Recruiting

Radiosurgery

Sponsor:

Georgetown University

Code:

NCT01766492

Conditions

Prostate Cancer

Localized Malignant Neoplasm

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Body Radiation Therapy (SBRT)

Study Details

Brief summary:

Quality of life data following SBRT for prostate cancer has been obtained in only a small numbers of patients. A prospective study using validated quality of life questionnaires is needed to determine outcomes after treatment with SBRT. Our study will be the first essential step in developing a better evidence base on the comparative risks and benefits of SBRT treatment with regards to quality of life assessment and outcomes.

Conditions

Prostate Cancer

Localized Malignant Neoplasm

Study ID

NCT01766492

Start date

Dec, 2012

Status verified date

Feb, 2023

Completion date

Apr, 2025

Anticipated

Primary completion date

Apr, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of prostate
  • Signed study-specific consent
  • Prostate Specific Antigen (PSA) within 60 days of registration

Exclusion Criteria:

  • Prior pelvic radiotherapy
  • Prior radical prostate surgery
  • Medical or psychiatric illness that would interfere with treatment or follow up
  • Implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

male (age > 18 y/o) with prostate cancer

Men received Stereotactic Body Radiation Therapy (SBRT) for clinically localized prostate cancer

Interventions

Stereotactic Body Radiation Therapy (SBRT)

Stereotactic body radiation therapy for prostate

Primary outcome measure

  • fatigue [ Time Frame: 2 years ]
  • urinary symptoms [ Time Frame: 24 months ]
  • bowel symptoms [ Time Frame: 24 months ]
  • sexual function [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Malika T Danner

202-444-3068mtd@georgetown.edu

Sean P Collins, MD, PhD

202-444-3292spc9@gunet.georgetown.edu

Locations

Georgetown University Hospital

Recruiting

Washington, District of Columbia, United States, 20007

Contacts

Robyn A Cyr

202-444-3068Robyn.A.Cyr@gunet.georgetown.edu

Sean P Collins, MD, PhD

202-444-3292spc9@gunet.georgetown.edu

Principal Investigator:

Sean P Collins, MD, PhD

More Information

Sponsor

Georgetown University

Last update posted

Feb 23, 2023

Last verified

Feb, 2023

Keywords

  • prostate cancer
  • CyberKnife

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2023-02-23.