Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

Clinicaltrials.gov ID: NCT05804318
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 132

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Jonathan Leeman, MD

Eligibility Criteria

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 Plan

Adaptive SBRT with Urethral Sparing

EXPERIMENTAL

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.

  • DEVICE:

    Daily adaptive SBRT with urethral sparing

    Description:

    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.

Outcome Measures

Primary Outcome Measures

Patient-reported acute urinary toxicity

Time Frame: 90 days after end of SBRT

Secondary Outcome Measures

Freedom from biochemical recurrence

Time Frame: 5 years after end of SBRT

Patient-reported quality of life issues related to prostate cancer.

Time Frame: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT

Patient-reported erectile dysfunction symptoms

Time Frame: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT

Patient-reported urinary symptoms

Time Frame: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT

Patient-reported overall quality of life

Time Frame: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT

Physician-reported toxicities

Time Frame: During treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT

Alpha-blocker medication use

Time Frame: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT

Metastasis-free survival

Time Frame: 5 years after end of SBRT

Prostate-cancer specific mortality

Time Frame: 5 years after end of SBRT

Overall survival

Time Frame: 5 years after end of SBRT

Workflow metrics of adaptive SBRT for prostate cancer

Time Frame: 2 weeks after start of SBRT

Target and OAR dosimetry

Time Frame: 2 weeks after start of SBRT

Impact of rectal spacers

Time Frame: Enrollment through 5 year follow up

Timeline

  • Last Updated
    April 24, 2024
  • Start Date
    April 7, 2023
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    March 1, 2030

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