NCT05804318 · Varian, a Siemens Healthineers Company
Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer
(ARTIA-Prostate)
What this study is about
This trial is a forward-looking, single-treatment group$1, 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Patient cannot undergo prostate MRI.
- Patient cannot undergo prostate fiducial marker placement.
- Patient has ongoing receipt of cytotoxic chemotherapy (androgen deprivation therapy is allowed).
Where
- Duarte, California
- Irvine, California
- Boston, Massachusetts
- St Louis, Missouri
- Philadelphia, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 28, 2026 · Source of record for eligibility and locations