Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Device: Daily adaptive SBRT with urethral sparing
- Registration Number
- NCT05804318
- Lead Sponsor
- Varian, a Siemens Healthineers Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 132
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Adaptive SBRT with Urethral Sparing Daily adaptive SBRT with urethral sparing 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.
- Primary Outcome Measures
Name Time Method Patient-reported acute urinary toxicity 90 days after end of SBRT Minimum clinically important change (MCIC) status in patient-reported urinary QOL, as determined by the worst change reported by each subject in their EPIC-26 urinary domain scores.
- Secondary Outcome Measures
Name Time Method Metastasis-free survival 5 years after end of SBRT Metastasis-free survival
Prostate-cancer specific mortality 5 years after end of SBRT Prostate-cancer specific mortality
Workflow metrics of adaptive SBRT for prostate cancer 2 weeks after start of SBRT Includes the time on table and frequency of using the adapted vs. non-adapted treatment plan for each fraction.
Freedom from biochemical recurrence 5 years after end of SBRT Rate of biochemical recurrence free survival, as determined by the Phoenix definition (PSA level of 2 ng/ml or more higher than the lowest post-SBRT value)
Patient-reported quality of life issues related to prostate cancer. 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 quality of life changes during and after adaptive prostate SBRT treatment using the Expanded Prostate Cancer Index Composite Short Form (EPIC-26) questionnaire.
Patient-reported overall quality of life 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 before, during and after adaptive prostate SBRT treatment using the EQ-5D-5L questionnaire.
Alpha-blocker medication use 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 Change in use of alpha-blocker medications for urinary symptoms
Patient-reported erectile dysfunction symptoms 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 before, during and after adaptive prostate SBRT treatment using the Sexual Health Inventory for Men (SHIM) questionnaire.
Patient-reported urinary symptoms 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 before, during and after adaptive prostate SBRT treatment using the International Prostate Symptom Score (IPSS) questionnaire.
Physician-reported toxicities 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 CTCAE v 5.0 adverse events
Target and OAR dosimetry 2 weeks after start of SBRT Improvement in target coverage and/or reduction in dose to critical organs at risk in the adapted plan compared to the non-adaptive planned dosimetry
Overall survival 5 years after end of SBRT Overall survival
Impact of rectal spacers Enrollment through 5 year follow up Physician reported toxicity and patient reported outcomes with or without implanted resorbable rectal spacer
Trial Locations
- Locations (4)
Hospital Universitario de Navarra
🇪🇸Pamplona, Navarre, Spain
City of Hope Orange County Lennar Foundation Cancer Center
🇺🇸Irvine, California, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States