Recruiting NCT05804318
Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Daily adaptive SBRT with urethral sparing.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Germany, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Daily Adaptive Stereotactic Body Radiation Therapy for Prostate Cancer With Urethral Sparing: A Prospective Trial Using an Individualized Approach to Reduce Urinary Toxicity
Overview
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.
Interventions
- Device Daily 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.
Primary outcome measures
- Patient-reported acute urinary toxicity [Time frame: 90 days after end of SBRT]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- Duarte Cancer Center — Duarte
- City of Hope Orange County Lennar Foundation Cancer Center — Irvine
- Brigham and Women's Hospital — Boston
- Washington University in St. Louis — St Louis
- Fox Chase Cancer Center — Philadelphia
Germany · 2 centers
- Klinikum der Landeshauptstadt Stuttgart gKAöR — Stuttgart
- Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital) — Homburg
Spain · 1 center
- Hospital Universitario de Navarra — Pamplona
Identifiers
NCT: NCT05804318 · VAR-2021-10