Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate

NCT01508390 | Active Not Recruiting DMC FDA Device

• 1 other identifier: H-29665
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

prostate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Rate of local failure

  5 years

• Rate of distant failure

  5 years

• disease-free survival

  5 years

• Rate of disease-specific survival

  5 years

• Rate of overall survival

  5 years

Study Arms (1)

Boost

EXPERIMENTAL

CyberKnife Boost 21 Gy in 7 Gy per day, 3 fractions, Every other day

Radiation: CyberKnife Boost

Interventions

CyberKnife Boost RADIATION

21 Gy in 7 Gy per day, 3 fractions, Every other day

Also known as: stereotactic radiotherapy, cyberknife, radiation

Boost

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven adenocarcinoma of the prostate
• Gleason score (2-10)
• Biopsy within six months of date of registration
• Patient age \>18 years
• 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.
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery; Radiation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Physical Phenomena

Study Officials

• Ariel Hirsch, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2011
• First Posted: January 12, 2012
• Study Start: June 1, 2011
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)