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)

NCT03296124 | Withdrawn

• 2 other identifiers: UFPTI 1612- PRX32IRB201700018
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

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.

  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.

  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.

  2 years follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Driver: collaborator

Study Sites (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

Related Publications (17)

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Related Links

• Cancer Facts \& Figures 2017. 2017. Atlanta, GA: American Cancer Society.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Curtis M Bryant, MD, MPH

  University of Florida Proton Therapy Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 28, 2017
• Study Start: December 7, 2017
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 16, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)