Prostate Cancer
Conditions
Brief summary
Stereotactic Ablative Radiation(SABR) 35 Gy in 5 fractions, once weekly to prostate with simultaneous intraprostatic boost to the MR detected nodule up to 50Gy + 25 Gy in 5 fractions, once weekly simultaneously to seminal vesicles (SV's) and pelvic lymph nodes + 6-18 months of ADT
Detailed description
SABR 25Gy / 5 fractions to pelvis; 35Gy / 5 fractions to prostate; up to 50Gy / 5 fractions to MR nodule
Interventions
described elsewhere
Sponsors
Andrew Loblaw
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed prostate adenocarcinoma (centrally reviewed) * High- tier intermediate risk defined as: PSA 10-20ng/ml AND (T2b-2c OR Gleason 7 ) • High-risk prostate cancer, defined as at least one of: T3, OR Gleason 8-10, OR PSA \> 20 ng/mL * Willing to give informed consent to participate in this clinical trial * Able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire
Exclusion criteria
* Prior pelvic radiotherapy * Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease * Contraindication to prostate MRI * Anticoagulation medication (if unsafe to discontinue for gold seed insertion) * Diagnosis of bleeding diathesis * Large prostate with significant arch interference on TRUS after 3 months of neoadjuvant ADT. * Previous TURP * Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>20 * Significant medical co-morbidity rendering patient unsuitable for general anesthetic * No 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To document the number of patients with grade 3 or higher acute urinary and/or bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria | 3 months after accrual target is reached |
Outcome results
None listed