Daily Adaptive Stereotactic Body Radiation Therapy for Prostate Cancer with Urethral Sparing: A Prospective Trial Using an Individualized Approach to Reduce Urinary Toxicity (ARTIA-Prostate)

Protocol # :
Prostate Cancer
Not Applicable
Disease Sites
Principal Investigator
Leeman, Jonathan
Site Research Nurses
Mann, Eileen, Marie
Mann, Eileen, Marie
Spicer, Beverly, A.
Spicer, Beverly, A.

Trial Description

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 Requirements

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

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