Safety Study of Pelvic and Prostatic SIB-IMRT With Long-term Androgen Deprivation for High Risk Localized Prostate Cancer

September 17, 2014 updated by: Centre Georges Francois Leclerc

Prospective Phase II Study Evaluating the Feasibility of a Conformational Pelvic and Prostatic Radiotherapy With Simultaneous Integrated Boost Modulated-intensity Arctherapy (SIB-IMAT) in Combination With Long Term Androgen Deprivation for High Risk Localized Prostate Cancer.

The purpose of this study is to evaluate the incidence of urinary and rectal acute side effects of a pelvic and prostatic intensity-modulated arctherapy with simultaneous integrated boost (SIB-IMRT)combined with long-term androgen deprivation for patients with high risk localized prostate cancer

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Burgundy
      • Dijon, Burgundy, France, 21079
        • Centre Georges-Francois Leclerc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Histologically confirmed adenocarcinoma of the prostate

  2. High risk localized adenocarcinoma defined by at least one of the following criteria:

    • Clinical stage T2c, T3 or T4
    • Gleason score ≥ 8
    • Prostate-specific antigen (PSA)≥ 20 ng/ml and ≤ 100 ng/ml
  3. Patient cN0, pN0 or Nx (negative lymphadenectomy or no lymphadenectomy)
  4. No pelvic adenopathy ≥ 15 mm on CT or MRI,
  5. Absence of bone and/or visceral metastasis
  6. Androgen deprivation beginning no later than the day of radiotherapy and up to six months before irradiation
  7. Absence of prior pelvic radiotherapy,
  8. Absence of surgical treatment of prostate cancer except transurethral resection performed within 4 months minimum before radiotherapy,
  9. Age ≥ 18 years and ≤ 85 years
  10. ECOG performance status ≤ 1,
  11. Estimated life expectancy > 5 years
  12. Membership of a social security system,
  13. Signed informed consent.

Exclusion Criteria:

  1. Prostate cancer histology other than adenocarcinoma,
  2. pN1 patients (lymph node dissection after histologically proven)
  3. PSA > 100 ng/ml
  4. History of cancer within 5 years prior to trial entry (with the exception of basal cell carcinoma skin)
  5. Patient with severe hypertension uncontrolled by appropriate treatment (≥ 160 mm Hg systolic and / or ≥ 90 mm Hg diastolic)
  6. Contra-indication for pelvic irradiation (eg scleroderma, chronic inflammatory disease of the digestive tract, etc ...)
  7. Contra-indication to agonists or antagonists of LH-RH
  8. Bilateral hip prosthesis,
  9. Patients already included in another clinical trial with an experimental molecule,
  10. Persons deprived of liberty or under guardianship
  11. Unable to undergo medical test for geographical, social or psychological.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiotherapy
Patient will receive a pelvic and prostatic simultaneous integrated boost intensity-modulated arctherapy (SIB-IMAT) in combination with three years of androgen deprivation
Radiation: Simultaneous integrated boost intensity-modulated arctherapy

Three dose levels will be delivered at each fraction, 5 days a week, 30 fractions :

  • Pelvis : 55,5 Gy (1,85 Gy/fr)
  • Seminal vesicles : 66 Gy (2,2 Gy/fr)
  • Prostate : 72 Gy (2,4 Gy/fr)
Drug: Androgen deprivation
Patients will received androgen deprivation for a maximum of three years. This treatment can start six months before radiotherapy and at least the day one of radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Acute urinary and rectal toxicities as a Measure of treatment specific Safety and Tolerability
Time Frame: From start of radiotherapy to six months after the end of radiotherapy
Acute urinary and rectal toxicities will be assessed according to the NCI CTCAE v4.0 quotation each week during radiotherapy treatment period up to six months after the end of the radiotherapy treatment period.
From start of radiotherapy to six months after the end of radiotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the late urinary and rectal toxicities
Time Frame: for each patient every 6 months after the end of radiotherapy up to 5 years.
for each patient every 6 months after the end of radiotherapy up to 5 years.
Evaluate the 5-year biochemical-free survival
Time Frame: for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years.
for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years.
Evaluate the metastase-free survival
Time Frame: for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years.
for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years.
To evaluate the specific survival
Time Frame: for each patient from inclusion up to 5 years after the end of radiotherapy.
for each patient from inclusion up to 5 years after the end of radiotherapy.
To evaluate the overall survival
Time Frame: for each patient from inclusion up to 5 years after the end of radiotherapy.
for each patient from inclusion up to 5 years after the end of radiotherapy.
To evaluate the quality of life
Time Frame: inclusion day, from zero day up to 7 day after the end of radiotherapy, 6 weeks after the end of the radiotherapy, 3 months after the end of the radiotherapy, every 6 months after the end of radiotherapy up to 5 years.
inclusion day, from zero day up to 7 day after the end of radiotherapy, 6 weeks after the end of the radiotherapy, 3 months after the end of the radiotherapy, every 6 months after the end of radiotherapy up to 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Georges Francois Leclerc

Investigators

  • Principal Investigator: Etienne MARTIN, MD, Centre Georges-Francois Leclerc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

October 2, 2012

First Submitted That Met QC Criteria

October 9, 2012

First Posted (Estimate)

October 11, 2012

Study Record Updates

Last Update Posted (Estimate)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A00694-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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