Not Yet RecruitingPhase 2/3

Whole Versus Partial Gland Boost During Prostate SBRT

United States186 participantsStarted 2026-07-25

Plain-language 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.

Who can participate

Age range19 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. IPSS/AUA symptom score less than 16

Exclusion criteria

✕. 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
✕. History of prior circumferential resection of the rectum (such as LAR or APR)

What they're measuring

Grade 2 or Higher Chronic Genitourinary Toxicity

Timeframe: From 6 months post-treatment to 2 years post-treatment

Grade 2 or Higher Chronic Gastrointestinal Toxicity

Timeframe: From 6 months post-treatment to 2 years post-treatment

Trial details

NCT IDNCT07574489

SponsorUniversity of Nebraska

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2032-08-25

Contact for this trial

Krishna Gottipati, MS

4025593518 krgottipati@unmc.edu

View on ClinicalTrials.gov More Prostate Cancer trials