Hypofractionated SBRT For Prostate Cancer

This study is currently recruiting participants.
Verified January 2014 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Dwight Heron, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00977860
First received: September 15, 2009
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Radiation: Stereotactic Body Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Evaluation Of Hypofractionated Stereotactic Body Radiotherapy For Low And Intermediate Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • To determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher GI and GU toxicity observed during a 24 month follow up [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • To estimate the rate of biochemical Disease-Free Survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the rate of local failure, the rate of distant failure, the overall survival, the quality of life in generic and organ-specific domains [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 111
Study Start Date: October 2010
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SBRT Radiation: Stereotactic Body Radiation Therapy
36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period
Other Names:
  • CyberKnife
  • Trilogy
  • True Beam
  • Radiosurgery

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977860

Contacts
Contact: Dwight E Heron, MD 412-623-6720 herond2@upmc.edu
Contact: Karen D Holeva 412-623-1275 holevakd@upmc.edu

Locations
United States, Pennsylvania
UPMC Shadyside Radiation Oncology Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Dwight E Heron, MD    412-623-6720    herond2@upmc.edu   
Contact: Rodney Wegner, MD    4126236720    wegnerr@upmc.edu   
Sub-Investigator: Steven A Burton, MD         
Sub-Investigator: Melvin Deutsch, MD         
Sub-Investigator: Yoshio Arai, MD         
Principal Investigator: Rodney E Wegner, MD         
Sub-Investigator: Annette E Quinn, MSN         
Sub-Investigator: Ryan P Smith, MD         
Sub-Investigator: Ronald M Benoit, MD         
Sub-Investigator: John Flickinger, MD         
Sub-Investigator: Gregory Kubicek, MD         
Principal Investigator: Dwight E Heron, MD         
Sub-Investigator: Benjamin Davies, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Dwight E Heron, MD University of Pittsburgh
Principal Investigator: Rodney E Wegner, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Dwight Heron, Vice Chairman of Clinical Affairs, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00977860     History of Changes
Other Study ID Numbers: 09-031
Study First Received: September 15, 2009
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Prostate
Stereotactic
Radiosurgery

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014