Dallas, Texas 75390


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.


Study summary:

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.


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


NCT ID:

NCT00547339


Primary Contact:

Study Chair
Robert D. Timmerman, MD
Simmons Cancer Center


Backup Contact:

N/A


Location Contact:

Dallas, Texas 75390
United States

Clinical Trials Office - Simmons Comprehensive Cancer Center a
Phone: 866-460-4673; 214-648-7097

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 17, 2017

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