High Risk Prostate Cancer
Conditions
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.
Interventions
RADIATIONIMRT Technique
Sponsors
Sergio Faria
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Freedom from biochemical failure, patterns of failure. | At 5 years | To measure freedom from biochemical failure (PSA measurement) at 5 years. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Toxicity | 3 years | Late effects will be also scored prospectively using the RTOG/EORTC late scoring system. Erectile dysfunction will be assessed by the SHIM questionnaire |
| Rate of failure | 5 years | To determine the rate of local, regional and distant failures. |
| Quality Assurance | 5 years | To develop a quality assurance process for IMRT in prostate cancer at McGill University Health Center |
Countries
Canada
Outcome results
None listed