Prostate SABR With Intra-Prostatic SABR Boost
Phase 2
Recruiting
- Conditions
- Prostate Cancer
- Interventions
- Radiation: Pelvic SABR with intra-prostatic SABR
- Registration Number
- NCT04212715
- Lead Sponsor
- King Saud University
- Brief Summary
Stereotactic Ablative Radiation (SABR/SBRT) will be prescribed to a dose of 35 Gy in 5 fractions, once weekly to prostate with a simultaneous intra-prostatic boost to the MR detected nodule up to 50Gy. The pelvic lymph nodes and seminal vesicles will also receive 25 Gy in 5 weekly fractions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 30
Inclusion Criteria
- Histologically confirmed prostate adenocarcinoma
- 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
Exclusion Criteria
- Prior pelvic radiotherapy
- Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
- Contraindication to prostate MRI
- 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 Experimental arm Pelvic SABR with intra-prostatic SABR SABR 35Gy/5 to prostate, up to 50Gy/5 to MR nodule, and 25Gy/5 to pelvic nodes and SVs
- Primary Outcome Measures
Name Time Method Acute Toxicity 3 month after accrual is completed To document the rate of acute urinary and bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) criteria
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
King Saud University Medical City
🇸🇦Riyadh, Saudi Arabia