Hypofractionated SBRT For Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014