Prostate CancerPhase 2NCT07574489
Whole Versus Partial Gland Boost During Prostate SBRT
A Phase 2 study testing Prostate stereotactic body radiotherapy with whole gland boost and Prostate stereotactic body radiotherapy with DIL boost in people with Prostate Cancer and Prostate Adenocarcinoma, run by University of Nebraska at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma
- What is being tested?
- Prostate stereotactic body radiotherapy with whole gland boost and Prostate stereotactic body radiotherapy with DIL boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Dec 2026to 25 Dec 2035
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Prior treatment for prostate cancer
- Prior solid cancer diagnosis in 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)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Fred & Pamela Buffet Cancer Center
Omaha, Nebraska, 68198
Michael Baine, MD, PhD, (402) 552-2703, mbaine@unmc.edu
About this study
Official title: Whole Versus Partial Gland Boost During Prostate SBRT (Gland Boost)
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.
Read the detailed description
This is a phase 2 randomized clinical trial evaluating two dose escalation strategies during prostate stereotactic body radiotherapy (SBRT). A total of 160 patients with prostate adenocarcinoma will be enrolled and randomized in a 1:1 ratio to one of two treatment arms.
160 patients will be enrolled in this study over 3.2 years. Eligible participants will be stratified by risk group and tamsulosin use and randomized to one of two treatment arms. Both arms will receive 3625 cGy to the prostate plus planning margin delivered over 5 fractions. Arm A will receive an additional boost of 4000 cGy to the prostate alone. Arm B will receive an additional boost of 4500 cGy to the dominant intra-prostatic lesion (DIL). Acute and chronic GU and GI toxicities will be measured, as well as biochemical progression-free survival. Toxicities will be measured using CTCAE, Radiation Therapy Oncology Group, and Expanded Prostate Cancer Index Composite domains.
Participants will be followed for up to 5 years after completion of treatment.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Being tested
- Prostate stereotactic body radiotherapy with whole gland boost, Prostate stereotactic body radiotherapy with DIL boost
- Keywords
- Prostate SBRT, Stereotactic Body Radiotherapy, Dose Escalation, Dominant Intraprostatic Lesion, DIL, Radiation Therapy, Genitourinary Toxicity, Gastrointestinal Toxicity, CTCAE, RTOG, EPIC
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate stereotactic body radiotherapy with whole gland boostRadiation
External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost
Prostate stereotactic body radiotherapy with DIL boostRadiation
External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost to the dominant intra-prostatic lesion.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: boost to prostate alone | 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). Receives: Radiation: Prostate stereotactic body radiotherapy with whole gland boost |
| Arm B: boost to dominant intra-prostatic lesion (DIL) | 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). Receives: Radiation: Prostate stereotactic body radiotherapy with DIL boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 2 or Higher Acute Genitourinary Toxicity
To evaluate acute genitourinary (GU) toxicities grade 2 or higher by cumulative incidence from the end of treatment to 3 months post-treatment using Common Terminology Criteria for Adverse Events Version 6.0 (CTCAE)
Measured: From end of treatment to 3 months post-treatment
Secondary outcomes (6)
Grade 2 or Higher Acute Gastrointestinal Toxicity
To evaluate gastrointestinal (GI) toxicities grade 2 or higher by cumulative incidence from the end of treatment to 3 months post-treatment using CTCAE
Measured: From end of treatment to 3 months post-treatment
Biochemical Progression-Free Survival
Time from initiation of study treatment to biochemical disease progression or death from any cause
Measured: From initiation of study treatment to 5 years post-treatment
Chronic Gastrointestinal Toxicity - Cumulative Incidence
Cumulative incidence of chronic gastrointestinal (GI) toxicities assessed using CTCAE, Radiation Therapy Oncology Group (RTOG), and Expanded Prostate Cancer Index Composite (EPIC) domains.
Measured: From 6 months to 21 months post-treatment
Chronic Genitourinary Toxicity - Cumulative Incidence
Cumulative incidence of chronic genitourinary (GU) toxicities assessed using CTCAE, RTOG, and EPIC domains.
Measured: From 6 months to 21 months post-treatment
Chronic Gastrointestinal Toxicity
To evaluate chronic GI toxicities at 5 years using CTCAE, RTOG, and EPIC domains.
Measured: At 5 years
Chronic Genitourinary Toxicity
To evaluate chronic GU toxicities at 5 years using CTCAE, RTOG, and EPIC domains.
Measured: At 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start25 Dec 2026 (estimated)
- Primary completion25 Dec 2032 (estimated)
- Study completion25 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Baine, MD, PhD, Principal investigator, University of Nebraska medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574489
- Sponsor's protocol ID
- Gland Boost
- Status last verified
- Oct 2026
- First submitted
- 30 Apr 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Versus Partial Gland Boost During Prostate SBRT (Gland Boost)
- ClinicalTrials.gov ID
- NCT07574489
- Acronym / sponsor ID
- Gland Boost
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Keywords
- Prostate SBRT, Stereotactic Body Radiotherapy, Dose Escalation, Dominant Intraprostatic Lesion, DIL, Radiation Therapy, Genitourinary Toxicity, Gastrointestinal Toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 25 Dec 2026 (estimated)
- Primary completion
- 25 Dec 2032 (estimated)
- Study completion
- 25 Dec 2035 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase 2 randomized clinical trial evaluating two dose escalation strategies during prostate stereotactic body radiotherapy (SBRT). A total of 160 patients with prostate adenocarcinoma will be enrolled and randomized in a 1:1 ratio to one of two treatment arms.
160 patients will be enrolled in this study over 3.2 years. Eligible participants will be stratified by risk group and tamsulosin use and randomized to one of two treatment arms. Both arms will receive 3625 cGy to the prostate plus planning margin delivered over 5 fractions. Arm A will receive an additional boost of 4000 cGy to the prostate alone. Arm B will receive an additional boost of 4500 cGy to the dominant intra-prostatic lesion (DIL). Acute and chronic GU and GI toxicities will be measured, as well as biochemical progression-free survival. Toxicities will be measured using CTCAE, Radiation Therapy Oncology Group, and Expanded Prostate Cancer Index Composite domains.
Participants will be followed for up to 5 years after completion of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: boost to prostate alone | Active comparator | Radiation: Prostate stereotactic body radiotherapy with whole gland boostParticipants 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). |
| Arm B: boost to dominant intra-prostatic lesion (DIL) | Experimental | Radiation: Prostate stereotactic body radiotherapy with DIL boostParticipants 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). |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Prior treatment for prostate cancer
- Prior solid cancer diagnosis in 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate stereotactic body radiotherapy with whole gland boostExternal beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost | Radiation | Arm A: boost to prostate alone |
| Prostate stereotactic body radiotherapy with DIL boostExternal beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost to the dominant intra-prostatic lesion. | Radiation | Arm B: boost to dominant intra-prostatic lesion (DIL) |
Primary outcome
Grade 2 or Higher Acute Genitourinary Toxicity
Time frame: From end of treatment to 3 months post-treatment
To evaluate acute genitourinary (GU) toxicities grade 2 or higher by cumulative incidence from the end of treatment to 3 months post-treatment using Common Terminology Criteria for Adverse Events Version 6.0 (CTCAE)
6 secondary outcomes
Grade 2 or Higher Acute Gastrointestinal Toxicity
Time frame: From end of treatment to 3 months post-treatment
Biochemical Progression-Free Survival
Time frame: From initiation of study treatment to 5 years post-treatment
Chronic Gastrointestinal Toxicity - Cumulative Incidence
Time frame: From 6 months to 21 months post-treatment
Chronic Genitourinary Toxicity - Cumulative Incidence
Time frame: From 6 months to 21 months post-treatment
Chronic Gastrointestinal Toxicity
Time frame: At 5 years
Chronic Genitourinary Toxicity
Time frame: At 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Baine, MD, PhD principal investigator
University of Nebraska medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prostate stereotactic body radiotherapy with whole gland boost and Prostate stereotactic body radiotherapy with DIL boost in people with Prostate Cancer and Prostate Adenocarcinoma, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krishna Gottipati, MS (4025593518, krgottipati@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 2 or Higher Acute Genitourinary Toxicity (time frame: From end of treatment to 3 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.