NCT04212715RecruitingPhase 2
Prostate SABR With Intra-Prostatic SABR Boost: A Phase II Study
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- King Saud University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Acute Toxicity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Experimental arm
Experimental
SABR 35Gy/5 to prostate, up to 50Gy/5 to MR nodule, and 25Gy/5 to pelvic nodes and SVs
Intervention: Pelvic SABR with intra-prostatic SABR (Radiation)
Outcomes
Primary Outcomes
Acute Toxicity
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Dr. Yasir Alayed
Consultant and Assistant Professor
King Saud University
Study Sites (1)
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