NCT01766492

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2013

Completed
12.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

12.3 years

First QC Date

January 9, 2013

Last Update Submit

February 22, 2023

Conditions

Prostate CancerLocalized Malignant Neoplasm

Keywords

prostate cancerCyberKnife

Outcome Measures

Primary Outcomes (4)

  • fatigue

    Use questionnaire to assess patient's symptoms regarding fatigue

    2 years

  • urinary symptoms

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

    24 months

  • bowel symptoms

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

    24 months

  • sexual function

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

    24 months

Secondary Outcomes (2)

  • cancer control

    24 months

  • toxicity symptoms

    24 months

Study Arms (1)

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

Stereotactic Body Radiation Therapy (SBRT)RADIATION

Stereotactic body radiation therapy for prostate

Also known as: CyberKnife radiosurgery
male (age > 18 y/o) with prostate cancer

Eligibility Criteria

Age18 Years - 99 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 17482880BACKGROUND

  • 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.

    PMID: 29487023DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Sean P Collins, MD, PhD

    Georgetown University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Malika T Danner

CONTACT

202-444-3068mtd@georgetown.edu

Sean P Collins, MD, PhD

CONTACT

202-444-3292spc9@gunet.georgetown.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2013

First Posted

January 11, 2013

Study Start

December 1, 2012

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

NO individual data will be made available

Locations

US(1)