Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
Varian, a Siemens Healthineers Company
Study ID
NCT05804318
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Apr 13, 2023
Status verified
May 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2031

Study Design

Enrollment
132 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Duarte Cancer CenterDuarteCalifornia91010
Percy Lee, MD
[email protected]
833-672-4068
Percy Lee, MD (PRINCIPAL_INVESTIGATOR)
City of Hope Orange County Lennar Foundation Cancer CenterIrvineCalifornia92618
Percy Lee, MD
[email protected]
833-672-4068
Percy Lee, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115-
Washington University in St. LouisSt LouisMissouri63110
Lindsey Mayer, CCRP
[email protected]
314-482-9202
James Randall, MD (PRINCIPAL_INVESTIGATOR)
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-

Find similar trials in Duarte, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Duarte Cancer Center· Duarte, CACity of Hope Orange County Lennar Foundation Cancer Center· Irvine, CABrigham and Women's Hospital· Boston, MAWashington University in St. Louis· St Louis, MOFox Chase Cancer Center· Philadelphia, PA

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