Clinical trial NCT00977860: Hypofractionated SBRT For Prostate Cancer
Official title: Prospective Evaluation Of Hypofractionated Stereotactic Body Radiotherapy For Low And Intermediate Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate
Stereotactic
Radiosurgery
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2009-09-16
Enrollment: 163
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: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Acute Grade 3 or Higher GI and GU Toxicities
timeFrame: Up to 90 days
measure: Rate of Late Grade 3 or Higher GI and GU Toxicities
timeFrame: After 90 days post-treatment, up to 5 years per patient
measure: Biochemical Disease-Free Survival Rate (bDFS)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Rate of Local Failure
timeFrame: Up to 5 years
measure: Rate of Distant Failure
timeFrame: Up to 5 years
measure: 5-year Overall Survival (OS)
timeFrame: At 5 years
measure: Quality of Life (QoL) - FACT-G - Prior to Therapy
timeFrame: Prior to start of therapy
measure: Quality of Life (QoL) - FACT-G - At 24 Months
timeFrame: At 24 months (post-start of therapy)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center - Shadyside Radiation Oncology
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Adam Olson, MD
role: PRINCIPAL_INVESTIGATOR
References: