor genes including genes coding androgen receptors.

    Time frame: 2 years follow up

  2. RNA sequencing will be performed on several oncogenes and tumor suppressor genes including genes coding androgen receptors to detect RNA expression including genes related to the androgen receptor.

    Time frame: 2 years follow up

06

Study locations

1 site
  • University of Florida Proton Therapy Institute
    Jacksonville, Florida 32206, United States
07

References and documents

Publications

  • Roach M 3rd, Bae K, Speight J, Wolkov HB, Rubin P, Lee RJ, Lawton C, Valicenti R, Grignon D, Pilepich MV. Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: long-term results of RTOG 8610. J Clin Oncol. 2008 Feb 1;26(4):585-91. doi: 10.1200/JCO.2007.13.9881. Epub 2008 Jan 2. PubMed 18172188 ↗
  • Denham JW, Steigler A, Lamb DS, Joseph D, Turner S, Matthews J, Atkinson C, North J, Christie D, Spry NA, Tai KH, Wynne C, D'Este C. Short-term neoadjuvant androgen deprivation and radiotherapy for locally advanced prostate cancer: 10-year data from the TROG 96.01 randomised trial. Lancet Oncol. 2011 May;12(5):451-9. doi: 10.1016/S1470-2045(11)70063-8. PubMed 21440505 ↗
  • Sydes MR, Stephens RJ, Moore AR, Aird EG, Bidmead AM, Fallowfield LJ, Graham J, Griffiths S, Mayles WP, McGuire A, Stanley S, Warrington AP, Dearnaley DP; RT01 collaborators. Implementing the UK Medical Research Council (MRC) RT01 trial (ISRCTN 47772397): methods and practicalities of a randomised controlled trial of conformal radiotherapy in men with localised prostate cancer. Radiother Oncol. 2004 Aug;72(2):199-211. doi: 10.1016/j.radonc.2004.04.007. PubMed 15297138 ↗
  • Liauw SL, Weichselbaum RR, Rash C, Correa D, Al-Hallaq HA, Pelizzari CA, Jani AB. Biochemical control and toxicity after intensity-modulated radiation therapy for prostate cancer. Technol Cancer Res Treat. 2009 Jun;8(3):201-6. doi: 10.1177/153303460900800304. PubMed 19445537 ↗
  • D'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW. Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial. JAMA. 2008 Jan 23;299(3):289-95. doi: 10.1001/jama.299.3.289. PubMed 18212313 ↗
  • Christensen M, Najy AJ, Snyder M, Movilla LS, Kim HR. A critical role of the PTEN/PDGF signaling network for the regulation of radiosensitivity in adenocarcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2014 Jan 1;88(1):151-8. doi: 10.1016/j.ijrobp.2013.10.019. PubMed 24331662 ↗
  • Paximadis P, Najy AJ, Snyder M, Kim HR. The interaction between androgen receptor and PDGF-D in the radiation response of prostate carcinoma. Prostate. 2016 May;76(6):534-42. doi: 10.1002/pros.23135. Epub 2016 Jan 6. PubMed 26732854 ↗
  • Mettlin CJ, Murphy GP, Rosenthal DS, Menck HR. The National Cancer Data Base report on prostate carcinoma after the peak in incidence rates in the U.S. The American College of Surgeons Commission on Cancer and the American Cancer Society. Cancer. 1998 Oct 15;83(8):1679-84. doi: 10.1002/(sici)1097-0142(19981015)83:83.0.co;2-y. PubMed 9781963 ↗
  • Spratt DE, Pei X, Yamada J, Kollmeier MA, Cox B, Zelefsky MJ. Long-term survival and toxicity in patients treated with high-dose intensity modulated radiation therapy for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2013 Mar 1;85(3):686-92. doi: 10.1016/j.ijrobp.2012.05.023. Epub 2012 Jul 12. PubMed 22795805 ↗
  • Vora SA, Wong WW, Schild SE, Ezzell GA, Andrews PE, Ferrigni RG, Swanson SK. Outcome and toxicity for patients treated with intensity modulated radiation therapy for localized prostate cancer. J Urol. 2013 Aug;190(2):521-6. doi: 10.1016/j.juro.2013.02.012. Epub 2013 Feb 13. PubMed 23415964 ↗
  • Horwitz EM, Bae K, Hanks GE, Porter A, Grignon DJ, Brereton HD, Venkatesan V, Lawton CA, Rosenthal SA, Sandler HM, Shipley WU. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008 May 20;26(15):2497-504. doi: 10.1200/JCO.2007.14.9021. Epub 2008 Apr 14. PubMed 18413638 ↗
  • Bartek J, Mistrik M, Bartkova J. Androgen receptor signaling fuels DNA repair and radioresistance in prostate cancer. Cancer Discov. 2013 Nov;3(11):1222-4. doi: 10.1158/2159-8290.CD-13-0679. PubMed 24203954 ↗
  • Polkinghorn WR, Parker JS, Lee MX, Kass EM, Spratt DE, Iaquinta PJ, Arora VK, Yen WF, Cai L, Zheng D, Carver BS, Chen Y, Watson PA, Shah NP, Fujisawa S, Goglia AG, Gopalan A, Hieronymus H, Wongvipat J, Scardino PT, Zelefsky MJ, Jasin M, Chaudhuri J, Powell SN, Sawyers CL. Androgen receptor signaling regulates DNA repair in prostate cancers. Cancer Discov. 2013 Nov;3(11):1245-53. doi: 10.1158/2159-8290.CD-13-0172. Epub 2013 Sep 11. PubMed 24027196 ↗
  • Raghu D, Paul PJ, Gulati T, Deb S, Khoo C, Russo A, Gallo E, Blandino G, Chan AL, Takano E, Sandhu SK, Fox SB, Williams S, Haupt S, Gamell C, Haupt Y. E6AP promotes prostate cancer by reducing p27 expression. Oncotarget. 2017 Jun 27;8(26):42939-42948. doi: 10.18632/oncotarget.17224. PubMed 28477016 ↗
  • Malla B, Zaugg K, Vassella E, Aebersold DM, Dal Pra A. Exosomes and Exosomal MicroRNAs in Prostate Cancer Radiation Therapy. Int J Radiat Oncol Biol Phys. 2017 Aug 1;98(5):982-995. doi: 10.1016/j.ijrobp.2017.03.031. Epub 2017 Mar 27. PubMed 28721912 ↗
  • Bostrom PJ, Bjartell AS, Catto JW, Eggener SE, Lilja H, Loeb S, Schalken J, Schlomm T, Cooperberg MR. Genomic Predictors of Outcome in Prostate Cancer. Eur Urol. 2015 Dec;68(6):1033-44. doi: 10.1016/j.eururo.2015.04.008. Epub 2015 Apr 23. PubMed 25913390 ↗
  • Choudhury AD, Eeles R, Freedland SJ, Isaacs WB, Pomerantz MM, Schalken JA, Tammela TL, Visakorpi T. The role of genetic markers in the management of prostate cancer. Eur Urol. 2012 Oct;62(4):577-87. doi: 10.1016/j.eururo.2012.05.054. Epub 2012 Jun 5. PubMed 22695242 ↗

Individual participant data

Plan to share: No — The collection of sensitive information about subjects is limited to the amount necessary to achieve the aims of the research, so that no unneeded sensitive information is being collected.

08

Registry details

Key details

Study ID
NCT03296124
Lead sponsor
University of Florida
Collaborators
Driver
Responsible party
Sponsor
First posted
Sep 28, 2017
Start date
Dec 7, 2017
Primary completion
Sep 2020 (estimated)
Completion
Sep 2020 (estimated)
Last update
Nov 16, 2018

Study contacts

Curtis M Bryant, MD, MPH
principal investigator · University of Florida Proton Therapy Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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