A Phase 2/3 Randomized Trial of Whole Versus Partial Gland Boost During Prostate Stereotactic Body Radiotherapy (SBRT)
University of Nebraska
Summary
This phase 2/3 randomized trial evaluates whether dose escalation to the dominant intra-prostatic lesion (DIL) compared to whole gland dose escalation during prostate stereotactic body radiotherapy (SBRT) results in differences in genitourinary (GU) and gastrointestinal (GI) toxicities.
Description
This is a phase 2/3 randomized clinical trial evaluating two dose escalation strategies during prostate stereotactic body radiotherapy (SBRT). A total of 186 patients with prostate adenocarcinoma will be enrolled and randomized in a 1:1 ratio to one of two treatment arms. In both arms, patients will receive 3625 cGy delivered to the planning target volume (PTV) over 5 fractions. In Arm A, patients will receive a boost to the prostate gland. In Arm B, patients will receive a boost to the dominant intra-prostatic lesion (DIL) identified on pre-treatment magnetic resonance imaging (MRI). The pr…
Eligibility
- Age range
- 19+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults ≥19 years of age 2. Patients with a diagnosis of prostate adenocarcinoma for which stereotactic body radiotherapy (SBRT) to the prostate ± proximal seminal vesicles is being offered 3. Prostate gland volume \<100 cc prior to initiation of androgen deprivation therapy (ADT), as reported at time of biopsy or by imaging (e.g., ultrasound, MRI, or CT) 4. PI-RADS 4 or 5 lesion seen on pre-treatment MRI 5. IPSS/AUA symptom score less than 16 Exclusion Criteria: 1. Prior treatment for prostate cancer 2. Prior solid cancer diagnosis within the last 5 years 3. Any histo…
Interventions
- RadiationProstate stereotactic body radiotherapy with whole gland boost
External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost
- RadiationProstate stereotactic body radiotherapy with DIL boost
External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost to the dominant intra-prostatic lesion.
Location
- Fred & Pamela Buffet Cancer CenterOmaha, Nebraska