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Hypo-fractionated Postoperative IMRT in Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypo-fractionated postoperative IMRT-SIB
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adjuvant, hypofractionation, IMRT, phase I-II, prostate neoplasms, radiotherapy

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Hypo-fractionated postoperative IMRT-SIB

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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
    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)

    Full Information

    First Posted
    July 26, 2017
    Last Updated
    March 5, 2018
    Sponsor
    IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Collaborators
    Catholic University of the Sacred Heart, University of Bologna, Howard University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03233672
    Brief Title
    Hypo-fractionated Postoperative IMRT in Prostate Cancer
    Official Title
    Hypofractionated Post-operative IMRT in Prostate Carcinoma: a Phase I/II Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 18, 2007 (Actual)
    Primary Completion Date
    September 18, 2010 (Actual)
    Study Completion Date
    September 18, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Collaborators
    Catholic University of the Sacred Heart, University of Bologna, Howard University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    adjuvant, hypofractionation, IMRT, phase I-II, prostate neoplasms, radiotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    124 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hypo-fractionated postoperative IMRT-SIB
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Radiation
    Intervention Name(s)
    Hypo-fractionated postoperative IMRT-SIB
    Intervention Description
    intensity-modulated radiation treatment with simultaneous integrated boost
    Primary Outcome Measure Information:
    Title
    incidence of early treatment-emergent adverse events
    Description
    adverse events after radiotherapy. Acute side effets were scored according to the Radiation Therapy Oncology Group (RTOG) scale.
    Time Frame
    < 90 days
    Secondary Outcome Measure Information:
    Title
    Biochemical relapse free survival
    Description
    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
    Time Frame
    5 years
    Title
    incidence of late treatment-emergent adverse events were assessed with Radiation
    Description
    Late complications were assessed with delete Radiation Morbidity Scoring Scheme of the RTOG/European Organization for Research and Treatment of Cancer (EORTC)
    Time Frame
    5 years
    Other Pre-specified Outcome Measures:
    Title
    First evidence of any pelvic recurrence
    Description
    First evidence of any pelvic recurrence
    Time Frame
    5 years
    Title
    Metastasis-free survival
    Description
    The first evidence of any extrapelvic recurrence of disease
    Time Frame
    5 years

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alessio G Morganti, MD
    Organizational Affiliation
    Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Hypo-fractionated Postoperative IMRT in Prostate Cancer

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