NCT01508390Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 9 Dec 2011
- Start date
- Jun 2011
- Primary completion date
- Dec 2027
- Lead sponsor
- Boston Medical Center
- Diseases
- Prostate cancer
- NCT number
- NCT01508390
What you commit to
- Study type: Interventional
- Participants enrolled: 35
- From Jun 2011 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No prior prostate surgery (including TURP) or prostate cancer treatment with the exception of androgen deprivation therapy
- No prior radiotherapy to the pelvis
Other illness
- 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
Other
- No implanted hardware (including metal) or other material that would prohibit appropriate treatment planning or treatment delivery
Who the study is looking for
- 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)
- T-stage determined by physical exam (Digital Rectal Exam Required)
- MRI findings (e.g. extracapsular extension) can be used to determine T-staging
- N-stage determined using abdominopelvic CT scan and/or MRI
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boston Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.