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.
Active, not recruiting
Phase 2
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.
| Name | Type | Description | Interventions |
|---|---|---|---|
| SBRT | Other |
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Male |
| Healthy Volunteers: | No |
| Measure: | To determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher GI and GU toxicity observed during a 24 month follow up |
| Time Frame: | 24 months |
| Safety Issue: | |
| Description: |
| Measure: | To determine the rate of local failure, the rate of distant failure, the overall survival, the quality of life in generic and organ-specific domains |
| Time Frame: | 24 months |
| Safety Issue: | |
| Description: |
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Adam Olson |
August 31, 2020
