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
About this trial
This is an interventional treatment trial for Prostatic Neoplasms
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
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
NCT ID
NCT02344667
First Posted
January 13, 2015
Last Updated
January 18, 2015
Sponsor
Juravinski Cancer Center
Collaborators
Juravinski Cancer Centre Foundation
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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