Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

NCT05804318 | Recruiting FDA Device

• 1 other identifier: VAR-2021-10
• Study Type: interventional
• Target: 132
• Locations: 3 countries
• Sites: 7

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days after end of SBRT

Secondary Outcomes (13)

• Freedom from biochemical recurrence

  5 years after end of SBRT

• Patient-reported quality of life issues related to prostate cancer.

  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

  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

  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

  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

Other Outcomes (1)

• Decipher prognostic ability

  5 years after end of SBRT

Study Arms (1)

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.

Device: Daily adaptive SBRT with urethral sparing

Interventions

Daily adaptive SBRT with urethral sparing DEVICE

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.

Adaptive SBRT with Urethral Sparing

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Varian, a Siemens Healthineers Company: lead

Study Sites (7)

Duarte Cancer Center

Duarte, California, 91010, United States

RECRUITING

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, 92618, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

ACTIVE NOT RECRUITING

Washington University in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

ACTIVE NOT RECRUITING

Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital)

Homburg, Saarland, 66421, Germany

RECRUITING

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jonathan Leeman, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Jeremy Bredfeldt, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean Davidson, MASc

CONTACT

1-437-991-8294; sean.davidson@varian.com

Claire McCann, PhD

CONTACT

claire.mccann@varian.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: April 7, 2023
• Study Start: April 13, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2031
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); US (5); ES (1)