Hypo-fractionated Postoperative IMRT in Prostate Cancer

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other)

Overall Status

Completed

CT.gov ID

NCT03233672

Collaborator

Catholic University of the Sacred Heart (Other), University of Bologna (Other), Howard University (Other)

124

Enrollment

Arm

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Radiation: Hypo-fractionated postoperative IMRT-SIB	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 18, 2007

Actual Primary Completion Date :

Sep 18, 2010

Actual Study Completion Date :

Sep 18, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Radiation: Hypo-fractionated postoperative IMRT-SIB intensity-modulated radiation treatment with simultaneous integrated boost

Arm

Intervention/Treatment

Other: 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.

Radiation: Hypo-fractionated postoperative IMRT-SIB

intensity-modulated radiation treatment with simultaneous integrated boost

Outcome Measures

Primary Outcome Measures

incidence of early treatment-emergent adverse events [< 90 days]
adverse events after radiotherapy. Acute side effets were scored according to the Radiation Therapy Oncology Group (RTOG) scale.

Secondary Outcome Measures

Biochemical relapse free survival [5 years]
Survival free from increase of PSA livel exceeding 0.2 ng/mL for those with post surgical PSA livel of 0.2 ng/mL or lower, and as two consecutive PSA increases for patients with a postsurgical PSA livel of > 0.2 ng/mL
incidence of late treatment-emergent adverse events were assessed with Radiation [5 years]
Late complications were assessed with delete Radiation Morbidity Scoring Scheme of the RTOG/European Organization for Research and Treatment of Cancer (EORTC)

Other Outcome Measures

First evidence of any pelvic recurrence [5 years]
First evidence of any pelvic recurrence
Metastasis-free survival [5 years]
The first evidence of any extrapelvic recurrence of disease

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Catholic University of the Sacred Heart
University of Bologna
Howard University

Investigators

Study Director: Alessio G Morganti, MD, Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy