Prostate Cancer
Conditions
Brief summary
Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT. 5-fraction SABR is a feasible, well-tolerated, effective and cost effective treatment for high-intermediate and high risk prostate cancer with/without an image-guided intraprostatic boost.
Interventions
RADIATIONStereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5
Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.
Sponsors
Prostate Cure Foundation
Sunnybrook Health Sciences Centre
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
* Histologically confirmed prostate adenocarcinoma (centrally reviewed) * High-intermediate risk defined as two or more of: T2c, Gleason 7 OR PSA 10-20ng/ml, * High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA \> 20 ng/mL * Willing to give informed consent to participate in this clinical trial * Able and willing to complete EPIC, PORPUS and EQ-5D questionnaires
Exclusion criteria
* Prior pelvic radiotherapy * Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease * Anticoagulation medication (if unsafe to discontinue for fiducial insertion) * Diagnosis of bleeding diathesis * Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>20 * Evidence of castrate resistance (defined as PSA \< 3 ng/ml while testosterone is \< 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression. * Definitive extrapelvic nodal or distant metastatic disease on staging investigations. * Hip prosthesis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Toxicity | Baseline to 3 months post completion of treatment | To document the acute urinary toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life outcome | Baseline to end of 5 year follow up | Measuring quality of life using Expanded Prostate Index Composite (EPIC) |
| Biochemical disease-free survival | Baseline to end of 5 year follow up | Biochemical disease-free survival |
| Quality of life outcome | Baseline to end of 5 year follow up | Health utilities using the EQ-5D Quality of Life Questionnaire tool |
| Economic analysis | Baseline to end of 5 year follow up | Cost effectiveness of treatment.Quality of life and cost estimates will be captured for each patient from time of the initiation of treatment until death. The effectiveness endpoints will be biochemical disease free survival and quality-adjusted life years (QALYs). QALY will be calculated by survival (in years) multiplied by a utility weight associated with a certain condition. |
Countries
Canada
Outcome results
None listed