Hypofractionated Intensity Modulated Radiation Therapy Plus Hormonal Therapy in Patients With High Risk Prostate Cancer
Conditions
High Risk Prostate Cancer
Conditions: official terms
Prostatic Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: IMRT Technique
Type: Radiation
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Male
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.
Location
McGill University Health Center
Montreal, Quebec, Canada
Status: Recruiting
Contact: Sergio Faria, M.D, Ph.D - 514-934-8040 - sergio.faria@muhc.mcgill.ca
Start Date
August 2011
Completion Date
June 2016
Sponsors
Sergio Faria
Source
McGill University Health Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page