Daily adaptive radiation therapy for prostate cancer

Daily Adaptive Stereotactic Body Radiation Therapy for Prostate Cancer With Urethral Sparing: A Prospective Trial Using an Individualized Approach to Reduce Urinary Toxicity

This study is testing a new daily radiation treatment for men with low to intermediate risk prostate cancer to see if it can reduce urinary side effects while still effectively targeting the cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Varian, a Siemens Healthineers Company (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 7 sites (Duarte, California and 6 other locations)
• Trial ID: NCT05804318 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of daily adaptive stereotactic body radiation therapy (SBRT) with a focus on sparing the urethra in patients with low to intermediate risk localized prostate cancer. It aims to reduce the incidence of acute urinary side effects as reported by patients using the EPIC-26 questionnaire. The study is designed as a prospective, single-arm, multi-center trial, meaning it will involve multiple locations and will assess outcomes based on patient feedback. Participants will receive individualized treatment plans tailored to their specific prostate cancer characteristics.

Who should consider this trial

Good fit: Ideal candidates include men aged 18 and older with biopsy-proven NCCN low or intermediate risk prostate cancer and specific eligibility criteria regarding prostate volume and urinary function.

Not a fit: Patients with high-grade gastrointestinal or genitourinary toxicity, prior pelvic radiotherapy, or node-positive prostate cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce urinary side effects for patients undergoing radiation therapy for prostate cancer.

How similar studies have performed: While adaptive radiation therapy is an evolving field, this specific approach focusing on urethral sparing in prostate cancer is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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).

Where this trial is running

Duarte, California and 6 other locations

• Duarte Cancer Center — Duarte, California, United States (Recruiting)
• City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California, United States (Recruiting)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (Active_not_recruiting)
• Washington University in St. Louis — St Louis, Missouri, United States (Recruiting)
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (Active_not_recruiting)
• Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital) — Homburg, Saarland, Germany (Recruiting)
• Hospital Universitario de Navarra — Pamplona, Navarre, Spain (Recruiting)

Study contacts

• Principal investigator: Jonathan Leeman, MD — Brigham and Women's Hospital
• Study coordinator: Sean Davidson, MASc

Conditions Prostate Cancer