Prostate CancerARTIA-ProstateNCT05804318
Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer
A study testing Daily adaptive SBRT with urethral sparing in people with Prostate Cancer, run by Varian, a Siemens Healthineers Company at 8 sites in 3 countries.
Trial summary
This trial is a prospective, single-arm, multi-center clinical trial designed to assess whether adaptive radiotherapy with urethral sparing for low to intermediate risk localized prostate cancer will translate into a decreased rate of patient reported acute urinary side effects, as measured by the patient reported… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Daily adaptive SBRT with urethral sparing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 13 Apr 2023to Oct 2031
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has NCCN low or intermediate risk prostate cancer that is biopsy proven.
- Prostate volume is ≤80cc as assessed by MRI prior to radiotherapy.
- AUA/IPSS score is ≤ 15.
- ECOG performance status is ≤2 (or Karnofsky score is ≥60%).
- Patient has no PIRADS 4 or 5 lesion on prostate MRI contacting the urethra (determined at physician discretion).
- Patient has the ability to complete required patient questionnaires.
- Patient age ≥ 18 years (or greater than the local age of majority).
- Patient has the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patient has baseline grade ≥3 GI or GU toxicity
- Patient has had prior overlapping pelvic radiotherapy.
- Patient has had prior transurethral resection of the prostate, prostate HIFU, or cryoablation.
- Patient has node positive prostate cancer.
- Patient has extracapsular extension (capsular abutment is permitted).
- Patient has active inflammatory bowel disease or active collagen vascular disease.
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- Patient cannot undergo prostate MRI.
- Patient cannot undergo prostate fiducial marker placement.
- Patient has ongoing receipt of cytotoxic chemotherapy (androgen deprivation therapy is allowed).
Trial locations and contacts
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Claire McCann, PhD contact
8 sites in 3 countries
United States5 sites, 3 recruiting
- Active, not recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
- Recruiting
Duarte Cancer Center
Duarte, California, 91010
Percy Lee, MD, 833-672-4068, percylee@coh.org
Percy Lee, MD
- Recruiting
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
Percy Lee, MD, 833-672-4068, percylee@coh.org
Percy Lee, MD
- Active, not recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63110
Lindsey Mayer, CCRP, 314-482-9202, lindseymayer@wustl.edu
James Randall, MD
Germany2 sites, 2 recruiting
- Recruiting
Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital)
Homburg, Saarland, 66421
Markus Hecht, MD, 0049 6841 16 24874, markus.hecht.clinicaltrials@uks.eu
Wiebke Pirschel, MSc, 0049 6841 16 24874, wiebke.pirschel@uks.eu
- Recruiting
Klinikum der Landeshauptstadt Stuttgart gKAöR
Stuttgart, Baden-Wurttemberg, 70174
Danilo Trijic, MD, 04971127854668, D.Trijic@klinikum-stuttgart.de
Marc Münter, MD, 04971127834201, M.Muenter@klinikum-stuttgart.de
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
Marta Barrado Los Arcos, MD PhD, 0034-848-488482, marta.barrado.losarcos@navarra.es
Elena Villafranca Iturre, MD, 0034-848-488482, elena.villafranca.iturre@navarra.es
About this study
Official title: Daily Adaptive Stereotactic Body Radiation Therapy for Prostate Cancer With Urethral Sparing: A Prospective Trial Using an Individualized Approach to Reduce Urinary Toxicity
This trial is a prospective, single-arm, multi-center clinical trial designed to assess whether adaptive radiotherapy with urethral sparing for low to intermediate risk localized prostate cancer will translate into a decreased rate of patient reported acute urinary side effects, as measured by the patient reported EPIC-26 questionnaire, compared with the historically reported rate for non-adaptive, non-urethral sparing prostate SBRT.
- Conditions
- Prostate Cancer
- Being tested
- Daily adaptive SBRT with urethral sparing
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily adaptive SBRT with urethral sparingDevice
The radiation plan for each daily fraction is adapted from the initial plan based on cone beam CT imaging acquired while the participant is laying on the treatment machine.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive SBRT with Urethral Sparing | Experimental | Daily adaptive stereotactic body radiation therapy delivering 40 Gy in 5 fractions to the prostate while delivery 35-36 Gy in 5 fractions to the urethra. Receives: Device: Daily adaptive SBRT with urethral sparing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported acute urinary toxicity
Minimum clinically important change (MCIC) status in patient-reported urinary QOL, as determined by the worst change reported by each subject in their EPIC-26 urinary domain scores.
Measured: 90 days after end of SBRT
Secondary outcomes (13)
Freedom from biochemical recurrence
Rate of biochemical recurrence free survival, as determined by the Phoenix definition (PSA level of 2 ng/ml or more higher than the lowest post-SBRT value)
Measured: 5 years after end of SBRT
Patient-reported quality of life issues related to prostate cancer.
Patient-reported quality of life changes during and after adaptive prostate SBRT treatment using the Expanded Prostate Cancer Index Composite Short Form (EPIC-26) questionnaire.
Measured: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT
Patient-reported erectile dysfunction symptoms
Patient-reported erectile dysfunction symptoms before, during and after adaptive prostate SBRT treatment using the Sexual Health Inventory for Men (SHIM) questionnaire.
Measured: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT
Patient-reported urinary symptoms
Patient-reported urinary symptoms before, during and after adaptive prostate SBRT treatment using the International Prostate Symptom Score (IPSS) questionnaire.
Measured: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT
Patient-reported overall quality of life
Patient-reported overall quality of life before, during and after adaptive prostate SBRT treatment using the EQ-5D-5L questionnaire.
Measured: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT
Physician-reported toxicities
Physician-reported CTCAE v 5.0 adverse events
Measured: During treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT
Alpha-blocker medication use
Change in use of alpha-blocker medications for urinary symptoms
Measured: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT
Metastasis-free survival
Metastasis-free survival
Measured: 5 years after end of SBRT
Prostate-cancer specific mortality
Prostate-cancer specific mortality
Measured: 5 years after end of SBRT
Overall survival
Overall survival
Measured: 5 years after end of SBRT
Workflow metrics of adaptive SBRT for prostate cancer
Includes the time on table and frequency of using the adapted vs. non-adapted treatment plan for each fraction.
Measured: 2 weeks after start of SBRT
Target and OAR dosimetry
Improvement in target coverage and/or reduction in dose to critical organs at risk in the adapted plan compared to the non-adaptive planned dosimetry
Measured: 2 weeks after start of SBRT
Impact of rectal spacers
Physician reported toxicity and patient reported outcomes with or without implanted resorbable rectal spacer
Measured: Enrollment through 5 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start13 Apr 2023
- Primary completionJan 2027 (estimated)
- Study completionOct 2031 (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.
- 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
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Varian, a Siemens Healthineers Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Leeman, MD, Principal investigator, Brigham and Women's HospitalJeremy Bredfeldt, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804318
- Sponsor's protocol ID
- VAR-2021-10
- Acronym
- ARTIA-Prostate
- Status last verified
- Sep 2026
- First submitted
- 10 Mar 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Adaptive Stereotactic Body Radiation Therapy for Prostate Cancer With Urethral Sparing: A Prospective Trial Using an Individualized Approach to Reduce Urinary Toxicity
- ClinicalTrials.gov ID
- NCT05804318
- Acronym / sponsor ID
- ARTIA-Prostate / VAR-2021-10
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 7 Apr 2023 (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.
This trial is a prospective, single-arm, multi-center clinical trial designed to assess whether adaptive radiotherapy with urethral sparing for low to intermediate risk localized prostate cancer will translate into a decreased rate of patient reported acute urinary side effects, as measured by the patient reported EPIC-26 questionnaire, compared with the historically reported rate for non-adaptive, non-urethral sparing prostate SBRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptive SBRT with Urethral Sparing | Experimental | Device: Daily adaptive SBRT with urethral sparingDaily adaptive stereotactic body radiation therapy delivering 40 Gy in 5 fractions to the prostate while delivery 35-36 Gy in 5 fractions to the urethra. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient has NCCN low or intermediate risk prostate cancer that is biopsy proven.
- Prostate volume is ≤80cc as assessed by MRI prior to radiotherapy.
- AUA/IPSS score is ≤ 15.
- ECOG performance status is ≤2 (or Karnofsky score is ≥60%).
- Patient has no PIRADS 4 or 5 lesion on prostate MRI contacting the urethra (determined at physician discretion).
Key exclusion criteria (9 listed)
- Patient has baseline grade ≥3 GI or GU toxicity
- Patient has had prior overlapping pelvic radiotherapy.
- Patient has had prior transurethral resection of the prostate, prostate HIFU, or cryoablation.
- Patient has node positive prostate cancer.
- Patient has extracapsular extension (capsular abutment is permitted).
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 |
|---|---|---|
| Daily adaptive SBRT with urethral sparingThe radiation plan for each daily fraction is adapted from the initial plan based on cone beam CT imaging acquired while the participant is laying on the treatment machine. | Device | Adaptive SBRT with Urethral Sparing |
Primary outcome
Patient-reported acute urinary toxicity
Time frame: 90 days after end of SBRT
Minimum clinically important change (MCIC) status in patient-reported urinary QOL, as determined by the worst change reported by each subject in their EPIC-26 urinary domain scores.
13 secondary outcomes
Freedom from biochemical recurrence
Time frame: 5 years after end of SBRT
Patient-reported quality of life issues related to prostate cancer.
Time frame: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT
Patient-reported erectile dysfunction symptoms
Time frame: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT
Patient-reported urinary symptoms
Time frame: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT
Patient-reported overall quality of life
Time frame: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT
Physician-reported toxicities
Time frame: During treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT
Alpha-blocker medication use
Time frame: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT
Metastasis-free survival
Time frame: 5 years after end of SBRT
Prostate-cancer specific mortality
Time frame: 5 years after end of SBRT
Overall survival
Time frame: 5 years after end of SBRT
Workflow metrics of adaptive SBRT for prostate cancer
Time frame: 2 weeks after start of SBRT
Target and OAR dosimetry
Time frame: 2 weeks after start of SBRT
Impact of rectal spacers
Time frame: Enrollment through 5 year follow up
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 9 Sep 2026.
- 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.
Claire McCann, PhD contact
Jonathan Leeman, MD principal investigator
Brigham and Women's Hospital
Jeremy Bredfeldt, PhD principal investigator
Brigham and Women's Hospital
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily adaptive SBRT with urethral sparing in people with Prostate Cancer, run by Varian, a Siemens Healthineers Company at 8 sites in 3 countries.
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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Germany, Spain. 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?
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 Sean Davidson, MASc (1-437-991-8294, sean.davidson@siemens-healthineers.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported acute urinary toxicity (time frame: 90 days after end of SBRT). 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 9 Sep 2026.