Status:
COMPLETED
Hypofractionated SBRT For Prostate Cancer
Lead Sponsor:
Adam Olson
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity observed during a 2...
Detailed Description
Radiosurgery should be ideal for treating prostate cancer because: * targeting accuracy for static targets is excellent, with an error of about 1mm, * it can adjust for intra-fractional organ motion,...
Eligibility Criteria
Inclusion
- Histologically proven prostate adenocarcinoma
- Gleason score 2-7
- Biopsy within one year of date of registration
- Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)
- T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI)
- M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases.
- PSA ≤ 20 ng/dL
- Patients belonging in one of the following risk groups:
- Low: CS T1b-T2a and Gleason 2-6 and PSA ≤ 10, or
- Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10, or CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/dL, or Gleason 7 and PSA ≤ 10 ng/dL
- Prostate volume: ≤ 100 cc
- Determined using: volume = π/6 x length x height x width
- Measurement from CT or ultrasound ≤90 days prior to registration.
- ECOG performance status 0-1
- Completion of patient questionnaires:FACT-G questionnaire, AUA questionnaire, EPIC-26 questionnaire, SHIM questionnaire, Utilization of Sexual Medications/Devices questionnaire
- Consent signed.
Exclusion
- Prior prostatectomy or cryotherapy of the prostate
- Prior radiotherapy to the prostate or lower pelvis
- Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
- Chemotherapy for a malignancy in the last 5 years.
- History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.
- Hormone ablation for two months prior to enrollment, or during treat
Key Trial Info
Start Date :
October 7 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2022
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT00977860
Start Date
October 7 2010
End Date
July 8 2022
Last Update
May 2 2024
Active Locations (1)
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1
UPMC Hillman Cancer Center - Shadyside Radiation Oncology
Pittsburgh, Pennsylvania, United States, 15232