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

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??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).

SUBMITTER: Mantini G

PROVIDER: S-EPMC6283858 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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

Mantini Giovanna G Siepe Giambattista G Alitto Anna Rita AR Buwenge Milly M Nguyen Nam P NP Farioli Andrea A Schiavina Riccardo R Catucci Francesco F Deodato Francesco F Fionda Bruno B Frascino Vincenzo V Macchia Gabriella G Ntreta Maria M Padula Gilbert D A GDA Arcelli Alessandra A Cammelli Silvia S Rambaldi Giuseppe Zanirato GZ Cilla Savino S Valentini Vincenzo V Morganti Alessio G AG

Prostate cancer and prostatic diseases 20180723 4

<h4>Backgroud</h4>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.<h4>Materials and methods</h4>This phase I/II trial treatment wa ...[more]

PMID: 30038390

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

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

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