- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01985828
CyberKnife® as Monotherapy or Boost SBRT for Intermediate or High Risk Localized Prostate Cancer
Prospective Evaluation of CyberKnife® as Monotherapy or Boost Stereotactic Body Radiotherapy for Intermediate or High Risk Localized Prostate Cancer
The primary objective of this study is to document the effectiveness of Cyberknife stereotactic body radiotherapy (SBRT) in the treatment of intermediate and high-risk localized prostate cancer defined by biochemical Disease-Free Survival (bDFS), using Phoenix and American Society of Therapeutic Radiation and Oncology (ASTRO) definitions, at 5 years.
During the prostate-specific antigen era, an ever-increasing percentage of men with prostate cancer have presented with clinically localized, potentially curable disease. Although conventional treatment options are potentially curative in selected patients, these treatments also have drawbacks, including the risk of negative long-term quality of life consequences and serious complications.
The CyberKnife® system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal.
Intermediate risk patients will be treated with either CyberKnife® Stereotactic Body Radiation Therapy (SBRT) monotherapy or CyberKnife® SBRT boost followed by Intensity Modulated Radiation Therapy (IMRT). High risk patients will be treated with CyberKnife® SBRT boost followed by IMRT. Treatment will last 4-7 days. Patients will complete the QOL questionnaires before treatment. Questionnaires will also be completed during follow-up visits at 1, 3 , 6, 12, 18, 24, 30 and 36 months then every 12 months until year 5.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arica Hirsch, MD
- Phone Number: 847-723-8030
Study Locations
-
-
Illinois
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Park Ridge, Illinois, United States, 60068
- Recruiting
- Advocate Lutheran General Hospital
-
Principal Investigator:
- Arica Hirsch, MD
-
Contact:
- Arica Hirsch, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- Patient must be ≥ 18 years of age.
Histologically proven prostate adenocarcinoma
- Gleason score 2-10 (reviewed by reference lab)
- Biopsy within one year of date of registration
- Clinical stage T1b-T4, N0-Nx, M0-Mx (AJCC 7th Edition)
- T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI; see section 4.5)
- M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases.
- PSA ≤ 50 ng/ml, CBC, platelets, BUN, creatinine prior to treatment
Patients belonging in one of the following risk groups:
- Intermediate: CS T2b-c and Gleason <6 and PSA ≤ 10, or CS T1b-T2b, and Gleason 7 and PSA ≤ 10 ng/ml, or Gleason <6 and PSA 11-20 ng/ml
- High: CS T3-4, Gleason score >7and PSA<50
Prostate volume: ≤ 100 cc
- Determined using: volume = π/6 x length x height x width
- Measurement from MRI, CT or ultrasound prior to registration.
- ECOG performance status 0-1
- No prior prostatectomy or cryotherapy of the prostate
- No prior radiotherapy to the prostate or lower pelvis
- No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
- No chemotherapy for a malignancy in the last 5 years.
- No history of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intermediate Risk
Short term (4-6 months) androgen deprivation therapy (ADT) per current standard of care + CyberKnife 21 Gy (7 Gy x 3) and Prostate/SV Intensity Modulated radiation therapy (IMRT) 45-50.4 Gy OR Short term (4-6 months)androgen deprivation therapy + CyberKnife 36.35 Gray (7.27 Gray x 5) |
Per current standard of care
|
Experimental: High Risk
Short or Long term (6 months - 3 years) androgen deprivation therapy (ADT) + 45-50.4
Gy and Pelvis Intensity Modulated radiation therapy (IMRT) per current standard of care + 21 Gy (7 Gy x 3) CyberKnife boost
|
Per current standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Biochemical Disease-Free Survival (bDFS), using Phoenix and ASTRO definitions
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity
Time Frame: 5 years
|
5 years
|
|
Measure local failure rates
Time Frame: 5 years
|
Measurement of local recurrence of prostate cancer
|
5 years
|
Measure distant failure rates
Time Frame: 5 years
|
Measurement of distant metastasis rate
|
5 years
|
Measure clinical disease-free survival rates
Time Frame: 5 years
|
5 years
|
|
Measure disease-specific survival rates
Time Frame: 5 years
|
5 years
|
|
Measure Overall Survival
Time Frame: 5 years
|
5 years
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life (QOL) in generic and organ-specific domains
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arica Hirsch, MD, Advocate Lutheran General Hospital
- Study Chair: Majid M Mohiuddin, MD, Advocate Lutheran General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5307
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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