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, 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

Abstract

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).

Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Consolidated Standards of Reporting Trials (CONSORT) diagram
Fig. 2
Fig. 2
actuarial biochemical progression-free survival
Fig. 3
Fig. 3
impact of Gleason Score on biochemical progression-free survival

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