Phase I Feasibility and Safety Study Using Preoperative High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy at High-Risk for Extraprostatic Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- To assess the feasibility and safety of single-fraction image-guided intensity modulated radiotherapy (IG-IMRT).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
High-Dose Single-Fraction Image-Guided Radiotherapy
This will assess the feasibility and safety of this approach in men at high-risk for extraprostatic prostate cancer undergoing RP. This initial trial has been designed in a manner intended to emphasize patient comfort and safety.
Intervention: High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy (Radiation)
Outcomes
Primary Outcomes
To assess the feasibility and safety of single-fraction image-guided intensity modulated radiotherapy (IG-IMRT).
Time Frame: 1 year
Given prior to radical prostatectomy (RP) in men at high risk for extraprostatic cancer.
Secondary Outcomes
- 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)
- To analyze the changes in prostate perfusion induced by single-fraction IG-IMRT.(1 before radiation simulation, 1 after radiation treatment)
- To assess the effect of IG-IMRT on the anticipated positive margin rate at the time of RP.(1 year)