Intensified Adjuvant Treatment of Prostate Carcinoma : Feasibility Analysis of a Phase III Trial

Abstract EN

Purpose.

To perform a preliminary feasibility acute and late toxicity evaluation of an intensified and modulated adjuvant treatment in prostate cancer (PCa) patients after radical prostatectomy.

Material and Methods.

A phase I/II has been designed.

Eligible patients were 79 years old or younger, with an ECOG of 0–2, previously untreated, histologically proven prostate adenocarcinoma with no distant metastases, pT2–4 N0-1, and with at least one of the following risk factors: capsular perforation, positive surgical margins, and seminal vesicle invasion.

All patients received a minimum dose on tumor bed of 64.8 Gy, or higher dose (70.2 Gy; 85.4%), according to the pathological stage, pelvic lymph nodes irradiation (57.7%), and/or hormonal therapy (69.1%).

Results.

123 patients were enrolled and completed the planned treatment, with good tolerance.

Median follow-up was 50.6 months.

Grade 3 acute toxicity was only 2.4% and 3.3% for genitourinary (GU) and gastrointestinal (GI) tract, respectively.

No patient had late grade 3 GI toxicity, and the GU grade 3 toxicity incidence was 5.8% at 5 years.

5-year BDSF was 90.2%.

Conclusions.

A modulated and intensified adjuvant treatment in PCa was feasible in this trial.

A further period of observation can provide a complete assessment of late toxicity and confirm the BDSF positive results.