Spots Global Cancer Trial Database for Phase II Trial of SBRT + or - IMRT in Treatment of Patients With Clinically Confined Prostate Adenocarcinoma

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Trial Identification

Brief Title: Phase II Trial of SBRT + or - IMRT in Treatment of Patients With Clinically Confined Prostate Adenocarcinoma

Official Title: A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) With or Without Intensity Modulated Radiation Therapy (IMRT) in the Treatment of Patients With Clinically Confined Prostate Adenocarcinoma

Study ID: NCT02339948

Conditions

Prostate Adenocarcinoma

Interventions

SBRT

Study Description

Brief Summary: Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a and PSA \<10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total of 40 Gy. Intermediate risk patients (T2b or PSA \>10 ng/ml orGleason Score 7) will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy.

Detailed Description: Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a and PSA \<10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total of 40 Gy. Intermediate risk patients (T2b or PSA \>10 ng/ml orGleason Score 7) will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy. All patients will be assessed for toxicity at periodic time points following completion of treatment.