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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) (PRX32)

This study is currently recruiting participants.
Verified December 2017 by University of Florida
Sponsor:
ClinicalTrials.gov Identifier:
NCT03296124
First Posted: September 28, 2017
Last Update Posted: December 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Driver
Information provided by (Responsible Party):
University of Florida
  Purpose
Retrospective Review Study for Prognostic Transcriptional Output Related to Androgen Receptor Expression in Patients Treated for High Risk Prostate Cancer with Proton Therapy

Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Estimated Enrollment: 375
Actual Study Start Date: December 7, 2017
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296124


Contacts
Contact: Intake Coordinator 877-686-6009 lward@floridaproton.org

Locations
United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator    877-686-6009      
Principal Investigator: Curits M Bryant, MD, MPH         
Sponsors and Collaborators
University of Florida
Driver
Investigators
Principal Investigator: Curtis M Bryant, MD, MPH University of Florida Proton Therapy Institute
  More Information

Additional Information:
Publications:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03296124     History of Changes
Other Study ID Numbers: UFPTI 1612- PRX32
IRB201700018 ( Other Identifier: UF IRB )
First Submitted: September 14, 2017
First Posted: September 28, 2017
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Prostate Cancer
Proton Radiation

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs