Status:
WITHDRAWN
Radiation Therapy Followed by Surgery in High-Risk, Localized Carcinoma of the Prostate
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Prostate Cancer
Eligibility:
MALE
Up to 69 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to assess the safety of four different doses of radiation therapy followed by to surgery to remove prostate tumor.
Detailed Description
Patients in Groups 1 and 2 will receive 39.6 Gy and 45 Gy (at 1.8 Gy/fraction), respectively, to the whole pelvis. Patients in Groups 3 and 4 will receive 45 Gy to the whole pelvis, followed by a boos...
Eligibility Criteria
Inclusion
- Subjects must have biopsy-confirmed adenocarcinoma of the prostate.
- Subjects must have a negative bone scan.
- Subjects must have "high-risk" prostate cancer, defined as:
- A. PSA \>/= 20, and/or B. Gleason Score (GS) \>/= 8, and/or C. Clinical stage T3 disease per AJCC Staging Manual, 6th edition; or D. At least two out of three of the following: PSA 10-19.9, GS = 7, or clinical stage = T2b / T2c.
- Subjects must be medically fit to undergo surgery as determined by treating urologist.
- Subjects must be under 70 years of age.
- KPS must be \>/= 80.
- Subjects must not have a synchronous primary tumor, or a previous cancer unless disease free for \>/= 5 years.
- Subjects must not have had prior pelvic radiation therapy, chemotherapy, or androgen deprivation.
- Subjects must freely sign informed consent to enroll in the study.
Exclusion
- Metastatic disease as demonstrated by bone scan, CT scan or MRI of the pelvis, or chest x-ray.
- Pathologically documented positive pelvic lymph nodes. If Pre-operative CT scan or MRI (ordered at the discretion of the treating physicians) demonstrates lymph nodes which are suspicious for involvement, then biopsy must be undertaken and nodes proven negative before patient can enroll on this trial.
- Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
- History of prior pelvic radiation therapy.
- History of androgen deprivation therapy or chemotherapy.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00691977
Start Date
September 1 2007
End Date
December 1 2009
Last Update
April 24 2013
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23219