Whole Versus Partial Gland Boost During Prostate SBRT
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexMale
Age19+
SponsorUniversity of Nebraska
About this trial
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.
Eligibility criteria
Qualifiers
Adults ≥19 years of age
Patients with a diagnosis of prostate adenocarcinoma for which stereotactic body radiotherapy (SBRT) to the prostate ± proximal seminal vesicles is being offered
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)
PI-RADS 4 or 5 lesion seen on pre-treatment MRI
Disqualifiers
Prior treatment for prostate cancer
Prior solid cancer diagnosis within the last 5 years
Any history of anal or rectal cancer
Any history of invasive carcinoma of the bladder
Trial design
Treatments tested in this trial
- Prostate stereotactic body radiotherapy with whole gland boost
- Prostate stereotactic body radiotherapy with DIL boost
Treatment groups
186 Participants
are divided into 2 treatment groupsLocations
1Fred & Pamela Buffet Cancer Center68198, OmahaNebraska, United States
Sponsors and collaborators
University of Nebraska
Lead sponsor
Source ClinicalTrials.gov