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

Research output: Contribution to journalArticle

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).

Original languageEnglish
Pages (from-to)564-572
Number of pages9
JournalProstate Cancer and Prostatic Diseases
Volume21
Issue number4
DOIs
Publication statusPublished - Nov 1 2018

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Disease-Free Survival
Prostatic Neoplasms
Prostatectomy
Survival
Radiotherapy
Therapeutics
Adjuvant Radiotherapy
Prostate
Hormones
Neoplasm Metastasis
Carcinoma
Research
Neoplasms

ASJC Scopus subject areas

  • Oncology
  • Urology
  • Cancer Research

Cite this

Mantini, G., Siepe, G., Alitto, A. R., Buwenge, M., Nguyen, N. P., Farioli, A., ... Morganti, A. G. (2018). Tailored postoperative treatment of prostate cancer: final results of a phase I/II trial. Prostate Cancer and Prostatic Diseases, 21(4), 564-572. https://doi.org/10.1038/s41391-018-0064-7

Tailored postoperative treatment of prostate cancer : final results of a phase I/II trial. / Mantini, Giovanna; Siepe, Giambattista; Alitto, Anna Rita; Buwenge, Milly; Nguyen, Nam P.; Farioli, Andrea; Schiavina, Riccardo; Catucci, Francesco; Deodato, Francesco; Fionda, Bruno; Frascino, Vincenzo; Macchia, Gabriella; Ntreta, Maria; Padula, Gilbert D.A.; Arcelli, Alessandra; Cammelli, Silvia; Rambaldi, Giuseppe Zanirato; Cilla, Savino; Valentini, Vincenzo; Morganti, Alessio G.

In: Prostate Cancer and Prostatic Diseases, Vol. 21, No. 4, 01.11.2018, p. 564-572.

Research output: Contribution to journalArticle

Mantini, G, Siepe, G, Alitto, AR, Buwenge, M, Nguyen, NP, Farioli, A, Schiavina, R, Catucci, F, Deodato, F, Fionda, B, Frascino, V, Macchia, G, Ntreta, M, Padula, GDA, Arcelli, A, Cammelli, S, Rambaldi, GZ, Cilla, S, Valentini, V & Morganti, AG 2018, 'Tailored postoperative treatment of prostate cancer: final results of a phase I/II trial', Prostate Cancer and Prostatic Diseases, vol. 21, no. 4, pp. 564-572. https://doi.org/10.1038/s41391-018-0064-7
Mantini, Giovanna ; Siepe, Giambattista ; Alitto, Anna Rita ; Buwenge, Milly ; Nguyen, Nam P. ; Farioli, Andrea ; Schiavina, Riccardo ; Catucci, Francesco ; Deodato, Francesco ; Fionda, Bruno ; Frascino, Vincenzo ; Macchia, Gabriella ; Ntreta, Maria ; Padula, Gilbert D.A. ; Arcelli, Alessandra ; Cammelli, Silvia ; Rambaldi, Giuseppe Zanirato ; Cilla, Savino ; Valentini, Vincenzo ; Morganti, Alessio G. / Tailored postoperative treatment of prostate cancer : final results of a phase I/II trial. In: Prostate Cancer and Prostatic Diseases. 2018 ; Vol. 21, No. 4. pp. 564-572.
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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).",
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T1 - Tailored postoperative treatment of prostate cancer

T2 - final results of a phase I/II trial

AU - Mantini, Giovanna

AU - Siepe, Giambattista

AU - Alitto, Anna Rita

AU - Buwenge, Milly

AU - Nguyen, Nam P.

AU - Farioli, Andrea

AU - Schiavina, Riccardo

AU - Catucci, Francesco

AU - Deodato, Francesco

AU - Fionda, Bruno

AU - Frascino, Vincenzo

AU - Macchia, Gabriella

AU - Ntreta, Maria

AU - Padula, Gilbert D.A.

AU - Arcelli, Alessandra

AU - Cammelli, Silvia

AU - Rambaldi, Giuseppe Zanirato

AU - Cilla, Savino

AU - Valentini, Vincenzo

AU - Morganti, Alessio G.

PY - 2018/11/1

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N2 - 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).

AB - 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).

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