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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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


Inclusion Criteria:



1. Histologically proven adenocarcinoma of the prostate a. Gleason score (2-10) b.
Biopsy within six months of date of registration

2. Clinical stage (American Joint Committee on Cancer [AJCC] 7th Edition) a. T-stage
determined by physical exam i. MRI findings (e.g. extracapsular extension) should not
influence T-staging, but should be noted for later analysis b. N-stage determined
using abdominopelvic CT scan c. M-stage determined by physical exam, CT and/or MRI,
and bone scan

3. Patients must belong to one of the following risk groups: a. Very High risk: cT3 and
Gleason 8-10 and PSA less than 150 b. High risk: cT1-T2 and Gleason 8-10 and PSA less
than 150 c. Moderate high risk: cT3 and Gleason 7 and any PSA d. Intermediate to high
risk (a) cT3 and Gleason 6 and PSA at least 30 e. Intermediate to high risk (b):
cT1-T2 and Gleason 7 and PSA at least 30

4. Patient is planned to undergo standard androgen deprivation therapy and initial
Intensity Modulated Radiation Therapy (IMRT) to the prostate and 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 Institutional Review Board (IRB) approved informed consent

Exclusion Criteria:

1. No prior prostate surgery or prostate cancer treatment

2. No prior radiotherapy to the pelvis

3. No implanted hardware or other material that would prohibit appropriate treatment
planning or treatment delivery

4. No chemotherapy for a malignancy in the last 5 years.

5. No history of an invasive malignancy (other than basal or squamous skin cancers) in
the last 5 years.

6. No history of a horseshoe kidney

7. No diagnosis of inflammatory bowel disease

8. No heart pacemaker, No metallic foreign body (metal sliver) in the eye, No aneurysm
clip in the brain

9. Must be able to tolerate the confinement of an MRI procedure

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity following combination ADT, EBRT and CyberKnife radiosurgery as a boost

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Ariel Hirsch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston Medical Center

Authority:

United States: Institutional Review Board

Study ID:

H-29665

NCT ID:

NCT01508390

Start Date:

June 2011

Completion Date:

December 2015

Related Keywords:

  • Prostate Cancer
  • prostate
  • Prostatic Neoplasms

Name

Location

Boston Medical CenterBoston, Massachusetts  02118