Three-dimensional conformal radiation therapy in localized carcinoma of the prostate: interim report of a phase 1 dose-escalation study.

Acute morbidity, late complications and tumor response were evaluated in 324 prostate cancer patients treated with 3-dimensional conformal radiation therapy in a phase I dose-escalation study. This radiotherapy technique targeted the prostate and seminal vesicles but effectively excluded the surrounding normal tissues. The minimum tumor dose was 64.8 to 66.6 Gy. in 87 patients, 70.2 Gy. in 138, 75.6 Gy. in 69 and 81.0 Gy. in 30. The treatment was well tolerated with minimal acute morbidity, observed in 15% of the patients who required medication for relief of rectal symptoms and in 34% for urinary symptoms. Two patients (0.6%) to date have had grades 3 and 4 late complications (Radiation Therapy Oncology Group morbidity grading system). The 3-year actuarial probability of survival with a normal serum prostate specific antigen level was 97% for patients with stages T1c and T2a, 86% with stage T2b, 60% with stage T2c and 43% with stage T3 disease. A multivariate analysis demonstrated that initial prostate specific antigen (20 ng./ml. or less versus more than 20 ng./ml.), stage (T2c or less versus T3) and Gleason score (6 or less versus 7 or more) were each significant independent variables that affected subsequent chemical relapse. The acute and long-term toxicities have been less compared with traditional treatment techniques. After the maximal tolerable dose with 3-dimensional conformal radiotherapy is established, future studies will test whether high dose conformal therapy has the potential to improve local tumor control and survival of patients with localized prostatic carcinoma.