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

NCT ID: NCT02107287

Last Updated: 2016-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2016-06-30

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.

Conditions

High Risk Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IMRT Hypofractionated

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

Group Type: EXPERIMENTAL

IMRT Technique

Intervention Type: RADIATION

Interventions

IMRT Technique

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sergio Faria

OTHER

Sponsor Role: lead

Responsible Party

Sergio Faria

Associate Professor. Oncology.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sergio Faria, M.D.

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

McGill University Health Center

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

11-519 GEN

Identifier Type: -

Identifier Source: org_study_id