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

NCT01704027 | Terminated Phase 2

• 1 other identifier: 2012-A00694-39
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer

Keywords

Localized; High risk

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Acute urinary and rectal toxicities as a Measure of treatment specific Safety and Tolerability

  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 Outcomes (6)

• To evaluate the late urinary and rectal toxicities

  for each patient every 6 months after the end of radiotherapy up to 5 years.

• Evaluate the 5-year biochemical-free survival

  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

  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

  for each patient from inclusion up to 5 years after the end of radiotherapy.

• To evaluate the overall survival

  for each patient from inclusion up to 5 years after the end of radiotherapy.

Study Arms (1)

Radiotherapy

EXPERIMENTAL

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; Drug: Androgen deprivation

Interventions

Simultaneous integrated boost intensity-modulated arctherapy RADIATION

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)

Radiotherapy

Androgen deprivation DRUG

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.

Radiotherapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of the prostate
• 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
• Patient cN0, pN0 or Nx (negative lymphadenectomy or no lymphadenectomy)
• No pelvic adenopathy ≥ 15 mm on CT or MRI,
• Absence of bone and/or visceral metastasis
• Androgen deprivation beginning no later than the day of radiotherapy and up to six months before irradiation
• Absence of prior pelvic radiotherapy,
• Absence of surgical treatment of prostate cancer except transurethral resection performed within 4 months minimum before radiotherapy,
• Age ≥ 18 years and ≤ 85 years
• ECOG performance status ≤ 1,
• Estimated life expectancy \> 5 years
• Membership of a social security system,

You may not qualify if:

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

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Centre Georges-François Leclerc

Dijon, Burgundy, 21079, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Etienne MARTIN, MD

  Centre Georges François Leclerc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: October 11, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2014
• Last Updated: September 18, 2014

Record last verified: 2014-09

Locations

FR (1)