Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate
This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined
regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5
fractions) with androgen deprivation therapy (ADT) for 4 months total, 2 months before and 2
months after the hypofractionated radiation delivered.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
1) Assess the incidence of grade 3 or greater GU (genitourinary) and GI (gastrointestinal) toxicity with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.
Phuoc Tran, M.D.
The Johns Hopkins University School of Medicine
United States: Food and Drug Administration
|The Sidney Kimmel Comprehsive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231|