Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate

Phase II Study of Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate for Treatment of Localized, Non-Metastatic, High Risk Prostate Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: CyberKnife Boost

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Histologically proven adenocarcinoma of the prostate

   1. Gleason score (2-10)
   2. Biopsy within six months of date of registration
   3. Patient age >18 years

2. Clinical stage (American Joint Committee on Cancer 7th Edition)

   a. T-stage determined by physical exam (Digital Rectal Exam Required)

   i. MRI findings (e.g. extracapsular extension) can be used to determine T-staging

   b. N-stage determined using abdominopelvic CT scan and/or MRI

   c. M-stage determined by physical exam, CT and/or MRI, and bone scan (must be M0, excepting Lymph nodes)

   Please note: a SPECT bone scan including a CT of the abdomen and pelvis or an F18 Fluciclovine PET/CT fulfills protocol criteria for both the abdominopelvic CT and bone scan.

3. Patients must belong to one of the following risk groups:

   • PSA > 20 and < 150 and/or
   • Gleason 8-10 and/or
   • > clinical T3a and/or
   • Clinical N1

   OR

   • PSA 10 - 20 AND
   • Gleason 7 AND
   • Clinical T2b - T2c
4. Patient is receiving, or planning to receive standard androgen deprivation therapy and initial IMRT to the prostate and positive or 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 IRB approved informed consent
9. Patient eligible to have an MRI
10. Must be able to tolerate the confinement of an MRI procedure

Exclusion Criteria:

1. No prior prostate surgery (including TURP) or prostate cancer treatment with the exception of androgen deprivation therapy
2. No prior radiotherapy to the pelvis
3. No implanted hardware (including metal) or other material that would prohibit appropriate treatment planning or treatment delivery
4. No metastatic disease, with the exception of lymph node positive disease
5. No chemotherapy for a malignancy in the last 5 years.
6. No history of an invasive malignancy (other than basal or squamous skin cancers) in the last 5 years.
7. No heart pacemaker, No metallic foreign body (metal sliver) in the eye, No aneurysm clip in the brain
8. No history of a pelvic or horseshoe kidney
9. No diagnosis of inflammatory bowel disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Document rate of biochemical Disease-Free Survival (bDFS)	To document the rate of biochemical Disease-Free Survival (bDFS), American Society for Radiation Oncology definitions	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of local failure	Rate of local failure	5 years
Rate of distant failure	Rate of distant failure	5 years
disease-free survival	disease-free survival	5 years
Rate of disease-specific survival	Rate of disease-specific survival	5 years
Rate of overall survival	Rate of overall survival	5 years
Estimate the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity	rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity following combination androgen deprivation therapy, External Beam Radiation Therapy and CyberKnife radiosurgery as a boost	5 years

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Ariel Hirsch, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 9, 2011
• First Submitted That Met QC Criteria: January 11, 2012
• First Posted (Estimated): January 12, 2012

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: prostate
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: H-29665

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes