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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: January 26, 2017
Last verified: January 2017
January 9, 2013
January 26, 2017
December 2012
December 2018   (Final data collection date for primary outcome measure)
  • fatigue [ Time Frame: 2 years ]
    Use questionnaire to assess patient's symptoms regarding fatigue
  • urinary symptoms [ Time Frame: 24 months ]
    Use questionnaire to assess patient's symptoms regarding urinary symptoms after radiosurgery
  • bowel symptoms [ Time Frame: 24 months ]
    Use questionnaire to assess patient's symptoms regarding bowel symptoms after radiosurgery
  • sexual function [ Time Frame: 24 months ]
    Use questionnaire to assess patient's symptoms regarding sexual symptoms after radiosurgery
Same as current
Complete list of historical versions of study NCT01766492 on ClinicalTrials.gov Archive Site
  • cancer control [ Time Frame: 24 months ]
    clinical evidence of localized and distal cancer controls
  • toxicity [ Time Frame: 24 months ]
    Evaluate all the treatment-related toxicity by both clinical evidence(physical exam and lab) and quality of life questionnaire
Same as current
Not Provided
Not Provided
 
Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Radiosurgery
Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Stereotactic Body Radiation Therapy (SBRT)
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Men (> 18 y/o) with clinically localized prostate cancer,
  • Prostate Cancer
  • Localized Malignant Neoplasm
Radiation: Stereotactic Body Radiation Therapy (SBRT)
Stereotactic body radiation therapy for prostate
Other Name: CyberKnife radiosurgery
male (age > 18 y/o) with prostate cancer
Men received Stereotactic Body Radiation Therapy (SBRT) for clinically localized prostate cancer
Intervention: Radiation: Stereotactic Body Radiation Therapy (SBRT)
Dearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK; RT01 collaborators. Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2007 Jun;8(6):475-87.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2018
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01766492
2012-1175
No
Not Provided
Plan to Share IPD: No
Plan Description: NO individual data will be made available
Georgetown University
Georgetown University
Not Provided
Principal Investigator: Sean P Collins, MD, PhD Georgetown University Hospital
Georgetown University
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP