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

Not Applicable

Completed

• Conditions: High Risk Prostate Cancer
• Interventions: Radiation: IMRT Technique

• Registration Number: NCT02107287
• Lead Sponsor: Sergio Faria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-08
• Primary Completion: 2016-04
• Study Completion: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMRT Hypofractionated	IMRT Technique	Neo-adjuvant hormone therapy for three months followed by IMRT combined with a 24-month hormonal therapy.

Primary Outcome Measures

Name	Time	Method
Toxicity	First 3 months (acute 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

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

Trial Locations

Locations (1)

McGill University Health Center; 🇨🇦 Montreal, Quebec, Canada