To hear about similar clinical trials, please enter your email below
Trial Title:
Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer
NCT ID:
NCT05804318
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
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.
Arm group label:
Adaptive SBRT with Urethral Sparing
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.
Criteria for 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).
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sinead Christensen
Phone:
617-582-8264
Email:
smchristensen@bwh.harvard.edu
Contact backup:
Last name:
Kris Zhai
Phone:
(617) 582-8996
Email:
bkzhai@bwh.harvard.edu
Investigator:
Last name:
Jonathan Leeman, MD
Email:
Principal Investigator
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Active, not recruiting
Start date:
April 13, 2023
Completion date:
March 2030
Lead sponsor:
Agency:
Varian, a Siemens Healthineers Company
Agency class:
Industry
Source:
Varian, a Siemens Healthineers Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05804318
