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

Primary Purpose

Prostate Cancer

Status

Terminated

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Simultaneous integrated boost intensity-modulated arctherapy

Androgen deprivation

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Localized, High risk

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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,
Signed informed consent.

Exclusion Criteria:

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.

Sites / Locations

Centre Georges-François Leclerc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To evaluate the late urinary and rectal toxicities

Evaluate the 5-year biochemical-free survival

Evaluate the metastase-free survival

To evaluate the specific survival

To evaluate the overall survival

To evaluate the quality of life

Full Information

NCT ID

NCT01704027

First Posted

October 2, 2012

Last Updated

September 17, 2014

Sponsor

Centre Georges Francois Leclerc

1. Study Identification

Unique Protocol Identification Number

NCT01704027

Brief Title

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

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Terminated

Why Stopped

termination of the trial after interim analysis. the main criterion could not be reached

Study Start Date

October 2012 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Georges Francois Leclerc

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Localized, High risk

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radiotherapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Simultaneous integrated boost intensity-modulated arctherapy

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Androgen deprivation

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

To evaluate the late urinary and rectal toxicities

Time Frame

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

Title

Evaluate the 5-year biochemical-free survival

Time Frame

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.

Title

Evaluate the metastase-free survival

Time Frame

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.

Title

To evaluate the specific survival

Time Frame

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

Title

To evaluate the overall survival

Time Frame

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

Title

To evaluate the quality of life

Time Frame

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.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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, Signed informed consent. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Etienne MARTIN, MD

Organizational Affiliation

Centre Georges François Leclerc

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Georges-François Leclerc

City

Dijon

State/Province

Burgundy

ZIP/Postal Code

21079

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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