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

Primary Purpose

Prostatic Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Stereotactic Body Radiotherapy
Sponsored by
Juravinski Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Histologically confirmed diagnosis of adenocarcinoma of the prostate
  • Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores ≤ 7
  • Clinical stage T1-2b (AJCC 7th edition)
  • PSA ≤ 10 ng/mL. PSA should not be obtained within 10 days after prostate biopsy.
  • ECOG Performance Status 0-1

Exclusion Criteria:

  • Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years.
  • Evidence of distant metastases
  • Regional lymph node involvement
  • Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer. Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
  • Previous hormonal therapy, such as LHRH agonists or LHRH antagonists, anti-androgens, estrogens, or surgical castration
  • Use of finasteride or dutasteride within 30 days prior to registration. PSA should not be obtained prior to 30 days after stopping finasteride or dutasteride.
  • Previous or concurrent cytotoxic chemotherapy for prostate cancer
  • Age < 18
  • Patient unable to provide study-specific informed consent
  • Inability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Cyberknife

    Volume Modulated Arc Therapy

    Arm Description

    Cyberknife based SBRT 36.25 Gy in 5 fractions

    Volume Modulated Arc Therapy based SBRT 36.25 Gy in 5 fractions

    Outcomes

    Primary Outcome Measures

    Patient acceptability of a randomized trial comparing Cyberknife and Volume Modulated Arc Therapy (VMAT) based SBRT techniques for the treatment of localized prostate cancer as measured by number of patients willing to participate in randomized trial.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 13, 2015
    Last Updated
    January 18, 2015
    Sponsor
    Juravinski Cancer Center
    Collaborators
    Juravinski Cancer Centre Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02344667
    Brief Title
    Feasibility Study of Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer: Cyberknife vs. VMAT
    Official Title
    Randomized Feasibility Study of Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer: Cyberknife vs. Volume Modulated Arc Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    July 2016 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Juravinski Cancer Center
    Collaborators
    Juravinski Cancer Centre Foundation

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostatic Neoplasms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cyberknife
    Arm Type
    Experimental
    Arm Description
    Cyberknife based SBRT 36.25 Gy in 5 fractions
    Arm Title
    Volume Modulated Arc Therapy
    Arm Type
    Experimental
    Arm Description
    Volume Modulated Arc Therapy based SBRT 36.25 Gy in 5 fractions
    Intervention Type
    Radiation
    Intervention Name(s)
    Stereotactic Body Radiotherapy
    Primary Outcome Measure Information:
    Title
    Patient acceptability of a randomized trial comparing Cyberknife and Volume Modulated Arc Therapy (VMAT) based SBRT techniques for the treatment of localized prostate cancer as measured by number of patients willing to participate in randomized trial.
    Time Frame
    15 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Histologically confirmed diagnosis of adenocarcinoma of the prostate Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores ≤ 7 Clinical stage T1-2b (AJCC 7th edition) PSA ≤ 10 ng/mL. PSA should not be obtained within 10 days after prostate biopsy. ECOG Performance Status 0-1 Exclusion Criteria: Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. Evidence of distant metastases Regional lymph node involvement Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer. Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy Previous hormonal therapy, such as LHRH agonists or LHRH antagonists, anti-androgens, estrogens, or surgical castration Use of finasteride or dutasteride within 30 days prior to registration. PSA should not be obtained prior to 30 days after stopping finasteride or dutasteride. Previous or concurrent cytotoxic chemotherapy for prostate cancer Age < 18 Patient unable to provide study-specific informed consent Inability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Joanna Laba, MD
    Phone
    905-387-9495
    Ext
    64702
    Email
    labaj@hhsc.ca

    12. IPD Sharing Statement

    Learn more about this trial

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

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