Hypofractionated SBRT For Prostate Cancer

Adam Olson

Status

Completed

Conditions

Prostate Cancer

Treatments

Radiation: Stereotactic Body Radiation Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00977860

HCC 09-031

Details and patient eligibility

About

The purpose of this study is to determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity observed during a 24 month follow up and to estimate the rate of biochemical Disease-Free Survival, Phoenix and American Society for Therapeutic Radiology and Oncology definitions, at 2 years following hypofractionated stereotactic body radiation therapy for low and intermediate risk prostate cancer.

Full description

Radiosurgery should be ideal for treating prostate cancer because:

targeting accuracy for static targets is excellent, with an error of about 1mm,
it can adjust for intra-fractional organ motion, reducing the volume of the target PTV and therefore the dose to surrounding organs,
by using over one-hundred non-conplanar beams, the dose gradient between the prostate and surrounding tissues may be superior to that achieved with conventional linear accelerators,
the radiobiology of prostate cancer may favor large dose per fractions.

Enrollment

163 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically proven prostate adenocarcinoma
Gleason score 2-7
Biopsy within one year of date of registration
Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)
T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI)
M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases.
PSA ≤ 20 ng/dL
Patients belonging in one of the following risk groups:
Low: CS T1b-T2a and Gleason 2-6 and PSA ≤ 10, or
Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10, or CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/dL, or Gleason 7 and PSA ≤ 10 ng/dL
Prostate volume: ≤ 100 cc
Determined using: volume = π/6 x length x height x width
Measurement from CT or ultrasound ≤90 days prior to registration.
ECOG performance status 0-1
Completion of patient questionnaires:FACT-G questionnaire, AUA questionnaire, EPIC-26 questionnaire, SHIM questionnaire, Utilization of Sexual Medications/Devices questionnaire
Consent signed.

Exclusion criteria

Prior prostatectomy or cryotherapy of the prostate
Prior radiotherapy to the prostate or lower pelvis
Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
Chemotherapy for a malignancy in the last 5 years.
History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.
Hormone ablation for two months prior to enrollment, or during treat