Tailored postoperative treatment of prostate cancer: final results of a phase I/II trial

Giovanna Mantini, Giambattista Siepe, Anna Rita Alitto, Milly Buwenge, Nam P. Nguyen, Andrea Farioli, Riccardo Schiavina, Francesco Catucci, Francesco Deodato, Bruno Fionda, Vincenzo Frascino, Gabriella Macchia, Maria Ntreta, Gilbert D. A. Padula, Alessandra Arcelli, Silvia Cammelli, Giuseppe Zanirato Rambaldi, Savino Cilla, Vincenzo Valentini, Alessio G. Morganti

Risultato della ricerca: Contributo in rivistaArticolo in rivista

1 Citazioni (Scopus)


Backgroud: The European Organization for Research and Treatment of Cancer (EORTC) trial 22,911 reported 74% 5-year biochemical disease-free survival (bDFS) in patients with prostate carcinoma treated with radical prostatectomy (RP) followed by postoperative radiotherapy (RT). This study aimed to improve these outcomes by using a combined-intensified-modulated-adjuvant treatment, including RT and hormone therapy (HT) after RP. Materials and methods: This phase I/II trial treatment was designed to improve 5-year bDFS from ~ 75 to 90%. Patients were consecutively enrolled using the following inclusion criteria: age < 80 years, histological diagnosis of prostate adenocarcinoma without known metastases, stage pT2-4N0-1, and Eastern Cooperative Oncology Group performance status of 0–2. All patients had at least one of these pathologic features: capsular perforation, positive surgical margins, seminal vesicle invasion, and pelvic lymph nodes involvement. A minimum dose of 64.8 Gy to the tumor bed was delivered in all patients. Depending on tumor characteristics at diagnosis, patients received a higher dose (70.2 Gy; 85.4%) and/or prophylactic pelvic lymph nodes irradiation (57.7%) and/or HT (69.1%). Biochemical relapse was defined as two consecutive rising prostate-specific antigen (PSA) values > 0.2 ng/ml. Results: A total of 123 patients were enrolled in the study and completed the scheduled treatment. Median preoperative and postoperative PSA were: 8.8 and 0.06 ng/mL, respectively. The percentages of patients with pathologically involved nodes and positive resection margins were: 14.6% and 58.5%, respectively. With a median follow-up of 67 months (range: 37–120 months), the actuarial 5-year bDFS, local control, metastasis-free survival, and overall survival (OS) were: 92.9%, 98.7%, 96.1%, and 95.1%, respectively. Conclusion: A higher 5-year bDFS (92.9%) was recorded compared to studies based on standard adjuvant RT, even though patients with nodal disease and detectable postoperative PSA were enrolled. Clinical end points, as long-term disease-free survival and OS, will require further assessments. (ClinicalTrials.gov: NCT03169933).
Lingua originaleEnglish
pagine (da-a)564-572
Numero di pagine9
RivistaProstate Cancer and Prostatic Diseases
Stato di pubblicazionePubblicato - 2018


  • Aged
  • Combined Modality Therapy
  • Follow-Up Studies
  • Humans
  • Lymph Nodes
  • Magnetic Resonance Imaging
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Postoperative Care
  • Prognosis
  • Prostatic Neoplasms
  • Tomography, X-Ray Computed
  • Treatment Outcome


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