5 Fractions of Pelvic SABR With Intra Prostatic SABR
Not Applicable
- Conditions
- Prostate Cancer
- Interventions
- Radiation: Pelvic SABR with intra-prostatic SABR
- Registration Number
- NCT02911636
- Lead Sponsor
- Andrew Loblaw
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Pelvic SABR with intra-prostatic SABR Pelvic SABR with intra-prostatic SABR
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method