Prostate Cancer
Conditions
Keywords
Prostate, Radiation, Radical prostatectomy, 09-013
Brief summary
This study is being done to test the safety of a single high-dose of radiation therapy before radical prostatectomy (removal of the prostate). The investigators want to find out what effects, good and/or bad, the radiation will have on men undergoing prostatectomy. The investigators are especially interested in men who are at risk for having cancer cells that have spread outside the prostate.
Interventions
RADIATIONHigh-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy
A baseline DCE-MRI will be obtained prior to the day of radiotherapy treatment. Immediately following the delivery of radiotherapy another DCE-MRI will be performed to assess for perfusion changes in the prostate resulting from irradiation. RP will be completed within 6 weeks (+ 2 weeks) of radiation and the RP specimen will be assessed for radiation treatment effect and other pathologic parameters (including surgical margin status) by a dedicated genitourinary pathologist. Following RP, participants will follow-up with their surgeon every 3 months for one year, with visits alternating between the urologist and the radiation oncologist. After the first year follow-up will occur at 6 month intervals until the patient is 3 years out from surgery.
Sponsors
Memorial Sloan Kettering 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
* Biopsy-proven prostate cancer verified at MSKCC. The biopsy will include a minimum of 10 cores * Radical Prostatectomy (RP) chosen as the therapeutic method * The size of the prostate will be \< 70 cc by transrectal ultrasound or endorectal MRI imaging * No radiographic evidence of lymph node metastases, bone metastases or soft tissue disease * Risk of extraprostatic cancer of \> 40% based on the MSKCC surgical nomogram * Age \> or = to 18 years * KPS \> or = to 80 * Able to tolerate immobilization cradle positioning
Exclusion criteria
* Allergic reaction to intravenous CT contrast (if premedicated, pt will not be excluded) * Prior radiation to the planned target region * Patients receiving concurrent chemotherapy * Neoadjuvant hormonal therapy Luteinizing-hormone-releasing hormone(LHRH)agonist and/or antiandrogen) * Prior transurethral resection of the prostate * Normal tissue directly overlying target precluding ability to limit the bowel, bladder, rectum or other tissue to less than or equal to 15-16 Gy dose constraints * Dominant prostatic lesion within 3 mm from the anterior rectal wall by imaging studies * Creatinine clearance \<60 ml/min/1.73m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the feasibility and safety of single-fraction image-guided intensity modulated radiotherapy (IG-IMRT). | 1 year | Given prior to radical prostatectomy (RP) in men at high risk for extraprostatic cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To analyze the changes in prostate perfusion induced by single-fraction IG-IMRT. | 1 before radiation simulation, 1 after radiation treatment | via dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) |
| To assess the long-term toxicity of intensity modulated radiotherapy (IG-IMRT) | weeks 3, 6, 9, 12, 18, 24, 30, and 36 months after RP | Given prior to radical prostatectomy (RP) with respect to urinary function, erectile function, and bowel function. |
| To assess the effect of IG-IMRT on the anticipated positive margin rate at the time of RP. | 1 year | — |
Countries
United States
Outcome results
None listed