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NCT Number: NCT07251829

Neoadjuvant Embolization and Cytoreduction in Prostate Cancer

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.

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Key information

Conditions

Prostate Adenocarcinoma

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prostatic Artery Embolization

Procedure

PAE is a minimally invasive procedure that involves embolizing the arteries supplying the prostate, leading to its shrinkage.

Primary outcomes

  1. Change in LUTS symptoms measured by the IPSS at 6 months post-PAE

    Time frame: From enrollment to the 12 months after PAE

Secondary outcomes

  1. Rates of Grade ≥2 GU and GI RT toxicity as assessed by CTCAE v5.0

    Time frame: From enrollment to 12 months after PAE

  2. Rates of PAE intraoperative and postoperative adverse events as assessed by Clavien-Dindo and CTCAE v5.0

    Time frame: From the start of PAE to 12 months after PAE

  3. Prostatic Specific antigen (PSA) at 6 months post-PAE

    Time frame: From enrollment to 12 months after PAE

  4. Change in prostate volume calculated by TRUS at 6 months post-PAE

    Time frame: From enrollment to 12 months after PAE

  5. Change in peak urinary flow rate (Qmax, ml/s) at 6 months post-PAE

    Time frame: From enrollment to 6 months after PAE

  6. Change in postvoid residual urine (PVR, ml) at 6 months post-PAE

    Time frame: From enrollment to 6 months after PAE

  7. Change in bladder and rectum mean RT dose from pre-PAE to pre-RT simulation scan

    Time frame: From pre-PAE simulation scan to pre-RT simulation scan

  8. Urinary quality of life assessed by IPSS QoL scores

    Time frame: From enrollment to 12 months after PAE

  9. Rate of local re-intervention for LUTS

    Time frame: From enrollment to 6 months after PAE

  10. Erectile dysfunction assessed by the International Index of Erectile Function (IIEF-5) questionnaire

    Time frame: From enrollment to 12 months after PAE

Sponsors and collaborators

Lead sponsor

Srinivas Raman

Other

Registry information

Official study title

Neoadjuvant Embolization and Cytoreduction to Ameliorate Radiotherapy Toxicity in Prostate Cancer

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 26, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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