ClinicalTrials.gov
ClinicalTrials.gov Menu

Prostate Metabolomic Study

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01968538
Recruitment Status : Enrolling by invitation
First Posted : October 24, 2013
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Georgetown University

Brief Summary:
Prostate cancer is a common disease in men treated using surgery, radiation therapy and/or hormonal therapy. Clinical prognosis relates to stage and grade of disease. Recent advances in omic analysis may offer additional information to the physician about prognosis and radiation response. We propose to establish a protocol to incorporate omic analysis into the evaluation and treatment of patients with prostate cancer.

Condition or disease Intervention/treatment
Prostate Cancer Radiation: Radiation Therapy

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Pilot Study to Establish a Standardized Protocol for Omic Analysis of Patients With Clinically Localized Prostate Cancer Receiving Radiation Therapy
Study Start Date : January 2009
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Prostate Cancer Patients
Prostate cancer patients who underwent radiation therapy
Radiation: Radiation Therapy
Other Name: Prostate stereotactic body radiation therapy (SBRT) and intensive modulated radiation therapy (IMRT) or the combination of both (boost)

Healthy control
age-matched male who has no known prostate cancer



Primary Outcome Measures :
  1. molecular changes in biofluid [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Specimen:For future Research Optional Destruction if requested identifiable Urine yes no yes no Sputum yes no yes no Blood yes no yes no


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 to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
200 prostate cancer patients vs. 200 healthy men
Criteria

Inclusion Criteria:

  • Males who are older than 18 years old,
  • with clinically localized prostate cancer
  • are receiving radiation therapy

Exclusion Criteria:


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): NCT01968538


Locations
United States, Virginia
Georgetown University Hospital
Arlington, Virginia, United States, 22209
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Sean P Collins, MD, PhD Georgetown University Hospital

Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT01968538     History of Changes
Other Study ID Numbers: 2009-096
First Posted: October 24, 2013    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases