Description:
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.
Title
- Brief Title: CyberKnife® as Monotherapy or Boost SBRT for Intermediate or High Risk Localized Prostate Cancer
- Official Title: Prospective Evaluation of CyberKnife® as Monotherapy or Boost Stereotactic Body Radiotherapy for Intermediate or High Risk Localized Prostate Cancer
Clinical Trial IDs
- ORG STUDY ID:
5307
- NCT ID:
NCT01985828
Conditions
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Intermediate Risk | Experimental | 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) | |
High Risk | Experimental | 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 | |
Eligibility Criteria
- 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Biochemical Disease-Free Survival (bDFS), using Phoenix and ASTRO definitions |
Time Frame: | 5 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Measure the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity |
Time Frame: | 5 years |
Safety Issue: | |
Description: | |
Measure: | Measure local failure rates |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Measurement of local recurrence of prostate cancer |
Measure: | Measure distant failure rates |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Measurement of distant metastasis rate |
Measure: | Measure clinical disease-free survival rates |
Time Frame: | 5 years |
Safety Issue: | |
Description: | |
Measure: | Measure disease-specific survival rates |
Time Frame: | 5 years |
Safety Issue: | |
Description: | |
Measure: | Measure Overall Survival |
Time Frame: | 5 years |
Safety Issue: | |
Description: | |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Advocate Health Care |
Trial Keywords
- Prostate neoplasm
- Prostate Cancer
Last Updated
July 20, 2021