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

Prostate Cancer Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01704027
• Other study ID #: 2012-A00694-39
• Status: Terminated
• Phase: Phase 2
• First received: October 2, 2012
• Last updated: September 17, 2014
• Start date: October 2012

Study information

• Verified date: September 2014
• Source: Centre Georges Francois Leclerc
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Centre Georges-François Leclerc	Dijon	Burgundy

Sponsors (1)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To evaluate the late urinary and rectal toxicities		for each patient every 6 months after the end of radiotherapy up to 5 years.	Yes
Secondary	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.	No
Secondary	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.	No
Secondary	To evaluate the specific survival		for each patient from inclusion up to 5 years after the end of radiotherapy.	No
Secondary	To evaluate the overall survival		for each patient from inclusion up to 5 years after the end of radiotherapy.	No
Secondary	To evaluate the quality of life		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.	No