RecruitingNot ApplicableNCT05804318

Daily Adaptive Radiation Therapy Using an Individualized Approach 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

Sponsor

Varian, a Siemens Healthineers Company

Enrollment

132 participants

Start Date

Apr 13, 2023

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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

Sex: MALEMin Age: 18 Years

Inclusion Criteria8

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.

Exclusion Criteria9

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).

Interventions

DEVICEDaily 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.