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

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.

Study Overview

• Status: Completed
• Conditions: High Risk Prostate Cancer
• Intervention / Treatment: Radiation: IMRT Technique

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • McGill University Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMRT Hypofractionated; Neo-adjuvant hormone therapy for three months followed by IMRT combined with a 24-month hormonal therapy.	Radiation: IMRT Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	First 3 months (acute toxicity)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from biochemical failure, patterns of failure.	To measure freedom from biochemical failure (PSA measurement) at 5 years.	At 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity	Late effects will be also scored prospectively using the RTOG/EORTC late scoring system. Erectile dysfunction will be assessed by the SHIM questionnaire	3 years
Toxicity	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.	3 years
Rate of failure	To determine the rate of local, regional and distant failures.	5 years
Quality Assurance	To develop a quality assurance process for IMRT in prostate cancer at McGill University Health Center	5 years

Collaborators and Investigators

• Sponsor: Sergio Faria
• Investigators: Principal Investigator: Sergio Faria, M.D., McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 22, 2012
• First Submitted That Met QC Criteria: April 4, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Estimate): September 27, 2016
• Last Update Submitted That Met QC Criteria: September 26, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 11-519 GEN