Prostate CancerNCT05628363
Adaptive Stereotactic Body Radiation Therapy to the Prostate and Pelvic Nodes With Simultaneous Integrated Boost to the MR-detected Nodule for Patients With High-risk and Unfavorable Intermediate-risk Prostate Cancer
A study testing Ethos Varian treatment system, Adaptive stereotactic body radiotherapy and Androgen deprivation therapy in people with Prostate Cancer and Cancer of the Prostate, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This trial is a prospective clinical trial designed to demonstrate the safety and feasibility of whole-pelvis adaptive prostate stereotactic body radiation therapy (SBRT) with a tumor boost to the magnetic resonance (MR)-detected sites of disease. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Cancer of the Prostate
- What is being tested?
- Ethos Varian treatment system, Adaptive stereotactic body radiotherapy and Androgen deprivation therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2023to 25 Jul 2030
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven adenocarcinoma of the prostate with NCCN high-risk disease or NCCN unfavorable intermediate-risk disease.
- Patients with unfavorable intermediate-risk disease must meet the following criteria:
- At least one intermediate risk factor (IRF):
- PSA 10-20 ng/mL
- cT2b-c (AJCC 8th ed.)
- Gleason score 7
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- At least one "unfavorable" intermediate-risk identifier:
- > 1 IRF
- Gleason score 4+3
- ≥ 50% of biopsy cores positive
- NO high-risk features
- Patients with high-risk disease must meet at least one of the following criteria:
- cT3a-T3b
- PSA > 20
- Gleason score ≥ 8
- MRI scan of the prostate with at least one MR-detectable lesion in the prostate/seminal vesicles. PET/CT which is found to display activity n the prostate consistent with prostate cancer may be substituted per investigator discretion.
- Planning to undergo concurrent whole-pelvis SBRT and androgen deprivation therapy (ADT). ADT may be initiated at any time per institutional standard, so long as ADT begins within 60 days of the start of radiotherapy.
- At least 18 years of age.
- ECOG performance status ≤ 1
- Agreement to adhere to Lifestyle Considerations throughout study duration
- Able to complete relevant patient-reported quality-of-life questionnaires in the opinion of the treating physician.
- Able to understand and willing to sign an IRB approved written informed consent document.
Who cannot join
- Definitive radiologic evidence of nodal (cN+) or metastatic (cM1) disease on conventional imaging (bone scan) or prostate cancer-specific PET/CT scan (NaF PET/CT, Axumin PET/CT, fluciclovine, choline, or PSMA PET/CT scan). Patients with lymph nodes ≥ 1 cm on short axis are ineligible unless the lymph node is read as benign by Radiology.
- Prior androgen deprivation therapy. (If the onset of androgen ablation is ≤ 60 days prior to treatment start, the patient is eligible.) Baseline PSA and testosterone must be obtained prior to start of treatment.
- Systemic chemotherapy within 3 years prior to treatment start.
- Prior radical prostatectomy, pelvic lymph node dissection, prostate cryotherapy, or high-intensity focused ultrasound (HIFU) to the prostate.
- Prior pelvic radiotherapy.
- Presence of baseline CTCAE grade ≥ 2 GI or GU toxicity that does not resolve to grade 1 or less with appropriate intervention.
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- cT4 disease.
- American Urologic Association (AUA) urinary symptom score ≥ 20
- Prostate gland measuring >90 cc.
- Unable to get prostate fiducial markers placed for image guided radiation treatment. Rectal hydrogel is optional and is left to the discretion of the treating physician.
- Hip prosthetic that does not allow for treatment planning visualization.
- Prior malignancy (except for non-melanoma skin cancer) unless disease-free for at least 2 years. Patients are not eligible if they have had a prior pelvic malignancy (e.g. bladder cancer, rectal cancer).
- Prior transurethral resection of the prostate (TURP) within 3 months prior to registration.
- Uncontrolled intercurrent illness precluding RT and/or ADT including, but not limited to, seizures, myocardial infarction in the past 6 months, current severe or unstable angina pectoris, congestive heart failure requiring hospitalization in the past 6 months, uncontrolled active infection, uncontrolled hypertension, or any condition that in the opinion of the investigator would preclude participation in the study.
- History of uncontrolled inflammatory bowel disease, including ulcerative colitis and Crohn's disease.
- Presence of anal fissure or history of bowel or bladder fistula.
- Scleroderma. Patients who are moderately symptomatic from other autoimmune diseases or patients on biologic therapies for autoimmune diseases are also excluded.
- Known history of HIV or chronic hepatitis B or C. Testing to evaluate for the presence of HIV and/or hepatitis B or C is not required in patients who do not carry the diagnosis.
- Poorly visualized bladder and bowel on diagnostic CT or CT simulation (either due to body habitus or artifact).
- Unable to spend 30 minutes lying on the radiation therapy treatment couch due to significant urinary frequency/urgency or other comorbidities.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
This trial is a prospective clinical trial designed to demonstrate the safety and feasibility of whole-pelvis adaptive prostate stereotactic body radiation therapy (SBRT) with a tumor boost to the magnetic resonance (MR)-detected sites of disease. The hypothesis is that this treatment approach will be safe and feasible with <15% of patients experiencing an acute CTCAEv5 grade ≥3 genitourinary (GU) or gastrointestinal (GI) adverse event.
- Conditions
- Prostate Cancer, Cancer of the Prostate
- Being tested
- Ethos Varian treatment system, Adaptive stereotactic body radiotherapy, Androgen deprivation therapy
- Keywords
- Prostate cancer, stereotactic body radiation therapy, SBRT, whole pelvis prostate SBRT, adaptive radiation, tumor-directed boost
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethos Varian treatment systemDevice
Device that will be used to administer radiotherapy
Adaptive stereotactic body radiotherapyRadiation
Also called SBRT
Radiotherapy interruptions are acceptable as long as treatments are no more than 16 days apart.
Androgen deprivation therapyDrug
Also called ADT
Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Patients should initiate ADT beginning no sooner than 60 days prior to start of radiation. ADT is defined as a GnRH agonist/antagonist (leuprolide, goserelin, degarelix, or relugolix). Patients treated with leuprolide, goserelin, or degarelix should also receive an androgen receptor antagonist (flutamide or bicalutamide) for 30 days from the start of GnRH agonist/antagonist or until the end of radiation, depending on institutional standard and physician preference.
Agent selection is per treating physician discretion and will be administered per institutional standard and FDA-approved labeling.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive stereotactic body radiotherapy (SBRT) | Experimental | * Treatment consists of adaptive dose-escalated stereotactic body radiotherapy (SBRT) to the pelvic nodes to 25 Gy in 5 once or twice weekly fractions with simultaneous integrated boosts (SIB) to the prostate and proximal seminal vesicles to 36.25 Gy in 5 fractions (full seminal vesicles if involved), to the prostate to 40 Gy in 5 fractions, and to the involved MR-detected nodule(s) to up to 50 Gy in 5 fractions.
* Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Unfavorable Intermediate-risk Disease: Patients should receive a minimum of 4 months of ADT. Patients can receive longer duration of ADT at the discretion of the treating physician. High-risk disease: Patients should receive a minimum of 1 year of ADT. Patients can receive up to 2 years of ADT at the discretion of the treating physician. Receives: Device: Ethos Varian treatment system; Radiation: Adaptive stereotactic body radiotherapy; Drug: Androgen deprivation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Acute Grade ≥3 GI and GU Adverse Events
Measured: From start of radiotherapy through 90 days after start of radiotherapy
Secondary outcomes (4)
Changes in Patient-reported Quality of Life as Measured by EPIC-26
-The EPIC-26 is used to assess health related quality of life among persons with prostate cancer. It contains 5 domains of urinary incontinence, urinary irritability/obstructive, bowel, sexual, and hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life.
Measured: At screening, end of radiotherapy (week 5), 3 months after start of radiotherapy, and every 3 months until month 24
Changes in Global Function as Measured by EQ-5D-5L
-The EQ-5D-5L is a commonly used and reliable questionnaire used to assess patient perception of their current health state. Patients are asked about their levels of difficulty with mobility, self-care, and usual activities, and about their pain/discomfort and anxiety/depression levels on a 5-point scale where the response "I have no problems" = 1 and "I am unable/have extreme" = 5.
Measured: At screening, end of radiotherapy (week 5), 3 months after start of radiotherapy, and every 3 months until month 24
Number of Participants With Acute Grade ≥3 Adverse Events at Least Possibly Related to Radiotherapy
Measured: From start of radiotherapy through 90 days after start of radiotherapy
Number of Participants With Acute <Grade 3 GI and GU Adverse Events
Measured: From start of radiotherapy through 90 days after start of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start18 Jan 2023
- Primary completion25 Oct 2025
- Study completion25 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Sponsor
- Investigators
- Amit Bhatt, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628363
- Sponsor's protocol ID
- 202211121
- Status last verified
- Jun 2026
- First submitted
- 16 Nov 2022
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Stereotactic Body Radiation Therapy to the Prostate and Pelvic Nodes With Simultaneous Integrated Boost to the MR-detected Nodule for Patients With High-risk and Unfavorable Intermediate-risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT05628363
- Acronym / sponsor ID
- 202211121
- Conditions
- Prostate Cancer, Cancer of the Prostate
- Keywords
- Prostate cancer, stereotactic body radiation therapy, SBRT, whole pelvis prostate SBRT, adaptive radiation, tumor-directed boost
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 25 Oct 2025 (actual)
- Study completion
- 25 Jul 2030 (estimated)
- First posted
- 28 Nov 2022 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a prospective clinical trial designed to demonstrate the safety and feasibility of whole-pelvis adaptive prostate stereotactic body radiation therapy (SBRT) with a tumor boost to the magnetic resonance (MR)-detected sites of disease. The hypothesis is that this treatment approach will be safe and feasible with <15% of patients experiencing an acute CTCAEv5 grade ≥3 genitourinary (GU) or gastrointestinal (GI) adverse event.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptive stereotactic body radiotherapy (SBRT) | Experimental | Device: Ethos Varian treatment system, Radiation: Adaptive stereotactic body radiotherapy, Drug: Androgen deprivation therapy* Treatment consists of adaptive dose-escalated stereotactic body radiotherapy (SBRT) to the pelvic nodes to 25 Gy in 5 once or twice weekly fractions with simultaneous integrated boosts (SIB) to the prostate and proximal seminal vesicles to 36.25 Gy in 5 fractions (full seminal vesicles if involved), to the prostate to 40 Gy in 5 fractions, and to the involved MR-detected nodule(s) to up to 50 Gy in 5 fractions. * Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Unfavorable Intermediate-risk Disease: Patients should receive a minimum of 4 months of ADT. Patients can receive longer duration of ADT at the discretion of the treating physician. High-risk disease: Patients should receive a minimum of 1 year of ADT. Patients can receive up to 2 years of ADT at the discretion of the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Pathologically proven adenocarcinoma of the prostate with NCCN high-risk disease or NCCN unfavorable intermediate-risk disease.
- Patients with unfavorable intermediate-risk disease must meet the following criteria:
- Patients with high-risk disease must meet at least one of the following criteria:
- MRI scan of the prostate with at least one MR-detectable lesion in the prostate/seminal vesicles. PET/CT which is found to display activity n the prostate consistent with prostate cancer may be substituted per investigator discretion.
- Planning to undergo concurrent whole-pelvis SBRT and androgen deprivation therapy (ADT). ADT may be initiated at any time per institutional standard, so long as ADT begins within 60 days of the start of radiotherapy.
Key exclusion criteria (20 listed)
- Definitive radiologic evidence of nodal (cN+) or metastatic (cM1) disease on conventional imaging (bone scan) or prostate cancer-specific PET/CT scan (NaF PET/CT, Axumin PET/CT, fluciclovine, choline, or PSMA PET/CT scan). Patients with lymph nodes ≥ 1 cm on short axis are ineligible unless the lymph node is read as benign by Radiology.
- Prior androgen deprivation therapy. (If the onset of androgen ablation is ≤ 60 days prior to treatment start, the patient is eligible.) Baseline PSA and testosterone must be obtained prior to start of treatment.
- Systemic chemotherapy within 3 years prior to treatment start.
- Prior radical prostatectomy, pelvic lymph node dissection, prostate cryotherapy, or high-intensity focused ultrasound (HIFU) to the prostate.
- Prior pelvic radiotherapy.
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 |
|---|---|---|
| Ethos Varian treatment systemDevice that will be used to administer radiotherapy | Device | Adaptive stereotactic body radiotherapy (SBRT) |
| Adaptive stereotactic body radiotherapyAlso: SBRTRadiotherapy interruptions are acceptable as long as treatments are no more than 16 days apart. | Radiation | Adaptive stereotactic body radiotherapy (SBRT) |
| Androgen deprivation therapyAlso: ADTAndrogen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Patients should initiate ADT beginning no sooner than 60 days prior to start of radiation. ADT is defined as a GnRH agonist/antagonist (leuprolide, goserelin, degarelix, or relugolix). Patients treated with leuprolide, goserelin, or degarelix should also receive an androgen receptor antagonist (flutamide or bicalutamide) for 30 days from the start of GnRH agonist/antagonist or until the end of radiation, depending on institutional standard and physician preference. Agent selection is per treating physician discretion and will be administered per institutional standard and FDA-approved labeling. | Drug | Adaptive stereotactic body radiotherapy (SBRT) |
Primary outcome
Number of Participants With Acute Grade ≥3 GI and GU Adverse Events
Time frame: From start of radiotherapy through 90 days after start of radiotherapy
4 secondary outcomes
Changes in Patient-reported Quality of Life as Measured by EPIC-26
Time frame: At screening, end of radiotherapy (week 5), 3 months after start of radiotherapy, and every 3 months until month 24
Changes in Global Function as Measured by EQ-5D-5L
Time frame: At screening, end of radiotherapy (week 5), 3 months after start of radiotherapy, and every 3 months until month 24
Number of Participants With Acute Grade ≥3 Adverse Events at Least Possibly Related to Radiotherapy
Time frame: From start of radiotherapy through 90 days after start of radiotherapy
Number of Participants With Acute <Grade 3 GI and GU Adverse Events
Time frame: From start of radiotherapy through 90 days after start of radiotherapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Amit Bhatt, M.D., Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethos Varian treatment system, Adaptive stereotactic body radiotherapy and Androgen deprivation therapy in people with Prostate Cancer and Cancer of the Prostate, run by Washington University School of Medicine 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 22 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Acute Grade ≥3 GI and GU Adverse Events (time frame: From start of radiotherapy through 90 days after start of radiotherapy). 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 2 Jul 2026.