Prostate Cancer
Conditions
Brief summary
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.
Interventions
RADIATIONStereotactic Body Radiation Therapy
Delivered over 5 treatment sessions for approximately 1.5 weeks total.
PROCEDURERadical Prostatectomy
Open, laparoscopic, or robotic radical prostatectomy and pelvic lymph node dissection to remove the prostate, seminal vesicles, and pelvic lymph nodes.
Sponsors
University of Michigan Rogel Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have biopsy-confirmed adenocarcinoma of the prostate. * Subjects must have a negative bone scan. * Subjects must have one of the following risk factors: * PSA ≥20 and/or * Gleason score ≥8 and/or * Clinical or radiographic stage ≥T3a per AJCC (American Joint Committee on Cancer) 7th Edition Staging Manual and/or * Radiographic pelvic lymph node positive disease and/or * At least two out of four of the following: PSA (Prostate Specific Antigen) 10-19.9, GS (Gleason Score) = 3+4, clinical stage = T2b/T2c, ≥50% positive biopsy cores. * Subjects must freely sign informed consent to enroll in the study. * Subjects must be medically fit to undergo surgery determined by the PI. * Age ≥ 18 * KPS Karnofsky Performance Status (performance status is an attempt to quantify cancer patients' general well-being and activities of daily life, scores range from 0 to 100 where 100 represents perfect health and 0 represents death): ≥70. * No prior invasive malignancy in the past 3-years, except non-melanomatous skin cancer unless disease free for a minimum of 2 years. Carcinoma in-situ of the bladder or head and neck region is permissible. * Subjects must not have had prior pelvic radiation therapy, * Subjects must not have had prior androgen deprivation therapy in the past 6 months.
Exclusion criteria
* Metastatic disease as demonstrated by bone scan, CT scan or MRI (Magnetic Resonance Imaging) of the pelvis, or chest x-ray. * Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician. * History of prior pelvic radiation therapy. * History of androgen deprivation therapy within the past 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Neoadjuvant SBRT | 6-week post-prostatectomy | The MTD is defined as the SBRT dose that with radical prostatectomy induces dose-limiting toxicity in 28% of subjects or less. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Urinary Stricture | up to one year post treatment | 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.) |
| Incidence of Urinary Bother | up to one year post treatment | 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.) |
| Incidence of Urinary Incontinence | up to one year post treatment | 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) |
| Number of Patients with Positive Surgical Margins | 4-10 weeks post radiation therapy | Surgical specimens will be evaluated by the study pathologist to determine rate of margin positivity. |
| Number of Patients with Extracapsular Extension | 4-10 weeks post radiation therapy | Surgical specimens will be evaluated by the study pathologist to determine rate of extracapsular extension. |
| Rectal Toxicity | up to one year post treatment | 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.) |
Countries
United States
Outcome results
None listed