Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Radiosurgery (PR-PROS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT01766492
First received: January 9, 2013
Last updated: April 11, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention
Prostate Cancer
Localized Malignant Neoplasm
Radiation: Stereotactic Body Radiation Therapy (SBRT)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Stereotactic Body Radiation Therapy (SBRT)

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • fatigue [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Use questionnaire to assess patient's symptoms regarding fatigue

  • urinary symptoms [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Use questionnaire to assess patient's symptoms regarding urinary symptoms after radiosurgery

  • bowel symptoms [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Use questionnaire to assess patient's symptoms regarding bowel symptoms after radiosurgery

  • sexual function [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Use questionnaire to assess patient's symptoms regarding sexual symptoms after radiosurgery


Secondary Outcome Measures:
  • cancer control [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    clinical evidence of localized and distal cancer controls

  • toxicity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Evaluate all the treatment-related toxicity by both clinical evidence(physical exam and lab) and quality of life questionnaire


Estimated Enrollment: 200
Study Start Date: December 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
male (age > 18 y/o) with prostate cancer
Men received Stereotactic Body Radiation Therapy (SBRT) for clinically localized prostate cancer
Radiation: Stereotactic Body Radiation Therapy (SBRT)
Stereotactic body radiation therapy for prostate
Other Name: CyberKnife radiosurgery

Detailed Description:

Study Design (for example, hypothesis, research question, standard and experimental procedures, special or unusual equipment or procedures):

The main goal of this study is to evaluate quality of life outcomes and changes in patient reported symptoms (e.g. urinary, bowel and sexual function) in patients receiving SBRT treatment for clinically localized prostate cancer. Validated quality of life questionnaires will be administered in a deidentified, prospective fashion. Eligible subjects will be patients undergoing SBRT treatment for prostate cancer.

Hypothesis: Patients undergoing SBRT will have similar cancer control and symptoms as men who are treated with other radiation therapy modalities.

Primary objective: To evaluate quality of life outcomes (e.g. fatigue, urinary, bowel and sexual function) for patients with clinically localized prostate cancer treated with SBRT.

Secondary objectives: Prospective data on cancer control and toxicity following SBRT for clinically localized prostate cancer.

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men (> 18 y/o) with clinically localized prostate cancer,
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766492

Locations
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Sean P Collins, MD, PhD Georgetown University Hospital
  More Information

Publications:
Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT01766492     History of Changes
Other Study ID Numbers: 2012-1175 
Study First Received: January 9, 2013
Last Updated: April 11, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No
Plan Description: NO individual data will be made available

Keywords provided by Georgetown University:
prostate cancer
CyberKnife

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

ClinicalTrials.gov processed this record on July 24, 2016