Whole Versus Partial Gland Boost During Prostate SBRT

NCT07574489 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Gland Boost
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Keywords

Prostate SBRT; Stereotactic Body Radiotherapy; Dose Escalation; Dominant Intraprostatic Lesion; DIL; Radiation Therapy; Genitourinary Toxicity; Gastrointestinal Toxicity; CTCAE; RTOG; EPIC

Outcome Measures

Primary Outcomes (2)

• Grade 2 or Higher Chronic Genitourinary Toxicity

  Cumulative incidence of grade 2 or higher chronic genitourinary (GU) toxicities assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

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

• Grade 2 or Higher Chronic Gastrointestinal Toxicity

  Cumulative incidence of grade 2 or higher chronic genitourinary (GI) toxicities assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

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

Secondary Outcomes (5)

• Biochemical Progression-Free Survival

  From initiation of study treatment to 5 years post-treatment

• Acute Gastrointestinal Toxicity

  From end of treatment to 6 months post-treatment

• Acute Genitourinary Toxicity

  From end of treatment to 6 months post-treatment

• Chronic Gastrointestinal Toxicity

  From 6 months post-treatment to 5 years post-treatment

• Chronic Genitourinary Toxicity

  From 6 months post-treatment to 5 years post-treatment

Study Arms (2)

Arm A

ACTIVE COMPARATOR

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).

Radiation: Prostate stereotactic body radiotherapy with whole gland boost

Arm B

EXPERIMENTAL

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).

Radiation: Prostate stereotactic body radiotherapy with DIL boost

Interventions

Prostate stereotactic body radiotherapy with whole gland boost RADIATION

External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost

Arm A

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.

Arm B

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: This study includes only male participants because it is limited to patients with prostate adenocarcinoma
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Fred & Pamela Buffet Cancer Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Michael Baine, MD, PhD

  University of Nebraska medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krishna Gottipati, MS

CONTACT

4025593518; krgottipati@unmc.edu

IIT Office Gottipati

CONTACT

4025590963; IITOFFICE@unmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): July 25, 2026
• Primary Completion (Estimated): August 25, 2032
• Study Completion (Estimated): August 25, 2035
• Last Updated: May 8, 2026

Record last verified: 2026-04

Locations

US (1)