Clinical trial · Interventional
Evaluating Tolerability of ePUHRT With Brachytherapy Boost
Evaluating Tolerability of Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT) With High Dose Rate Brachytherapy Boost for Unfavorable and Higher Risk Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the tolerability and toxicity of combining two radiation therapy methods for prostate cancer: Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT), which is an external beam radiotherapy with High Dose Rate Brachytherapy Boost (form of internal radiation where a cancer doctor implants a small plastic tube or balloon (catheter) in the tumor).
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 |
|---|---|---|---|
| ePURT 5Gy x 5 fractions with single HDR boost of 15Gy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ePURT 5Gy x 5 fractions with single HDR boost of 15Gy
- description
- Single arm non-randomized non-inferiority study exploring tolerability of ePURT 5Gy x 5 fractions delivered on noncontiguous weekdays with single HDR boost of 15Gy.
- interventionNames
- Radiation: ePURT 5Gy x 5 fractions with single HDR boost of 15Gy
Primary outcomes (1)
- measure
- Percentage of participants with acute grade ≥ 2 GU toxicity
- timeFrame
- 3 months
- description
- Physician-reported acute grade ≥ 2 GU toxicity at 3 months post ePUHRT with HDR boost measured by CTCAE version 5.
Secondary outcomes (2)
- measure
- Percentage of participants with acute grade ≥ 2 GI toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥ 18 years old at the time of informed consent 2. Capable of providing informed consent and HIPAA authorization 3. Karnofsky performance score ≥ 70 4. Pathologically confirmed unfavorable intermediate, high, and very high-risk prostate cancer per treating physician 5. Candidate plans to undergo the standard of care prostate high dose brachytherapy boost procedure Exclusion Criteria: 1. Prior pelvic irradiation treatment 2. Prior rectal surgery which precludes instrumentation with rectal ultrasound probe. 3. Evidence of nodal or distant disease on screening diagnostic work up. 4. Prior prostatectomy, Holmium laser enucleation of the prostate or transurethral resection of the prostate procedure 5. International Prostate Symptom Score (IPSS) score \> 16 despite medical therapy
References
Publications (0)
Data not yet available