Clinical trial NCT05804318: Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Varian, a Siemens Healthineers Company
Sponsor class: INDUSTRY
First posted: 2023-04-07
Enrollment: 132
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Patient-reported acute urinary toxicity
timeFrame: 90 days after end of SBRT
Secondary outcomes:
measure: Freedom from biochemical recurrence
timeFrame: 5 years after end of SBRT
measure: Patient-reported quality of life issues related to prostate cancer.
timeFrame: 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
measure: Patient-reported erectile dysfunction symptoms
timeFrame: 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
measure: Patient-reported urinary symptoms
timeFrame: 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
measure: Patient-reported overall quality of life
timeFrame: 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
measure: Physician-reported toxicities
timeFrame: 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
measure: Alpha-blocker medication use
timeFrame: 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
measure: Metastasis-free survival
timeFrame: 5 years after end of SBRT
measure: Prostate-cancer specific mortality
timeFrame: 5 years after end of SBRT
measure: Overall survival
timeFrame: 5 years after end of SBRT
measure: Workflow metrics of adaptive SBRT for prostate cancer
timeFrame: 2 weeks after start of SBRT
measure: Target and OAR dosimetry
timeFrame: 2 weeks after start of SBRT
measure: Impact of rectal spacers
timeFrame: Enrollment through 5 year follow up
Other outcomes:
measure: Decipher prognostic ability
timeFrame: 5 years after end of SBRT
Locations:
city: Irvine
country: United States
facility: City of Hope Orange County Lennar Foundation Cancer Center
state: California
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Navarre
Study officials:
affiliation: Brigham and Women's Hospital
name: Jonathan Leeman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Jeremy Bredfeldt, PhD
role: PRINCIPAL_INVESTIGATOR
References: