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NCT05804318NARecruiting

Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

Varian, a Siemens Healthineers Company

Start Date

4/13/2023

Completion Date

7/1/2031

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 EPIC-26 questionnaire, compared with the historically reported rate for non-adaptive, non-urethral sparing prostate SBRT.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Patient has NCCN low or intermediate risk prostate cancer that is biopsy proven. 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: 1. Patient has baseline grade ≥3 GI or GU toxicity 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).

Interventions

DEVICE

Daily adaptive SBRT with urethral sparing

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Conditions

Prostate Cancer

Locations

Duarte Cancer Center

Duarte, California 91010

United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California 92618

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

Washington University in St. Louis

St Louis, Missouri 63110

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania 19111

United States

Klinikum der Landeshauptstadt Stuttgart gKAöR

Stuttgart, Baden-Wurttemberg 70174

Germany

Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital)

Homburg, Saarland 66421

Germany

Hospital Universitario de Navarra

Pamplona, Navarre 31008

Spain