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)

Prostate Cancer Clinical Trial

— PRX32  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03296124
• Other study ID #: UFPTI 1612- PRX32
• Secondary ID: IRB201700018
• Status: Withdrawn
• Start date: December 7, 2017
• Est. completion date: September 2020

Study information

• Verified date: November 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	University of Florida Proton Therapy Institute	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Driver

Country where clinical trial is conducted

United States, 

References & Publications (17)

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. — View Citation

Boström 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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years follow up
Secondary	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.		2 years follow up
Secondary	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.		2 years follow up

External Links

•   Cancer Facts & Figures 2017. 2017. Atlanta, GA: American Cancer Society.
•   NCCN Guidelines for Patients: Prostate Cancer, version 1. 2015. Fort Washington, PA: National Comprehensive Cancer Network.