Daily Adaptive Stereotactic Body Radiation Therapy for Prostate Cancer With Urethral Sparing: A Prospective Trial Using an Individualized Approach to Reduce Urinary Toxicity

Varian, a Siemens Healthineers Company12 个研究点分布在 3 个国家目标入组 132 人2023年4月13日

适应症Prostate Cancer

干预措施Daily adaptive SBRT with urethral sparing

概览

阶段: 不适用
干预措施: Daily adaptive SBRT with urethral sparing
疾病 / 适应症: Prostate Cancer
发起方: Varian, a Siemens Healthineers Company
入组人数: 132
试验地点: 12
主要终点: Patient-reported acute urinary toxicity
状态: 招募中
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2023年4月13日

结束日期

2031年7月1日

最后更新

2个月前

研究类型

Interventional

研究设计

Single Group

性别

Male

研究者

发起方

Varian, a Siemens Healthineers Company

责任方

Sponsor

入排标准

入选标准

•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 ≤
•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.

排除标准

•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).

研究组 & 干预措施

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.

干预措施: Daily adaptive SBRT with urethral sparing

结局指标

主要结局

Patient-reported acute urinary toxicity

时间窗: 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.

次要结局

Metastasis-free survival(5 years after end of SBRT)
Prostate-cancer specific mortality(5 years after end of SBRT)
Workflow metrics of adaptive SBRT for prostate cancer(2 weeks after start of SBRT)
Freedom from biochemical recurrence(5 years after end of SBRT)
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 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)
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)
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 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)
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)
Target and OAR dosimetry(2 weeks after start of SBRT)
Overall survival(5 years after end of SBRT)
Impact of rectal spacers(Enrollment through 5 year follow up)