Health Trials

Whole Versus Partial Gland Boost During Prostate SBRT

ConditionsProstate CancerProstate Adenocarcinoma
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 groups

Sponsors and collaborators

University of Nebraska

Lead sponsor

Source ClinicalTrials.gov