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Stereotactic Body Radiotherapy for Prostate Cancer

This study is currently recruiting participants.
Verified March 2017 by Jaymeson Stroud, MD, Mercy Research
Sponsor:
ClinicalTrials.gov Identifier:
NCT01352598
First Posted: May 12, 2011
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jaymeson Stroud, MD, Mercy Research
  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: Intervention Model: Single Group Assignment
Masking: None (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 Jaymeson Stroud, MD, Mercy Research:

Primary Outcome Measures:
  • Biochemical control rate [ Time Frame: one year ]
    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 ]
    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)
Arms Assigned Interventions
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.
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Mercy Research
  More Information

Responsible Party: Jaymeson Stroud, MD, Radiation Oncologist, Mercy Research
ClinicalTrials.gov Identifier: NCT01352598     History of Changes
Other Study ID Numbers: 11-022
First Submitted: May 10, 2011
First Posted: May 12, 2011
Last Update Posted: March 23, 2017
Last Verified: March 2017

Keywords provided by Jaymeson Stroud, MD, Mercy Research:
prostate cancer
stereotactic radiotherapy

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