Prospective Evaluation of Cyberknife Stereotactic Radiosurgery for Low and Low/Intermediate Risk Prostate Cancer
N/A
N/A
Male
Prostate Cancer
Trial Information
Prospective Evaluation of Cyberknife Stereotactic Radiosurgery for Low and Low/Intermediate Risk Prostate Cancer
OBJECTIVES:
Primary
- To estimate in both low- and low-to-intermediate-risk groups of patients with prostate
cancer, the rate of acute toxicities observed during the 5 years following CyberKnife®
stereotactic radiosurgery (SRS).
Secondary
- To estimate the rate of late grade 3-5 toxicities after SRS in these patients.
- To measure biochemical disease-free survival of patients treated with this therapy.
- To measure rates of local failure, distant failure, disease-free survival,
disease-specific survival, and overall survival of patients treated with this therapy.
- To measure quality of life in generic and organ-specific domains in patients treated
with this therapy.
- To evaluate imaging modalities and their potential role in the detection of prostate
cancer persistence, recurrence, and/or progression in patients treated with this
therapy.
OUTLINE: Patients are stratified according to risk group (low risk vs low/intermediate
risk).
Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients
undergo CyberKnife® stereotactic radiosurgery once daily for 5 days.
Patients complete 4 questionnaires at baseline and periodically during study to assess acute
and late toxicities and quality of life (e.g., overall health status, patient function,
sexual function, and urinary symptoms).
After completion of study therapy, patients are followed for up to 5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Disease confirmed by biopsy within 1 year of study entry
- Gleason score 2-7(3+4)
- Clinical stage T1a or T2b, N0 or NX, M0 or MX
- T- stage and N-stage determined by physical exam and available imaging
studies (i.e., ultrasound, CT scan, and/or MRI)
- M-stage determined by physical exam, CT scan, and/or MRI
- Bone scan is not required unless clinical findings suggest possible
osseous metastases
- PSA ≤ 10 ng/mL within the past 60 days
- At risk for recurrence, as defined by 1 of the following risk groups:
- Low-risk, defined by the following combination:
- Stage T1a-T2a, Gleason 2-6, and PSA ≤ 10 ng/mL
- Low- to-Intermediate-risk, defined by either of the following combinations:
- Stage T2b, Gleason 2-6, and PSA ≤ 10 ng/mL
- Stage T2b, Gleason 3+4=7, and PSA ≤ 10 ng/mL
- Prostate volume must be ≤ 100 cc
- Determined by measurement from CT scan or ultrasound within the past 90 days or
within the past 14 days if hormone therapy is given
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- No implanted hardware or other material that would prohibit appropriate treatment
planning or treatment delivery, in the investigator's opinion
PRIOR CONCURRENT THERAPY:
- No prior definitive therapy for prostate cancer, including prostatectomy,
cryotherapy, or radiotherapy to the prostate or lower pelvis
- No more than 6 months of hormone ablation for gland downsizing
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of acute toxicities as assessed by NCI CTCAE v3.0
Outcome Description:
This study's primary goal is to determine the rate of acute grade 3-5 toxicities following CyberKnife treatment. Per RTOG/ECOG, acute toxicity will be defined as occurring within 90 days of completing treatment.
Outcome Time Frame:
Within 90 days of completing treatment
Safety Issue:
Yes
Principal Investigator
Lee E. Ponsky, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CASE13807
NCT ID:
NCT00619515
Start Date:
December 2007
Completion Date:
February 2013
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage I prostate cancer
- stage II prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
| UH-Westlake | Westlake, Ohio 44145 |
| UHHS Chagrin Highlands Medical Center | Orange Villager, Ohio 44122 |
| University Suburban Health Center | South Euclid, Ohio 44121 |
