This is a single-arm prospective non-randomized, non-blinded trial to assess the safety of neoadjuvant stereotactic body radiation therapy (SBRT) before surgery in high risk prostate cancer patients. Radiation therapy will be delivered over 5 treatment sessions for approximately 1.5 weeks total.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Delivered over 5 treatment sessions for approximately 1.5 weeks total.
Open, laparoscopic, or robotic radical prostatectomy and pelvic lymph node dissection to remove the prostate, seminal vesicles, and pelvic lymph nodes.
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Maximum Tolerated Dose (MTD) of Neoadjuvant SBRT
The MTD is defined as the SBRT dose that with radical prostatectomy induces dose-limiting toxicity in 28% of subjects or less.
Time frame: 6-week post-prostatectomy
Incidence of Urinary Incontinence
Urinary incontinence will be scored according to Common Toxicity Criteria for Adverse Events (CTCAE) v.4.0 (Grade 1 = Occasional, Grade 2 = Spontaneous, pads indicated, Grade 3 = Intervention indicated)
Time frame: up to one year post treatment
Incidence of Urinary Stricture
Urinary stricture, according to Common Toxicity Criteria for Adverse Events (CTCAE) v.4.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening, Grade 5 = death.)
Time frame: up to one year post treatment
Incidence of Urinary Bother
Urinary bother, according to Common Toxicity Criteria for Adverse Events (CTCAE) v.4.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening, Grade 5 = death.)
Time frame: up to one year post treatment
Rectal Toxicity
Rectal Toxicity, according to Common Toxicity Criteria for Adverse Events (CTCAE) v.4.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening, Grade 5 = death.)
Time frame: up to one year post treatment
Number of Patients with Positive Surgical Margins
Surgical specimens will be evaluated by the study pathologist to determine rate of margin positivity.
Time frame: 4-10 weeks post radiation therapy
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Number of Patients with Extracapsular Extension
Surgical specimens will be evaluated by the study pathologist to determine rate of extracapsular extension.
Time frame: 4-10 weeks post radiation therapy