Prostatic Neoplasms
Conditions
Keywords
Radiotherapy, Hypofractionation
Brief summary
The purpose of this study is to compare the toxicity of two new radiation schedules for the treatment of prostate cancer. Patients will be randomized to receive 5 treatments delivered every other day over 11 days, or once per week over 29 days. Both of these schedules are shorter than the standard treatment which is usually 39 treatments over 8 weeks.
Interventions
40 Gy / 5 fractions / 11 days
Sponsors
Study design
Eligibility
Inclusion criteria
* Low or intermediate risk prostate cancer patients as defined by: * Clinical stage T1-2b, Gleason Score \<=7, and PSA \<=20 ng/mL * Age \>= 18 years
Exclusion criteria
* Androgen deprivation therapy (LHRH-agonists or antiandrogens) \>6 months * Prior pelvic radiotherapy * Anticoagulation medication (if unsafe to discontinue for gold seed insertion) * Diagnosis of bleeding diathesis * Large prostate (\>90cm3) on imaging * Immunosuppressive medications * Inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bowel related quality-of-life | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal toxicity | During radiotherapy, at 3 and 6 months, then every 6 months after | Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema |
| Genitourinary toxicity | During radiotherapy, at 3 and 6 months, then every 6 months after | Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema |
| PSA relapse rate | 3 and 5 years | — |
| Patient Overall Quality of life | During radiotherapy, at 3 and 6 months, then every 6 months after | — |
| Salvage androgen deprivation therapy rate | 3 and 5 years | — |
Countries
Canada