Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Radiosurgery (PR-PROS)
February 22, 2023 updated by: Georgetown University
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Malika T Danner
- Phone Number: 202-444-3068
- Email: mtd@georgetown.edu
Study Contact Backup
- Name: Sean P Collins, MD, PhD
- Phone Number: 202-444-3292
- Email: spc9@gunet.georgetown.edu
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- Recruiting
- Georgetown University Hospital
-
Principal Investigator:
- Sean P Collins, MD, PhD
-
Contact:
- Sean P Collins, MD, PhD
- Phone Number: 202-444-3292
- Email: spc9@gunet.georgetown.edu
-
Contact:
- Robyn A Cyr
- Phone Number: 202-444-3068
- Email: Robyn.A.Cyr@gunet.georgetown.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Men (> 18 y/o) with clinically localized prostate cancer,
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
male (age > 18 y/o) with prostate cancer
Men received Stereotactic Body Radiation Therapy (SBRT) for clinically localized prostate cancer
|
Stereotactic body radiation therapy for prostate
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
fatigue
Time Frame: 2 years
|
Use questionnaire to assess patient's symptoms regarding fatigue
|
2 years
|
|
urinary symptoms
Time Frame: 24 months
|
Use questionnaire to assess patient's symptoms regarding urinary symptoms after radiosurgery
|
24 months
|
|
bowel symptoms
Time Frame: 24 months
|
Use questionnaire to assess patient's symptoms regarding bowel symptoms after radiosurgery
|
24 months
|
|
sexual function
Time Frame: 24 months
|
Use questionnaire to assess patient's symptoms regarding sexual symptoms after radiosurgery
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cancer control
Time Frame: 24 months
|
clinical evidence of localized and distal cancer controls
|
24 months
|
|
toxicity symptoms
Time Frame: 24 months
|
Evaluate all the treatment-related toxicity by both clinical evidence(physical exam and lab) and quality of life questionnaire
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sean P Collins, MD, PhD, Georgetown University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1016/S1470-2045(07)70143-2.
- Dess RT, Devasia TP, Aghdam N, Jackson WC, Soni PD, Smith CP, Mitchell AL, Suy S, Hamstra DA, Jolly S, Nguyen PL, Feng FY, Schipper MJ, Skolarus TA, Miller DC, Wittmann DA, Collins SP, Spratt DE. Patient-Reported Sexual Aid Utilization and Efficacy After Radiation Therapy for Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2018 Jun 1;101(2):376-386. doi: 10.1016/j.ijrobp.2018.01.055. Epub 2018 Jan 31.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Anticipated)
April 1, 2025
Study Completion (Anticipated)
April 1, 2025
Study Registration Dates
First Submitted
January 9, 2013
First Submitted That Met QC Criteria
January 10, 2013
First Posted (Estimate)
January 11, 2013
Study Record Updates
Last Update Posted (Estimate)
February 23, 2023
Last Update Submitted That Met QC Criteria
February 22, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-1175
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
NO individual data will be made available
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.