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Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00547339
First received: October 19, 2007
Last updated: February 18, 2011
Last verified: June 2010
  Purpose

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 Intervention Phase
Prostate Cancer
Radiation: stereotactic body radiation therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Masking: 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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) or a dose of 50 Gy total (whichever comes first) [ Designated as safety issue: Yes ]
  • 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 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: Yes ]
  • Non-GU and non-GI toxicity [ Designated as safety issue: Yes ]
  • Biochemical failure defined as a rise in the PSA level by more than 2 ng/mL above the lowest level (nadir) achieved after treatment [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Disease-specific survival [ Designated as safety issue: No ]
  • Clinical progression including local/regional and distant relapse [ Designated as safety issue: No ]

Estimated Enrollment: 97
Study Start Date: July 2006
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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)

Secondary

  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
  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: NCT00547339

Locations
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
Investigators
Study Chair: Robert D. Timmerman, MD Simmons Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Regulatory Affairs Associate, University of Texas Southwestern Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT00547339     History of Changes
Other Study ID Numbers: CDR0000571546, SCCC-062006-010, SCCC-0604122, UMN-2006UC048
Study First Received: October 19, 2007
Last Updated: February 18, 2011
Health Authority: Unspecified

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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 23, 2014