NCT01968538

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 24, 2013

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

15.9 years

First QC Date

September 19, 2013

Last Update Submit

February 27, 2023

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • molecular changes in biofluid

    5 years

Study Arms (2)

Prostate Cancer Patients

Prostate cancer patients who underwent radiation therapy

Radiation: Radiation Therapy

Healthy control

age-matched male who has no known prostate cancer

Interventions

Radiation TherapyRADIATION
Also known as: Prostate stereotactic body radiation therapy (SBRT) and intensive modulated radiation therapy (IMRT) or the combination of both (boost)
Prostate Cancer Patients

Eligibility Criteria

Age18 Years - 100 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

200 prostate cancer patients vs. 200 healthy men

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Hospital

Arlington, Virginia, 22209, United States

Location

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

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

RadiotherapyRadiosurgeryRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative TechniquesRadiotherapy, ConformalRadiotherapy, Computer-Assisted

Study Officials

  • Sean P Collins, MD, PhD

    Georgetown University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2013

First Posted

October 24, 2013

Study Start

January 1, 2009

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

February 28, 2023

Record last verified: 2023-02

Locations

US(1)