Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer (ARTIA-Prostate)

Varian

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Device: Daily adaptive SBRT with urethral sparing

Study type: Interventional

Funder types: Industry

Identifiers

NCT05804318

VAR-2021-10

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

132 participants in 1 patient group

Adaptive SBRT with Urethral Sparing

Experimental group

Description:

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.

Treatment:

Device: Daily adaptive SBRT with urethral sparing