Hypo-fractionated Postoperative IMRT in Prostate Cancer

NCT ID: NCT03233672

Last Updated: 2018-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-18
• Study Completion Date: 2014-09-18

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypo-fractionated postoperative IMRT-SIB

All patients underwent combined, intensified and modulated radiotherapy for five days a week with the following doses: 62.5 Gy to the prostate bed and 45 Gy to pelvis nodes in 25 fractions.

Group Type: OTHER

Hypo-fractionated postoperative IMRT-SIB

Intervention Type: RADIATION

intensity-modulated radiation treatment with simultaneous integrated boost

Interventions

Hypo-fractionated postoperative IMRT-SIB

intensity-modulated radiation treatment with simultaneous integrated boost

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• > 18 years
• prior radical prostatectomy with or without lymphadenectomy
• high-risk patients (positive surgical margins, and/or extracapsular extension, and/or seminal vescicle invasion, and/or probability of nodal metastasis > 7% calculated by the Roach formula after pelvic lymph node dissection with ≤ 13 nodes removed, and/or presence of any positive pelvic nodes) or patients with biochemical relapse (initial post-surgery serum PSA equal or above 0.2 ng/mL with a second confirmatory PSA of the same value)
• ECOG performance status 0-1
• adequate bone marrow function (hemoglobin concentration > 8 g/dl, white blood cell count > 3,000/ mm³, platelet count > 75,000/ mm³)
• pre-treatment computed tomography (CT) scan or magnetic resonance imaging (MRI) of the abdomen and pelvis
• bone scan
• informed consent

Exclusion Criteria

• prior pelvic radiotherapy
• distant metastases
• macroscopic residual tumor
• pelvic or para-aortic nodes at re-evaluation imaging after surgery
• secondary malignancies
• genetic syndromes of hyper-radio-sensitivity
• chronic inflammatory bowel disease
• previously treated with androgen deprivation therapy
• previously treated with chemotherapy for prostate cancer

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: collaborator

University of Bologna

OTHER

Sponsor Role: collaborator

Howard University

OTHER

Sponsor Role: collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Alessio Giuseppe Morganti

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessio G Morganti, MD

Role: STUDY_DIRECTOR

Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy

Other Identifiers

Iside-PP-2

Identifier Type: -

Identifier Source: org_study_id