Hypofractionated SBRT For Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/7/2018 |
| Start Date: | October 2010 |
| End Date: | December 2023 |
| Contact: | Dwight E Heron, MD |
| Email: | herond2@upmc.edu |
| Phone: | 412-623-6720 |
Prospective Evaluation Of Hypofractionated Stereotactic Body Radiotherapy For Low And Intermediate Risk Prostate Cancer
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 24 month follow up and to estimate the rate of biochemical Disease-Free
Survival, Phoenix and American Society for Therapeutic Radiology and Oncology definitions, at
2 years following hypofractionated stereotactic body radiation therapy for low and
intermediate risk prostate cancer.
the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity
observed during a 24 month follow up and to estimate the rate of biochemical Disease-Free
Survival, Phoenix and American Society for Therapeutic Radiology and Oncology definitions, at
2 years following hypofractionated stereotactic body radiation therapy for low and
intermediate risk prostate cancer.
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, reducing the volume of the target PTV
and therefore the dose to surrounding organs,
- by using over one-hundred non-conplanar beams, the dose gradient between the prostate
and surrounding tissues may be superior to that achieved with conventional linear
accelerators,
- the radiobiology of prostate cancer may favor large dose per fractions.
- targeting accuracy for static targets is excellent, with an error of about 1mm,
- it can adjust for intra-fractional organ motion, reducing the volume of the target PTV
and therefore the dose to surrounding organs,
- by using over one-hundred non-conplanar beams, the dose gradient between the prostate
and surrounding tissues may be superior to that achieved with conventional linear
accelerators,
- the radiobiology of prostate cancer may favor large dose per fractions.
Inclusion Criteria:
- 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 Criteria:
- 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
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