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Status unknownNCT01766492PR-PROSUpdated Feb 23, 2023

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

An observational study in Prostate Cancer and Localized Malignant Neoplasm, sponsored by Georgetown University. Status unknown at 1 site in United States. Open to male participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-02-23.

Sponsored by Georgetown University · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 99 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Prostate Cancer
  • Localized Malignant Neoplasm

Keywords

  • prostate cancer
  • CyberKnife
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Georgetown University is the lead sponsor of 286 studies on the registry; 42 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Men (> 18 y/o) with clinically localized prostate cancer,

Inclusion criteria

  • Histologically confirmed adenocarcinoma of prostate
  • Signed study-specific consent
  • Prostate Specific Antigen (PSA) within 60 days of registration

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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)

Interventions

  • RadiationStereotactic Body Radiation Therapy (SBRT)

    Stereotactic body radiation therapy for prostate

    Also known as: CyberKnife radiosurgery

06

What researchers measure

Primary outcomes

  1. fatigue

    Use questionnaire to assess patient's symptoms regarding fatigue

    Time frame: 2 years

  2. urinary symptoms

    Use questionnaire to assess patient's symptoms regarding urinary symptoms after radiosurgery

    Time frame: 24 months

  3. bowel symptoms

    Use questionnaire to assess patient's symptoms regarding bowel symptoms after radiosurgery

    Time frame: 24 months

  4. sexual function

    Use questionnaire to assess patient's symptoms regarding sexual symptoms after radiosurgery

    Time frame: 24 months

Secondary outcomes

  1. cancer control

    clinical evidence of localized and distal cancer controls

    Time frame: 24 months

  2. toxicity symptoms

    Evaluate all the treatment-related toxicity by both clinical evidence(physical exam and lab) and quality of life questionnaire

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • Georgetown University Hospital
    Washington, District of Columbia 20007, United States
    Recruiting
08

References and documents

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. PubMed 17482880 ↗
  • 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. PubMed 29487023 ↗

Individual participant data

Plan to share: No — NO individual data will be made available

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01766492
Lead sponsor
Georgetown University
Responsible party
Sponsor
First posted
Jan 11, 2013
Start date
Dec 2012
Primary completion
Apr 2025 (estimated)
Completion
Apr 2025 (estimated)
Last update
Feb 23, 2023

Study contacts

Malika T Danner
Contact
mtd@georgetown.edu
202-444-3068
Sean P Collins, MD, PhD
Contact
spc9@gunet.georgetown.edu
202-444-3292
Sean P Collins, MD, PhD
principal investigator · Georgetown University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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