Clinical trial NCT01163448: Feasibility and Safety Study Using Preoperative High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy at High-Risk for Extraprostatic Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: Prostate
Radiation
Radical prostatectomy
09-013
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-07-15
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: To assess the feasibility and safety of single-fraction image-guided intensity modulated radiotherapy (IG-IMRT).
timeFrame: 1 year
Secondary outcomes:
measure: To analyze the changes in prostate perfusion induced by single-fraction IG-IMRT.
timeFrame: 1 before radiation simulation, 1 after radiation treatment
measure: To assess the long-term toxicity of intensity modulated radiotherapy (IG-IMRT)
timeFrame: weeks 3, 6, 9, 12, 18, 24, 30, and 36 months after RP
measure: To assess the effect of IG-IMRT on the anticipated positive margin rate at the time of RP.
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: James Eastham, MD
role: PRINCIPAL_INVESTIGATOR
References: