Early access
Sign in
Not yet taking people in United StatesPhase 2

Comparing Radiation Boosts to the Whole Prostate or Main Tumor Area in Prostate Cancer

Compares extra radiation to the whole prostate versus the main tumor spot.

Key facts

Who runs it
University of Nebraska
Where
Omaha, United StatesSee the site
Trial code
Registry title
Whole Versus Partial Gland Boost During Prostate SBRT
Status
Not yet recruiting
Phase
Phase 2
People taking part
160 people, planned
Starts
25 Dec 2026
Expected to end
25 Dec 2035
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Prostate stereotactic body radiotherapy with whole gland boost
  • Prostate stereotactic body radiotherapy with DIL boost
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult men with prostate adenocarcinoma who are being offered stereotactic body radiotherapy (SBRT). It compares a higher radiation dose to the whole prostate with a higher dose to the main tumour area.

Age
19 years or older
Sex
Men only
Disease stage
Prostate adenocarcinoma with a PI-RADS 4 or 5 lesion seen on MRI before treatment. Prostate volume less than 100 cc before starting ADT. IPSS/AUA symptom score less than 16.
Earlier treatment
No earlier treatment for prostate cancer.

Main reasons for not taking part

  • Prior treatment for prostate cancer
  • Another solid cancer diagnosed in the last 5 years
  • Any history of anal or rectal cancer
  • Any history of invasive bladder cancer
  • Prior circumferential resection of the rectum (such as LAR or APR)

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • Adults ≥19 years of age
  • Patients with a diagnosis of prostate adenocarcinoma for whom SBRT to the prostate +/- proximal seminal vesicles is being offered
  • Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities, including MRI or CT scan
  • PI-RADS 4 or 5 lesion seen on pretreatment MRI
  • IPSS/AUA (Appendix D, E) symptom score less than 16

Who cannot take part

  • Prior treatment for prostate cancer
  • Prior solid cancer diagnosis in the last 5 years
  • History of prior circumferential resection of the rectum (such as LAR or APR)
  • Any history of anal or rectal cancer
  • Any history of invasive carcinoma of the bladder
  • History of inflammatory bowel syndromes not adequately controlled on current medication regimen
  • Urinary or fecal incontinence or chronic diarrhea requiring more than 1 pad per day

Where in United States

  • Fred & Pamela Buffet Cancer CenterOmaha, United StatesContact: Michael Baine, MD, PhDNot yet recruiting

About the trial

What the trial wants to find out

The purpose of this randomized phase II trial is to compare dose escalation of the prostate versus the dominant intra-prostatic lesion in a reduced fraction radiation therapy regimen.

The 2 groups in the trial

  • Arm A: boost to prostate aloneExisting treatment, for comparison

    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).

    Treatment: Prostate stereotactic body radiotherapy with whole gland boost

  • Arm B: boost to dominant intra-prostatic lesion (DIL)Treatment being tested

    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).

    Treatment: Prostate stereotactic body radiotherapy with DIL boost

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Whole Versus Partial Gland Boost During Prostate SBRT (Gland Boost)
Plain-language title
Comparing Radiation Boosts to the Whole Prostate or Main Tumor Area in Prostate CancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
3 November 2026