Clinical trial · Interventional
Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer
Daily Adaptive Stereotactic Body Radiation Therapy for Prostate Cancer With Urethral Sparing: A Prospective Trial Using an Individualized Approach to Reduce Urinary Toxicity
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daily adaptive SBRT with urethral sparing | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adaptive SBRT with Urethral Sparing
- description
- 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.
- interventionNames
- Device: Daily adaptive SBRT with urethral sparing
Primary outcomes (1)
- measure
- Patient-reported acute urinary toxicity
- timeFrame
- 90 days after end of SBRT
- description
- 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 outcomes (13)
- measure
- Freedom from biochemical recurrence
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available