Neoadjuvant Embolization and Cytoreduction in Prostate Cancer

NCT ID: NCT07251829

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PAE

Neoadjuvant PAE before RT

Group Type: EXPERIMENTAL

Prostatic Artery Embolization

Intervention Type: PROCEDURE

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

Interventions

Prostatic Artery Embolization

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Srinivas Raman

OTHER

Sponsor Role: lead

Responsible Party

Srinivas Raman

MD, FRCPC

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

NECTAR

Identifier Type: -

Identifier Source: org_study_id