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Feasibility Study of Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer: Cyberknife vs. VMAT

NCT02344667 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-01-26

No results posted yet for this study

Summary

Recent studies support the use of Stereotactic Body Radiation Therapy (SBRT) for the treatment of localized prostate cancer (PrCa). SBRT is a way to deliver radiation very precisely allowing higher doses to be delivered with fewer treatments, potentially improving patient outcomes. Cyberknife and Volume Modulated Arc Therapy (VMAT) are accepted SBRT techniques. However, the effects of the specific SBRT treatment technique on patient outcomes have not been evaluated in randomized trials.

Although such a trial would be of great interest, patients' willingness to participate is unclear. Multiple patient and clinician factors contribute to the decision to enter a randomized trial. This feasibility study will evaluate patients' willingness to participate in a trial comparing Cyberknife and VMAT SBRT for the treatment of early stage PrCa. Patients accepting enrolment will be randomized to one of the two types of SBRT delivery. Up to 66 patients will be approached, and up to 40 randomized. A questionnaire will help to identify the factors influencing the patient's decision to participate or not. This study will gather information on feasibility, PSA control, patient outcomes and side effects, and will inform the design of a future randomized phase II/III study.

Conditions

  • Prostatic Neoplasms

Interventions

RADIATION

Stereotactic Body Radiotherapy

Sponsors & Collaborators

  • Juravinski Cancer Centre Foundation

    collaborator OTHER

  • Juravinski Cancer Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02344667 on ClinicalTrials.gov