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NCT07251829Not yet recruitingPhase 2

Neoadjuvant Embolization and Cytoreduction in Prostate Cancer

Neoadjuvant Embolization and Cytoreduction to Ameliorate Radiotherapy Toxicity in Prostate Cancer

Source: ClinicalTrials.gov · Last updated 26 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
35 (estimated)
First submitted
19 Nov 2025
Start date
Feb 2026
Primary completion date
Jul 2027
Lead sponsor
Srinivas Raman
NCT number
NCT07251829

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 35
  • From Feb 2026 to the primary completion date, Jul 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous prostate treatment (TURP, Laser therapies, MISTs)
  • 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.

Other illness

  • 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.
  • Hypersensitivity reactions to contrast material not manageable with prophylaxis.

Other

  • Baseline (pre-PAE) IPSS storage/voiding ratio ≥ 1
  • Chronic urinary retention requiring use of indwelling urinary catheter.
  • Glomerular filtration rates less than 40 mL/min (unless on dialysis).
  • Bilateral internal iliac arterial occlusion.

Who the study is looking for

  • 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.

Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.