Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer

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. Read our disclaimer for details. Identifier: NCT00547339
Recruitment Status : Unknown
Verified June 2010 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : October 22, 2007
Last Update Posted : February 21, 2011
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: stereotactic body radiation therapy Phase 1 Phase 2

Detailed Description:



  • To escalate the dose of stereotactic body radiotherapy (SBRT) to a tumoricidal dose without exceeding the maximum tolerated dose in patients with organ-confined prostate cancer. (Phase I)
  • To determine the late, severe grade 3-5 genitourinary and gastrointestinal toxicity occurring between 270-540 days (i.e., 9-18 months) from the start of the protocol treatment as assessed by CTCAE v3.0. (Phase II)


  • To determine the dose-limiting toxicity of SBRT in these patients. (Phase I)
  • To determine the 2-year biochemical (PSA) control (freedom from PSA failure), disease-free and overall survival, local control, freedom from distant metastases, and the incidence of high-grade adverse events of any type in patients treated with this therapy in order to determine if the therapy is promising enough for further clinical investigation. (Phase II)

OUTLINE: This is a multicenter, phase I dose-escalation study followed by a phase II open-label study.

  • Phase I: Patients undergo 5 treatments of stereotactic body radiotherapy (SBRT).
  • Phase II: Patients undergo SBRT at the maximum tolerated dose as in phase I. After completion of study treatment, patients are followed at 1.5, 3, 6, 9, and 12 months, every 6 months for 5 years, and then once a year for years 5-10.

PROJECTED ACCRUAL: A total of 97 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 97 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I and II Study of Stereotactic Body Radiation Therapy (SBRT) for Low and Intermediate Risk Prostate Cancer (SBRT Prostate)
Study Start Date : July 2006
Estimated Primary Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) or a dose of 50 Gy total (whichever comes first)
  2. Late severe genitourinary (GU) and gastrointestinal (GI) toxicity defined as grade 3-5 toxicity occurring between 270-540 days (i.e., 9-18 months) from the start of the protocol treatment as assessed by CTCAE v3.0

Secondary Outcome Measures :
  1. Acute severe GU and GI toxicity defined as grade 3-5 toxicity occurring prior to 270 days from the start of protocol treatment as assessed by CTCAE v3.0
  2. Non-GU and non-GI toxicity
  3. Biochemical failure defined as a rise in the PSA level by more than 2 ng/mL above the lowest level (nadir) achieved after treatment
  4. Overall survival
  5. Disease-specific survival
  6. Clinical progression including local/regional and distant relapse

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate

    • Stage T1a, T1b, T1c disease
    • Stage T2a or T2b
  • No direct evidence of regional or distant metastases
  • No T2c, T3, or T4 tumors
  • Gleason score ≤ 7
  • Must meet the following criteria:

    • Prostate-specific antigen (PSA) ≤ 20 ng/mL prior to starting hormonal therapy (if given) for patients with a Gleason score of 2-6
    • PSA ≤ 15 ng/mL prior to starting hormonal therapy (if given) for patients with a Gleason score of 7
    • Risk of pelvic lymph node involvement < 20% according to Roach formula
  • Ultrasound-based volume estimation of the prostate gland ≤ 60 g


  • Zubrod performance status 0-2
  • Fertile patients must use effective contraception
  • No prior invasive malignancy, except for nonmelanoma skin cancer, unless disease-free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are allowed)
  • No significant urinary obstructive symptoms

    • American Urological Association (AUA) score of ≤ 15 (alpha blockers allowed)
  • No history of inflammatory colitis (including Crohn disease and ulcerative colitis)
  • No history of significant psychiatric illness
  • No severe, active comorbidity including any of the following:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
    • Transmural myocardial infarction within the past 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

      • Laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
    • AIDS (based on current CDC definition) or other immunocompromising condition

      • HIV testing is not required for entry into this protocol


  • See Disease Characteristics
  • More than 9 months since prior hormonal therapy as neoadjuvant therapy or to downsize the prostate gland
  • No prior pelvic radiotherapy
  • No prior chemotherapy or surgery for prostate cancer
  • No prior transurethral resection of the prostate (TURP) or cryotherapy to the prostate
  • No plans for other concurrent post-treatment, adjuvant, antineoplastic therapy including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy as part of the treatment for prostate cancer

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 identifier (NCT number): NCT00547339

United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a    866-460-4673; 214-648-7097      
Sponsors and Collaborators
Simmons Cancer Center
Study Chair: Robert D. Timmerman, MD Simmons Cancer Center

Responsible Party: Regulatory Affairs Associate, University of Texas Southwestern Medical Center at Dallas Identifier: NCT00547339     History of Changes
Other Study ID Numbers: CDR0000571546
First Posted: October 22, 2007    Key Record Dates
Last Update Posted: February 21, 2011
Last Verified: June 2010

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer

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