Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Radiosurgery

Prostate Cancer Clinical Trial

— PR-PROS  

Official title:

Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Stereotactic Body Radiation Therapy (SBRT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01766492
• Other study ID #: 2012-1175
• Status: Recruiting
• Start date: December 2012
• Est. completion date: April 2025

Study information

• Verified date: February 2023
• Source: Georgetown University
• Contact: Malika T Danner
• Phone: 202-444-3068
• Email: mtd[@]georgetown.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Localized Malignant Neoplasm
• Neoplasms
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Stereotactic Body Radiation Therapy (SBRT)
Stereotactic body radiation therapy for prostate

Locations

Country	Name	City	State
United States	Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fatigue	Use questionnaire to assess patient's symptoms regarding fatigue	2 years
Primary	urinary symptoms	Use questionnaire to assess patient's symptoms regarding urinary symptoms after radiosurgery	24 months
Primary	bowel symptoms	Use questionnaire to assess patient's symptoms regarding bowel symptoms after radiosurgery	24 months
Primary	sexual function	Use questionnaire to assess patient's symptoms regarding sexual symptoms after radiosurgery	24 months
Secondary	cancer control	clinical evidence of localized and distal cancer controls	24 months
Secondary	toxicity symptoms	Evaluate all the treatment-related toxicity by both clinical evidence(physical exam and lab) and quality of life questionnaire	24 months