Clinical trial NCT01704027: Safety Study of Pelvic and Prostatic SIB-IMRT With Long-term Androgen Deprivation for High Risk Localized Prostate Cancer
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Localized
High risk
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Number of Participants with Acute urinary and rectal toxicities as a Measure of treatment specific Safety and Tolerability
timeFrame: From start of radiotherapy to six months after the end of radiotherapy
Secondary outcomes:
measure: To evaluate the late urinary and rectal toxicities
timeFrame: for each patient every 6 months after the end of radiotherapy up to 5 years.
measure: Evaluate the 5-year biochemical-free survival
timeFrame: 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.
measure: Evaluate the metastase-free survival
timeFrame: 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.
measure: To evaluate the specific survival
timeFrame: for each patient from inclusion up to 5 years after the end of radiotherapy.
measure: To evaluate the overall survival
timeFrame: for each patient from inclusion up to 5 years after the end of radiotherapy.
measure: To evaluate the quality of life
timeFrame: 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.
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges-François Leclerc
state: Burgundy
Study officials:
affiliation: Centre Georges François Leclerc
name: Etienne MARTIN, MD
role: PRINCIPAL_INVESTIGATOR
References: