CyberKnife® as Monotherapy or Boost SBRT for Intermediate or High Risk Localized Prostate Cancer
Prostate Adenocarcinoma
About this trial
This is an interventional treatment trial for Prostate Adenocarcinoma focused on measuring Prostate neoplasm, Prostate Cancer
Eligibility Criteria
- Patient must be ≥ 18 years of age.
Histologically proven prostate adenocarcinoma
- Gleason score 2-10 (reviewed by reference lab)
- Biopsy within one year of date of registration
- Clinical stage T1b-T4, N0-Nx, M0-Mx (AJCC 7th Edition)
- T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI; see section 4.5)
- M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases.
- PSA ≤ 50 ng/ml, CBC, platelets, BUN, creatinine prior to treatment
Patients belonging in one of the following risk groups:
- Intermediate: CS T2b-c and Gleason <6 and PSA ≤ 10, or CS T1b-T2b, and Gleason 7 and PSA ≤ 10 ng/ml, or Gleason <6 and PSA 11-20 ng/ml
- High: CS T3-4, Gleason score >7and PSA<50
Prostate volume: ≤ 100 cc
- Determined using: volume = π/6 x length x height x width
- Measurement from MRI, CT or ultrasound prior to registration.
- ECOG performance status 0-1
- No prior prostatectomy or cryotherapy of the prostate
- No prior radiotherapy to the prostate or lower pelvis
- No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
- No chemotherapy for a malignancy in the last 5 years.
- No history of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.
Sites / Locations
- Advocate Lutheran General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Intermediate Risk
High Risk
Short term (4-6 months) androgen deprivation therapy (ADT) per current standard of care + CyberKnife 21 Gy (7 Gy x 3) and Prostate/SV Intensity Modulated radiation therapy (IMRT) 45-50.4 Gy OR Short term (4-6 months)androgen deprivation therapy + CyberKnife 36.35 Gray (7.27 Gray x 5)
Short or Long term (6 months - 3 years) androgen deprivation therapy (ADT) + 45-50.4 Gy and Pelvis Intensity Modulated radiation therapy (IMRT) per current standard of care + 21 Gy (7 Gy x 3) CyberKnife boost