Clinical trial NCT01766492: Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Radiosurgery
Official title: Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Stereotactic Body Radiation Therapy (SBRT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Localized Malignant Neoplasm
Keywords: prostate cancer
CyberKnife
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men (\> 18 y/o) with clinically localized prostate cancer,

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.

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 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

Primary outcomes:
measure: fatigue
timeFrame: 2 years
measure: urinary symptoms
timeFrame: 24 months
measure: bowel symptoms
timeFrame: 24 months
measure: sexual function
timeFrame: 24 months
Secondary outcomes:
measure: cancer control
timeFrame: 24 months
measure: toxicity symptoms
timeFrame: 24 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
Study officials:
affiliation: Georgetown University Hospital
name: Sean P Collins, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.