Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT01508390

Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

OR

  • PSA 10 - 20 AND
  • Gleason 7 AND
  • Clinical T2b - T2c
  • Patient is receiving, or planning to receive standard androgen deprivation therapy and initial IMRT to the prostate and positive or at-risk lymph nodes.
  • Prostate volume greater than 20 cc and less than 100 cc
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Patient has agreed to complete questionnaires
  • Signed IRB approved informed consent
  • Patient eligible to have an MRI
  • Must be able to tolerate the confinement of an MRI procedure

Exclusion criteria

  • 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

Treatment and study plan

CyberKnife Boost

Radiation

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

Other names: stereotactic radiotherapy, cyberknife, radiation

Primary outcomes

  1. Document rate of biochemical Disease-Free Survival (bDFS)

    Time frame: 5 years

    To document the rate of biochemical Disease-Free Survival (bDFS), American Society for Radiation Oncology definitions

Secondary outcomes

  1. Rate of local failure

    Time frame: 5 years

    Rate of local failure

  2. Rate of distant failure

    Time frame: 5 years

    Rate of distant failure

  3. disease-free survival

    Time frame: 5 years

    disease-free survival

  4. Rate of disease-specific survival

    Time frame: 5 years

    Rate of disease-specific survival

  5. Rate of overall survival

    Time frame: 5 years

    Rate of overall survival

  6. Estimate the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity

    Time frame: 5 years

    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

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2027
Study completion
2027
First posted
Jan 12, 2012
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.