Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer
NCT ID: NCT05804318
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
132 participants
INTERVENTIONAL
2023-04-13
2031-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Adaptive SBRT with Urethral Sparing
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.
Daily adaptive SBRT with urethral sparing
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.
Interventions
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Daily adaptive SBRT with urethral sparing
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.
Eligibility Criteria
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Inclusion Criteria
2. Prostate volume is ≤80cc as assessed by MRI prior to radiotherapy.
3. AUA/IPSS score is ≤ 15.
4. ECOG performance status is ≤2 (or Karnofsky score is ≥60%).
5. Patient has no PIRADS 4 or 5 lesion on prostate MRI contacting the urethra (determined at physician discretion).
6. Patient has the ability to complete required patient questionnaires.
7. Patient age ≥ 18 years (or greater than the local age of majority).
8. Patient has the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
2. Patient has had prior overlapping pelvic radiotherapy.
3. Patient has had prior transurethral resection of the prostate, prostate HIFU, or cryoablation.
4. Patient has node positive prostate cancer.
5. Patient has extracapsular extension (capsular abutment is permitted).
6. Patient has active inflammatory bowel disease or active collagen vascular disease.
7. Patient cannot undergo prostate MRI.
8. Patient cannot undergo prostate fiducial marker placement.
9. Patient has ongoing receipt of cytotoxic chemotherapy (androgen deprivation therapy is allowed).
18 Years
MALE
No
Sponsors
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Varian, a Siemens Healthineers Company
INDUSTRY
Responsible Party
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Principal Investigators
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Jonathan Leeman, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Jeremy Bredfeldt, PhD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Duarte Cancer Center
Duarte, California, United States
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Washington University in St. Louis
St Louis, Missouri, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital)
Homburg, Saarland, Germany
Hospital Universitario de Navarra
Pamplona, Navarre, Spain
Countries
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Central Contacts
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Facility Contacts
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Percy Lee, MD
Role: primary
Percy Lee, MD
Role: primary
Sinead Christensen
Role: primary
Kris Zhai
Role: backup
Lindsey Mayer, CCRP
Role: primary
Markus Hecht, MD
Role: primary
Wiebke Pirschel, MSc
Role: backup
Marta Barrado Los Arcos, MD PhD
Role: primary
Elena Villafranca Iturre, MD
Role: backup
Other Identifiers
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VAR-2021-10
Identifier Type: -
Identifier Source: org_study_id