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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.


Phase 2
18 Years
80 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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.


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 ≤ 80 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 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

From start of radiotherapy to six months after the end of radiotherapy

Safety Issue:

Yes

Principal Investigator

Etienne MARTIN, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Georges-François Leclerc

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

2012-A00694-39

NCT ID:

NCT01704027

Start Date:

October 2012

Completion Date:

October 2023

Related Keywords:

  • Prostate Cancer
  • Localized
  • High risk
  • Prostatic Neoplasms

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