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 of Prostate Cancer, run by University of Florida at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

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 Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 7 Dec 2017to Sep 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206

Other trials in United States

About this study

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

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

Conditions: Prostate Cancer
Keywords: Prostate Cancer, Proton Radiation
Medical subject headings: Prostatic Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 years follow up

Secondary outcomes (2)

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.
Measured: 2 years follow up
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.
Measured: 2 years follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Dec 2017Sep 2020

First posted28 Sep 2017
Study start7 Dec 2017
Primary completionSep 2020 (estimated)
Study completionSep 2020 (estimated)

Why it stopped: This project currently does not have any subjects enrolled due to other PI priorities.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03296124
Sponsor's protocol ID: UFPTI 1612- PRX32
Other IDs: IRB201700018
Acronym: PRX32
Status last verified: Nov 2018
First submitted: 14 Sep 2017
Last updated: 16 Nov 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma

All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03296124
Acronym / sponsor ID: PRX32 / UFPTI 1612- PRX32
Conditions: Prostate Cancer
Keywords: Prostate Cancer, Proton Radiation
Study type: Observational
Recruitment status: WithdrawnReason stopped: This project currently does not have any subjects enrolled due to other PI priorities.
Enrolment: 0 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: Driver
Study start: 7 Dec 2017 (actual)
Primary completion: Sep 2020 (estimated)
Study completion: Sep 2020 (estimated)
First posted: 28 Sep 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

2 secondary outcomes

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
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

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
Background: PubMed 18172188Roach 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.
Background: PubMed 21440505Denham 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.
Background: PubMed 15297138Sydes 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.
Background: PubMed 19445537Liauw 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.
Background: PubMed 18212313D'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.
Background: PubMed 24331662Christensen 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.
Background: PubMed 26732854Paximadis 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.
Background: PubMed 9781963Mettlin 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.
Background: PubMed 22795805Spratt 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.
Background: PubMed 23415964Vora 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.
Background: PubMed 18413638Horwitz 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.
Background: PubMed 24203954Bartek 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.
Cancer Facts \& Figures 2017. 2017. Atlanta, GA: American Cancer Society.Link provided by the sponsor.
Individual participant dataSharing planned: 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.

Related trials for Prostate Cancer

RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Curtis M Bryant, MD, MPH principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03296124, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018; AzTrials last refreshed its copy on 1 Nov 2026.