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

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ClinicalTrials.gov Identifier: NCT01704027
Recruitment Status : Terminated (termination of the trial after interim analysis. the main criterion could not be reached)
First Posted : October 11, 2012
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Simultaneous integrated boost intensity-modulated arctherapy Drug: Androgen deprivation Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : October 2012
Actual Primary Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. To evaluate the specific survival [ Time Frame: for each patient from inclusion up to 5 years after the end of radiotherapy. ]
  5. To evaluate the overall survival [ Time Frame: for each patient from inclusion up to 5 years after the end of radiotherapy. ]
  6. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704027


Locations
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France
Centre Georges-François Leclerc
Dijon, Burgundy, France, 21079
Sponsors and Collaborators
Centre Georges Francois Leclerc
Investigators
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Principal Investigator: Etienne MARTIN, MD Centre Georges-François Leclerc
More Information
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Responsible Party: Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier: NCT01704027     History of Changes
Other Study ID Numbers: 2012-A00694-39
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014
Keywords provided by Centre Georges Francois Leclerc:
Localized
High risk
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Ascorbic Acid
Methyltestosterone
Androgens
Estrogens, Conjugated (USP)
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents