Neoadjuvant Embolization and Cytoreduction in Prostate Cancer

Neoadjuvant Embolization and Cytoreduction to Ameliorate Radiotherapy Toxicity 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Adenocarcinoma
• Intervention / Treatment: Procedure: Prostatic Artery Embolization

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PAE; Neoadjuvant PAE before RT	Procedure: Prostatic Artery Embolization; PAE is a minimally invasive procedure that involves embolizing the arteries supplying the prostate, leading to its shrinkage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in LUTS symptoms measured by the IPSS at 6 months post-PAE	From enrollment to the 12 months after PAE

Secondary Outcome Measures

Outcome Measure	Time Frame
Rates of Grade ≥2 GU and GI RT toxicity as assessed by CTCAE v5.0	From enrollment to 12 months after PAE
Rates of PAE intraoperative and postoperative adverse events as assessed by Clavien-Dindo and CTCAE v5.0	From the start of PAE to 12 months after PAE
Prostatic Specific antigen (PSA) at 6 months post-PAE	From enrollment to 12 months after PAE
Change in prostate volume calculated by TRUS at 6 months post-PAE	From enrollment to 12 months after PAE
Change in peak urinary flow rate (Qmax, ml/s) at 6 months post-PAE	From enrollment to 6 months after PAE
Change in postvoid residual urine (PVR, ml) at 6 months post-PAE	From enrollment to 6 months after PAE
Change in bladder and rectum mean RT dose from pre-PAE to pre-RT simulation scan	From pre-PAE simulation scan to pre-RT simulation scan
Urinary quality of life assessed by IPSS QoL scores	From enrollment to 12 months after PAE
Rate of local re-intervention for LUTS	From enrollment to 6 months after PAE
Erectile dysfunction assessed by the International Index of Erectile Function (IIEF-5) questionnaire	From enrollment to 12 months after PAE

Collaborators and Investigators

• Sponsor: Srinivas Raman

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NECTAR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No