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Stereotactic Body Radiotherapy for Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by St. John's Mercy Research Institute, St. Louis
Sponsor:
Information provided by (Responsible Party):
St. John's Mercy Research Institute, St. Louis
ClinicalTrials.gov Identifier:
NCT01352598
First received: May 10, 2011
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of organ confined prostate cancer.


Condition Intervention Phase
Prostate Cancer
Radiation: stereotactic body radiotherapy
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer

Resource links provided by NLM:


Further study details as provided by St. John's Mercy Research Institute, St. Louis:

Primary Outcome Measures:
  • Biochemical control rate [ Time Frame: one year ] [ Designated as safety issue: No ]
    Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular intervals.The "Phoenix definition" for biochemical recurrence (nadir + 2 ng/ml) will be used.


Secondary Outcome Measures:
  • late toxicity rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Toxicity will be recorded using the CTCAE grading criteria.


Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: stereotactic body radiotherapy
    Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.
Detailed Description:

This is a single site, non-randomized, prospective, phase IV trial of patients with organ-confined prostate cancer. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues,tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient age >= 18 years
  • Zubrod performance status of 0-3
  • T1-3 N0 M0 adenocarcinoma of the prostate
  • Prostate volume ≤ 100 cc
  • Signed study-specific consent form

Exclusion Criteria

  • Extension of local tumor to involve adjacent organs other than seminal vesicles (T4)
  • Prostate volume > 100 cc
  • Nodal involvement
  • Metastatic disease
  • Prior pelvic radiotherapy except as part of combination therapy for prostate cancer
  • History of scleroderma
  • Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
  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: NCT01352598

Contacts
Contact: Jaymeson Stroud, MD 314-251-6844 jaymeson.stroud@mercy.net

Locations
United States, Missouri
Mercy Hospital St. Louis Recruiting
St. Louis, Missouri, United States, 63141
Sponsors and Collaborators
St. John's Mercy Research Institute, St. Louis
  More Information

No publications provided

Responsible Party: St. John's Mercy Research Institute, St. Louis
ClinicalTrials.gov Identifier: NCT01352598     History of Changes
Other Study ID Numbers: 11-022
Study First Received: May 10, 2011
Last Updated: June 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. John's Mercy Research Institute, St. Louis:
prostate cancer
stereotactic radiotherapy

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

ClinicalTrials.gov processed this record on November 20, 2014