Whole Versus Partial Gland Boost During Prostate SBRT

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT07574489
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prostate stereotactic body radiotherapy with whole gland boost — RADIATION
    External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost
  • Prostate stereotactic body radiotherapy with DIL boost — RADIATION
    External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost to the dominant intra-prostatic lesion.

Study Details

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.

Key Dates

Start date
Jul 25, 2026
Status verified
Apr 2026
Primary completion
Aug 25, 2032
Completion
Aug 25, 2035

Study Design

Enrollment
186 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A: boost to prostate alone
    Participants assigned to Arm A will receive external beam radiation therapy consisting of 3625 cGy to the planning target volume (PTV), plus a boost of 4000 cGy to the clinical target volume (CTV), consisting of the prostate alone without a margin. Treatment will be delivered over 5 fractions with at least 36 hours between fractions via simultaneous integrated boost (SIB).
  • Experimental: Arm B: boost to dominant intra-prostatic lesion (DIL)
    Participants assigned to Arm B will receive external beam radiation therapy consisting of 3625 cGy to the planning target volume (PTV), plus a boost of 4500 cGy to the dominant intra-prostatic lesion (DIL). Treatment will be delivered over 5 fractions with at least 36 hours between fractions via simultaneous integrated boost (SIB).

Primary Outcome Measure

Grade 2 or Higher Chronic Genitourinary Toxicity [ Time Frame: From 6 months post-treatment to 2 years post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred & Pamela Buffet Cancer CenterOmahaNebraska68198
Michael Baine, MD, PhD
[email protected]
(402) 552-2703

Find similar trials in Omaha, NE

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Fred & Pamela Buffet Cancer Center· Omaha, NE

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