Recruiting

Adaptive Radiation Therapy

Sponsor:

Varian, a Siemens Healthineers Company

Code:

NCT05804318

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Daily adaptive SBRT with urethral sparing

Study Details

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

Study ID

NCT05804318

Start date

Apr 13, 2023

Status verified date

May, 2026

Completion date

Jul, 2031

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

132 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • Patient-reported acute urinary toxicity [ Time Frame: 90 days after end of SBRT ]

Central Contacts and Locations

Locations

Duarte Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Principal Investigator:

Percy Lee, MD

City of Hope Orange County Lennar Foundation Cancer Center

Recruiting

Irvine, California, United States, 92618

Contacts

Principal Investigator:

Percy Lee, MD

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

James Randall, MD

More Information

Sponsor

Varian, a Siemens Healthineers Company

Last update posted

May 28, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Varian, a Siemens Healthineers Company on 2026-05-28.