Login to Access Video or Poster Abstract: MP53-14
Sources of Funding: None

Introduction

To evaluate the safety and oncologic outcomes of adjuvant chemo (CHT), high-dose intensity-modulated radiation therapy (IMRT) and long-term androgen deprivation (ADT) therapy following radical prostatectomy (RP) and extended lymphadenectomy (PLND) in high risk prostate cancer patients.

Methods

Data of patients were collected in prospectively maintained database after IRB approval. Inclusion criteria of the study were: 1) high-risk localized (PSA level ≥20 ng/ml or clinical stage T2c or Gleason score ≥8) or locally advanced (clinical stage T3 or N+, any PSA level, any Gleason score) prostate cancer after RP and PLND 2) patients suitable to receive CHT and RT after surgery. Exclusion criteria were: 1) uncontrolled chronic disease; severe infection; peripheral neuropathy or prior malignancy within the last 5 years before study entry; 2) prior CHT, pelvic RT or local treatments for prostate cancer. Adjuvant IMRT with concurrent Docetaxel and long-term ADT were stared after 3-6 months form surgery. IMRT was performed in 4 to 6 field technique with 15-to 18-MV. Docetaxel was administered in a standard 1-hour intravenous weekly dose (30 mg if body surface area <1.8 m2 and 40 mg if body surface area ≥1.8 m2) for 6-7 weeks. ADT was maintained for 2 years. Acute and late toxicity were evaluated with the Common Terminology Criteria for Adverse Events version 3.0. Biochemical and clinical recurrence-free survival were explored with the Kaplan-Meier method.

Results

Overall 42 patients were included in the study. Acute Genito-Urinary (GU) toxicity was observed with grade I, II and III in 4 (9.5%), 2 (4.8%), and 1 (2.3%) patients, respectively. Acute Gastro-Intestinal (GI) toxicity was found found with grade I and II in 12 (29.3%) and 3 (7.2%), respectively. In those patients with acute toxicity, concomitant GU and GI toxicity occurred in 3 (7.2%) cases. No acute grade ≥IV toxicity was detected. A residual GU grade I toxicity was present only in 1 patient. Allergy due to CHT has been evaluated in 3/42 (7.1%) patients. Continence (defined as absence of any urinary leak) after RP and post IMRT was achieved in 29 (69%) and 27 (64.3%), respectively. After a median follow up of 3.4 years, a PSA recurrence and clinical recurrence were observed in 7 (16.7%) and 4 (9.5%) patients. A 5-year biochemical and clinical recurrence-free survival rate were 70.7% and 84.0%, respectively. 5-year overall free survival was 93.6%. None of patients died for prostate cancer during follow up.

Conclusions

This phase II trial test a novel multimodal treatment paradigm for high-risk prostate cancer. Toxicity was acceptably low and long term oncological outcomes were good. Further studies are needed to compare this novel treatment paradigm to the standard of care.

Funding

None