Neoadjuvant Embolization and Cytoreduction in Prostate Cancer

NCT07251829 | Not Yet Recruiting Phase 2

• 1 other identifier: NECTAR
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

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

  From enrollment to the 12 months after PAE

Secondary Outcomes (10)

• 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

Study Arms (1)

PAE

EXPERIMENTAL

Neoadjuvant PAE before RT

Procedure: Prostatic Artery Embolization

Interventions

Prostatic Artery Embolization PROCEDURE

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

PAE

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Srinivas Raman: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, FRCPC

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 26, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11