Status:
TERMINATED
Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
Up to 120 years
Phase:
NA
Brief Summary
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This trial is studying the side effects of stereotactic rad...
Detailed Description
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® st...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00619515
Start Date
December 1 2007
End Date
February 1 2013
Last Update
August 22 2019
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
2
University Suburban Health Center
Cleveland, Ohio, United States, 44121
3
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, United States, 44122
4
UH-Westlake
Westlake, Ohio, United States, 44145