Purpose

In this study, participants will have standard Androgen Deprivation Therapy and undergo standard external beam radiation therapy to the prostate and at-risk lymph nodes by Intensity Modulated Radiation Therapy. The subsequent *boost* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Histologically proven adenocarcinoma of the prostate a. Gleason score (2-10) b. Biopsy within six months of date of registration 2. Clinical stage (American Joint Committee on Cancer 7th Edition) a. T-stage determined by physical exam i. MRI findings (e.g. extracapsular extension) should not influence T-staging, but should be noted for later analysis b. N-stage determined using abdominopelvic CT scan c. M-stage determined by physical exam, CT and/or MRI, and bone scan 3. Patients must belong to one of the following risk groups: a. Very High risk: Stage cT3 and Gleason 8-10 and prostate-specific antigen less than 150 b. High risk: Stage cT1-T2 and Gleason 8-10 and prostate-specific antigen less than 150 c. Moderate high risk: Stage cT3 and Gleason 7 and any prostate-specific antigen. Intermediate to high risk (a) Stage cT3 and Gleason 6 and prostate-specific antigen at least 30 e. Intermediate to high risk (b): Stage cT1-T2 and Gleason 7 and prostate-specific antigen at least 30 4. Patient is planned to undergo standard androgen deprivation therapy and initial Intensity Modulated Radiation Therapy (IMRT) to the prostate and at-risk lymph nodes. 5. Prostate volume greater than 20 cc and less than 100 cc 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 7. Patient has agreed to complete questionnaires 8. Signed Institutional Review Board (IRB) approved informed consent

Exclusion Criteria

  1. No prior prostate surgery or prostate cancer treatment 2. No prior radiotherapy to the pelvis 3. No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery 4. No chemotherapy for a malignancy in the last 5 years. 5. No history of an invasive malignancy (other than basal or squamous skin cancers) in the last 5 years. 6. No history of a horseshoe kidney 7. No diagnosis of inflammatory bowel disease 8. No heart pacemaker, No metallic foreign body (metal sliver) in the eye, No aneurysm clip in the brain 9. Must be able to tolerate the confinement of an MRI procedure

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Boost
CyberKnife Boost 21 Gy in 7 Gy per day, 3 fractions, Every other day
  • Radiation: CyberKnife Boost
    21 Gy in 7 Gy per day, 3 fractions, Every other day
    Other names:
    • stereotactic radiotherapy, cyberknife, radiation

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Annie Jose, BS
617-638-8213
annie.jose@bmc.org

More Details

Status
Recruiting
Sponsor
Boston Medical Center

Study Contact

Ariel Hirsch, MD
617-638-7070
ariel.hirsch@bmc.org

Detailed Description

In this study, participants will have standard androgen deprivation therapy and undergo standard radiation therapy to the prostate and at-risk lymph nodes by intensity-modulated radiation therapy (IMRT). The subsequent *boost* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.