Spots Global Cancer Trial Database for Preoperative Radiation Therapy for High Risk Prostate Cancer
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Trial Identification
Brief Title: Preoperative Radiation Therapy for High Risk Prostate Cancer
Official Title: A Phase I Dose-Escalation Study of Preoperative Radiation Therapy Followed by Radical Prostatectomy in Patients With High Risk, Localized Carcinoma of the Prostate
Study ID: NCT01041326
Conditions
Study Description
Brief Summary: This is a Phase I dose-escalation study of moderate dose radiation therapy prior to radical prostatectomy for patients with high-risk localized disease. Its hypothesis is that such treatment will be well tolerated with similar side effect profile as surgery alone. Patients in Groups 1 and 2 will receive 39.6 Gy and 45 Gy (at 1.8 Gy/fx), respectively, to the whole pelvis. Patients in Groups 3 and 4 will receive 45 Gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 50.4 and 54 Gy, respectively. The patient will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Duke University Medical Center, Durham, North Carolina, United States
Virginia Commonwealth University, Richmond, Virginia, United States
Contact Details
Name: Bridget F Koontz, MD
Affiliation: Duke University
Role: PRINCIPAL_INVESTIGATOR
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