Prostate Cancer
Conditions
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.
Interventions
DEVICEDaily adaptive SBRT with urethral sparing
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.
Sponsors
Varian, a Siemens Healthineers Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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 |
| 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 |
| 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 |
| Overall survival | 5 years after end of SBRT | Overall survival |
| 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. |
| 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 |
| Impact of rectal spacers | Enrollment through 5 year follow up | Physician reported toxicity and patient reported outcomes with or without implanted resorbable rectal spacer |
Countries
Germany, Spain, United States
Contacts
CONTACTSean Davidson, MASc
CONTACTClaire McCann, PhD
PRINCIPAL_INVESTIGATORJonathan Leeman, MD
Brigham and Women's Hospital
PRINCIPAL_INVESTIGATORJeremy Bredfeldt, PhD
Brigham and Women's Hospital
Outcome results
None listed