Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer
Conditions
Prostate CancerSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Sinead Christensen
- 617-582-8264
- [email protected]
Principal Investigator
- Jonathan Leeman, MD
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).
Study Plan
Adaptive SBRT with Urethral Sparing
EXPERIMENTAL
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.
DEVICE:
Daily adaptive SBRT with urethral sparingDescription:
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.
Outcome Measures
Primary Outcome Measures
Patient-reported acute urinary toxicity
Secondary Outcome Measures
Freedom from biochemical recurrence
Patient-reported quality of life issues related to prostate cancer.
Patient-reported erectile dysfunction symptoms
Patient-reported urinary symptoms
Patient-reported overall quality of life
Physician-reported toxicities
Alpha-blocker medication use
Metastasis-free survival
Prostate-cancer specific mortality
Overall survival
Workflow metrics of adaptive SBRT for prostate cancer
Target and OAR dosimetry
Impact of rectal spacers
Timeline
Last Updated
April 24, 2024Start Date
April 7, 2023Today
February 5, 2025Completion Date ( Estimated )
March 1, 2030
Sponsors of this trial
Lead Sponsor
Varian, a Siemens Healthineers Company