Neoadjuvant Embolization and Cytoreduction in Prostate Cancer

Srinivas Raman

Status and phase

Not yet enrolling

Phase 2

Conditions

Prostate Adenocarcinoma

Treatments

Procedure: Prostatic Artery Embolization

Study type

Interventional

Funder types

Other

Identifiers

NCT07251829

NECTAR

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

Male

Volunteers

No Healthy Volunteers

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.