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

Centre Georges Francois Leclerc

Status and phase: Terminated; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Androgen deprivation; Radiation: Simultaneous integrated boost intensity-modulated arctherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01704027

2012-A00694-39

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Radiotherapy

Experimental group

Description:

Patient will receive a pelvic and prostatic simultaneous integrated boost intensity-modulated arctherapy (SIB-IMAT) in combination with three years of androgen deprivation

Treatment:

Drug: Androgen deprivation

Radiation: Simultaneous integrated boost intensity-modulated arctherapy