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Not yet recruiting NCT07251829

Neoadjuvant Embolization and Cytoreduction in Prostate Cancer

Phase II Interventional Prostate Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prostatic Artery Embolization.
Who it may be relevant to
Registry conditions: Prostate Adenocarcinoma. Basic parameters: No limits · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Neoadjuvant Embolization and Cytoreduction to Ameliorate Radiotherapy Toxicity in Prostate Cancer

Overview

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.

Interventions

  • Procedure Prostatic Artery Embolization
    PAE is a minimally invasive procedure that involves embolizing the arteries supplying the prostate, leading to its shrinkage.

Primary outcome measures

  • Change in LUTS symptoms measured by the IPSS at 6 months post-PAE [Time frame: From enrollment to the 12 months after PAE]
Secondary outcome measures (10)
  • Rates of Grade ≥2 GU and GI RT toxicity as assessed by CTCAE v5.0 [Time frame: From enrollment to 12 months after PAE]
  • Rates of PAE intraoperative and postoperative adverse events as assessed by Clavien-Dindo and CTCAE v5.0 [Time frame: From the start of PAE to 12 months after PAE]
  • Prostatic Specific antigen (PSA) at 6 months post-PAE [Time frame: From enrollment to 12 months after PAE]
  • Change in prostate volume calculated by TRUS at 6 months post-PAE [Time frame: From enrollment to 12 months after PAE]
  • Change in peak urinary flow rate (Qmax, ml/s) at 6 months post-PAE [Time frame: From enrollment to 6 months after PAE]
  • Change in postvoid residual urine (PVR, ml) at 6 months post-PAE [Time frame: From enrollment to 6 months after PAE]
  • Change in bladder and rectum mean RT dose from pre-PAE to pre-RT simulation scan [Time frame: From pre-PAE simulation scan to pre-RT simulation scan]
  • Urinary quality of life assessed by IPSS QoL scores [Time frame: From enrollment to 12 months after PAE]
  • Rate of local re-intervention for LUTS [Time frame: From enrollment to 6 months after PAE]
  • Erectile dysfunction assessed by the International Index of Erectile Function (IIEF-5) questionnaire [Time frame: From enrollment to 12 months after PAE]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07251829 · NECTAR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗