Multimodal treatment for high-risk prostate cancer with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel and long-term androgen deprivation therapy: Eesults of a prospective phase II trial

Andrea Guttilla, Roberto Bortolus, Gianluca Giannarini, Pirus Ghadjar, Fabio Zattoni, Michele Gnech, Vito Palumbo, Francesca Valent, Antonio Garbeglio, Filiberto Zattoni

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The optimal management of high-risk prostate cancer remains uncertain. In this study we assessed the safety and efficacy of a novel multimodal treatment paradigm for high-risk prostate cancer.Methods: This was a prospective phase II trial including 35 patients with newly diagnosed high-risk localized or locally advanced prostate cancer treated with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel-based chemotherapy and long-term androgen deprivation therapy. Primary endpoint was acute and late toxicity evaluated with the Common Terminology Criteria for Adverse Events version 3.0. Secondary endpoint was biochemical and clinical recurrence-free survival explored with the Kaplan-Meier method.Results: Acute gastro-intestinal and genito-urinary toxicity was grade 2 in 23% and 20% of patients, and grade 3 in 9% and 3% of patients, respectively. Acute blood/bone marrow toxicity was grade 2 in 20% of patients. No acute grade ≥4 toxicity was observed. Late gastro-intestinal and genito-urinary toxicity was grade 2 in 9% of patients each. No late grade ≥3 toxicity was observed. Median follow-up was 63 months (interquartile range 31-79). Actuarial 5-year biochemical and clinical recurrence-free survival rate was 55% (95% confidence interval, 35-75%) and 70% (95% confidence interval, 52-88%), respectively.Conclusions: In our phase II trial testing a novel multimodal treatment paradigm for high-risk prostate cancer, toxicity was acceptably low and mid-term oncological outcome was good. This treatment paradigm, thus, may warrant further evaluation in phase III randomized trials.

Original languageEnglish
Article number24
JournalRadiation Oncology
Volume9
Issue number1
DOIs
Publication statusPublished - Jan 14 2014

Keywords

  • Androgen deprivation therapy
  • Chemotherapy
  • Clinical trial
  • Docetaxel
  • Intensity-modulated
  • Phase II
  • Prostatectomy
  • Prostatic neoplasms
  • Radiotherapy
  • Toxicity

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging

Fingerprint Dive into the research topics of 'Multimodal treatment for high-risk prostate cancer with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel and long-term androgen deprivation therapy: Eesults of a prospective phase II trial'. Together they form a unique fingerprint.

Cite this