Clinical trial NCT01508390: Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2012-01-12
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Document rate of biochemical Disease-Free Survival (bDFS)
timeFrame: 5 years
Secondary outcomes:
measure: Rate of local failure
timeFrame: 5 years
measure: Rate of distant failure
timeFrame: 5 years
measure: disease-free survival
timeFrame: 5 years
measure: Rate of disease-specific survival
timeFrame: 5 years
measure: Rate of overall survival
timeFrame: 5 years
measure: Estimate the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity
timeFrame: 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Ariel Hirsch, MD
role: PRINCIPAL_INVESTIGATOR
References: