Hypo-fractionated Postoperative IMRT in Prostate Cancer

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Hypo-fractionated postoperative IMRT-SIB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hypo-fractionated postoperative IMRT-SIB<br>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<br>* intensity-modulated radiation treatment with simultaneous integrated boost<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of early treatment-emergent adverse events | adverse events after radiotherapy. Acute side effets were scored according to the Radiation Therapy Oncology Group (RTOG) scale. | < 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical relapse free survival | 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 | 5 years | 
| incidence of late treatment-emergent adverse events were assessed with Radiation | Late complications were assessed with delete Radiation Morbidity Scoring Scheme of the RTOG/European Organization for Research and Treatment of Cancer (EORTC) | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adjuvant, hypofractionation, IMRT, phase I-II, prostate neoplasms, radiotherapy