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Hypofractionated Intensity Modulated Radiation Therapy Plus Hormonal Therapy in Patients With High Risk Prostate Cancer

Primary Purpose

High Risk Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
IMRT Technique
Sponsored by
Sergio Faria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Risk Prostate Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • pathologically proven diagnosis of adenocarcinoma of the prostate meeting one of the following conditions:
  • Clinical Stage >T3 or
  • Gleason Score 8 or higher, or
  • PSA level >20ng/ml
  • Study entry PSA must be obtained within 6 weeks prior to protocol entry
  • ECOG <2
  • Age >18
  • History and physical examination within 3 months
  • Bone scan and CT scan of the abdomen and pelvis within 3 months with no evidence of bone metastases and no pelvic lymph nodes larger than 1.0cm, unless biopsy negative.
  • CBC with differential within 6 weeks prior to protocol entry
  • Absolute neutrophil count >2000cells/mm3
  • Hemoglobin >8.0 g/dl (the use of transfusion to increase the Hg is acceptable)
  • Testosterone level within 6 weeks of protocol entry
  • Liver function tests
  • Signed informed consent
  • Prior use of hormonal therapy for prostate cancer is acceptable if less than 2 months.

Exclusion Criteria:

  • Prior use of hormonal therapy for prostate cancer for more than 2 months. Previous use of finasteride or dutasteride is allowed.
  • Prior invasive malignancy (except non-melanoma skin) unless disease-free for more than 5 years.
  • Prior radiotherapy to the pelvis
  • Life expectancy of less than 2 years.

Sites / Locations

  • McGill University Health Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMRT Hypofractionated

Arm Description

Neo-adjuvant hormone therapy for three months followed by IMRT combined with a 24-month hormonal therapy.

Outcomes

Primary Outcome Measures

Toxicity
Acute and late toxicity following treatment with IMRT to the prostate and pelvic lymphatic chains will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (http://ctep.cancer.gov) for grading of all adverse events will be used in this study.

Secondary Outcome Measures

Freedom from biochemical failure, patterns of failure.
To measure freedom from biochemical failure (PSA measurement) at 5 years.

Full Information

First Posted
August 22, 2012
Last Updated
September 26, 2016
Sponsor
Sergio Faria
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1. Study Identification

Unique Protocol Identification Number
NCT02107287
Brief Title
Hypofractionated Intensity Modulated Radiation Therapy Plus Hormonal Therapy in Patients With High Risk Prostate Cancer
Official Title
Hypofractionated Intensity Modulated Radiation Therapy Plus Hormonal Therapy in Patients With High Risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sergio Faria

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Considering the promising results with hypofractionated in low and intermediate risk prostate cancer, our proposal is to translate this experience to patients with high risk prostate cancer. Patients with high risk disease would receive hypofractionated RT to the prostate and to the external and internal iliac lymph nodes using IMRT plus long-term hormonal therapy. The objective of the study is to show that long term grade>2 late toxicity is acceptable and similar to published data using hypofractionated technique in the prostate only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Risk Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMRT Hypofractionated
Arm Type
Experimental
Arm Description
Neo-adjuvant hormone therapy for three months followed by IMRT combined with a 24-month hormonal therapy.
Intervention Type
Radiation
Intervention Name(s)
IMRT Technique
Primary Outcome Measure Information:
Title
Toxicity
Description
Acute and late toxicity following treatment with IMRT to the prostate and pelvic lymphatic chains will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (http://ctep.cancer.gov) for grading of all adverse events will be used in this study.
Time Frame
First 3 months (acute toxicity)
Secondary Outcome Measure Information:
Title
Freedom from biochemical failure, patterns of failure.
Description
To measure freedom from biochemical failure (PSA measurement) at 5 years.
Time Frame
At 5 years
Other Pre-specified Outcome Measures:
Title
Toxicity
Description
Late effects will be also scored prospectively using the RTOG/EORTC late scoring system. Erectile dysfunction will be assessed by the SHIM questionnaire
Time Frame
3 years
Title
Toxicity
Description
Dose-volume histogram of the rectum and bladder will be correlated to the whole organ volumes doses and the development of GI and GU toxicity.
Time Frame
3 years
Title
Rate of failure
Description
To determine the rate of local, regional and distant failures.
Time Frame
5 years
Title
Quality Assurance
Description
To develop a quality assurance process for IMRT in prostate cancer at McGill University Health Center
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pathologically proven diagnosis of adenocarcinoma of the prostate meeting one of the following conditions: Clinical Stage >T3 or Gleason Score 8 or higher, or PSA level >20ng/ml Study entry PSA must be obtained within 6 weeks prior to protocol entry ECOG <2 Age >18 History and physical examination within 3 months Bone scan and CT scan of the abdomen and pelvis within 3 months with no evidence of bone metastases and no pelvic lymph nodes larger than 1.0cm, unless biopsy negative. CBC with differential within 6 weeks prior to protocol entry Absolute neutrophil count >2000cells/mm3 Hemoglobin >8.0 g/dl (the use of transfusion to increase the Hg is acceptable) Testosterone level within 6 weeks of protocol entry Liver function tests Signed informed consent Prior use of hormonal therapy for prostate cancer is acceptable if less than 2 months. Exclusion Criteria: Prior use of hormonal therapy for prostate cancer for more than 2 months. Previous use of finasteride or dutasteride is allowed. Prior invasive malignancy (except non-melanoma skin) unless disease-free for more than 5 years. Prior radiotherapy to the pelvis Life expectancy of less than 2 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Faria, M.D.
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada

12. IPD Sharing Statement

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Hypofractionated Intensity Modulated Radiation Therapy Plus Hormonal Therapy in Patients With High Risk Prostate Cancer

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