Clinical trial · Interventional
Neoadjuvant Embolization and Cytoreduction in Prostate Cancer
Neoadjuvant Embolization and Cytoreduction to Ameliorate Radiotherapy Toxicity in 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 goal of this clinical trial is to find out whether prostate artery embolization (PAE) can help prevent or lessen urinary side effects caused by radiotherapy (RT) in people with prostate cancer, especially those who have larger prostates or urinary symptoms before treatment. The main questions this study aims to answer are: * Does PAE before RT reduce the severity of urinary side effects from RT? * Does PAE affect the rates of genitourinary (GU) or gastrointestinal (GI) side effects after RT? Researchers will look at changes in urinary symptoms from the start of the study to 6 months after PAE. They will also record any GU or GI side effects related to RT. Participants will receive prostate artery embolization before starting radiotherapy, and complete questionnaires and assessments about GU and GI functions before and after treatment.
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 Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostatic Artery Embolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PAE
- description
- Neoadjuvant PAE before RT
- interventionNames
- Procedure: Prostatic Artery Embolization
Primary outcomes (1)
- measure
- Change in LUTS symptoms measured by the IPSS at 6 months post-PAE
- timeFrame
- From enrollment to the 12 months after PAE
Secondary outcomes (10)
- measure
- Rates of Grade ≥2 GU and GI RT toxicity as assessed by CTCAE v5.0
- timeFrame
- From enrollment to 12 months after PAE
- measure
- Rates of PAE intraoperative and postoperative adverse events as assessed by Clavien-Dindo and CTCAE v5.0
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed prostate adenocarcinoma with planned RT to the prostate * Baseline (pre-PAE) prostate volume ≥ 50 cc * Baseline (pre-PAE) IPSS ≥ 15 * If planned or ongoing ADT and/or 5-alpha reductase inhibitor (5ARI), patient should be on therapy for at least 12 weeks, and meet prostate volume and pre-PAE IPSS criteria at the time of enrollment. Exclusion Criteria: * Baseline (pre-PAE) IPSS storage/voiding ratio ≥ 1 * Previous prostate treatment (TURP, Laser therapies, MISTs) * Chronic urinary retention requiring use of indwelling urinary catheter. * Neurogenic bladder or other neurological disorder that is impacting bladder function (e.g., multiple sclerosis, Parkinson's disease, spinal cord injuries, etc.). * Active urinary tract infections or recurrent urinary tract infections (\>2/year), prostatitis, or interstitial cystitis. * Receipt of beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week of study treatment AND patient has not been on the same drug dosage for 6 months with a stable voiding pattern. * Hypersensitivity reactions to contrast material not manageable with prophylaxis. * Glomerular filtration rates less than 40 mL/min (unless on dialysis). * Bilateral internal iliac arterial occlusion.
References
Publications (0)
Data not yet available