A Phase I Dose-Escalation Study of Preoperative Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk, Localized Carcinoma of the Prostate
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 boost to the prostate and periprostatic tissue, for total doses
of 50.4 and 54 Gy, respectively. The patients will then undergo radical prostatectomy
between 4-8 weeks after completion of radiation.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate number of patients who are able to undergo surgery after preoperative radiation therapy.
Mitchell S. Anscher, M.D.
Virginia Commonwealth University
United States: Institutional Review Board
|Virginia Commonwealth University||Richmond, Virginia|