NCT03233672

Hypo-fractionated Postoperative IMRT in Prostate Cancer

Hypofractionated Post-operative IMRT in Prostate Carcinoma: a Phase I/II Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: Male
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

To report the outcome of hypo-fractionated radiotherapy after radical prostatectomy (RP) for prostate cancer (PCa) using IMRT-SIB. 124 patients with PCa at high risk of relapse after RP or diagnosis of biochemical relapse were included. Patients received 62.5 Gy to the prostate bed (PB) and 45 Gy to pelvis nodes in 25 fractions. Androgen suppressive therapy was prescribed based on NCCN risk categories. Median follow-up was 30 months.

Detailed description

To report the outcome of hypo-fractionated radiation therapy after radical prostatectomy (RP) for prostate cancer (PCa) using intensity-modulated radiation treatment with simultaneous integrated boost (IMRT-SIB). One hundred and twenty-four patients with PCa at high risk of relapse after RP or diagnosis of biochemical relapse were included in this phase II study (adjuvant: 106 patients, salvage: 18 patients). All patients received 62.5 Gy to the prostate bed (PB) and 45 Gy to pelvis nodes in 25 fractions. Androgen suppressive therapy was prescribed based on NCCN risk categories. Acute and late toxicities were recorded and evaluated according to RTOG (Radiation Therapy Oncology Group) criteria and RTOG-EORTC (European Organization for Research and Treatment of Cancer) scale, respectively. Median follow-up was 30 months (13-92).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Hypo-fractionated postoperative IMRT-SIB	intensity-modulated radiation treatment with simultaneous integrated boost

Timeline

• Start date: 2007-09-18
• Primary completion: 2010-09-18
• Completion: 2014-09-18
• First posted: 2017-07-28
• Last updated: 2018-03-06