Prostate Cancer Clinical Trial
Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
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.
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.
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
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
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There are 5 Locations for this study
Aurora Colorado, 80045, United States
Orlando Florida, 32806, United States
Minneapolis Minnesota, 55455, United States
Watertown South Dakota, 57201, United States
Dallas Texas, 75390, United States
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