Neoadjuvant Embolization and Cytoreduction in Prostate Ca... | NCT07251829

Studies
Neoadjuvant Embolization and Cytoreduction in Prostate Cancer

NCT07251829

Sponsor

Srinivas Raman

Status

Not yet recruiting

Last Update Posted

Nov 26, 2025Actual

Enrollment

35Estimated

Phase

Phase 2

Conditions

Prostate Adenocarcinoma

Interventions

Prostatic Artery Embolization

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2026Estimated

Primary Completion Date

Jul 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Nov 19, 2025

First Submission Date that Met QC Criteria

Nov 19, 2025

First Posted Date

Nov 26, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2025

Last Update Posted Date

Nov 26, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PAE	Experimental	Neoadjuvant PAE before RT	Procedure: Prostatic Artery Embolization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prostatic Artery Embolization	Procedure	PAE is a minimally invasive procedure that involves embolizing the arteries supplying the prostate, leading to its shrinkage.	PAE

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided