NCT05389202

Brief Summary

Over the last 5 years, prostate embolization has developed as a treatment for symptomatic prostate adenoma. This long, complex procedure is effective in 80% of cases. Currently there are no means of better selecting patients to avoid this long procedure in non-responders. The hypothesis is that prostate perfusion parameters are correlated with the efficacy of embolization. Studying these prostate perfusion parameters in perfusion CT and evaluating prostate Iodine load in dual energy computed tomography will make it easier to select those patients who are most likely to respond.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

May 12, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2024

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

1.7 years

First QC Date

May 11, 2022

Last Update Submit

March 7, 2025

Conditions

Prostate Cancer

Keywords

ProstateAdenomaEmbolization

Outcome Measures

Primary Outcomes (15)

  • Catheterized patients: Removal of the urinary catheter at 3 months

    Yes/No

    Month 3

  • Non-catheterized patients: 25% decrease in the International Prostate Symptom Score

    Yes/No

    Month 3

  • Non-catheterized patients: one point improvement in the Global Quality of Life Score.

    Yes/No

    Month 3

  • MRI perfusion parameters : Capillary permeability

    Measured in mL.mL tissue-1.min-1

    7 - 14 days before embolization

  • Scanner perfusion parameters : Capillary permeability

    Measured in mL.mL tissue-1.min-1

    Day 0 (on the day of embolization)

  • MRI perfusion parameters : Extracellular volume

    Measured in mL.mL tissue-1

    7 - 14 days before embolization

  • Scanner perfusion parameters : Extracellular volume

    Measured in mL.mL tissue-1

    Day 0 (on the day of embolization)

  • MRI perfusion parameters : Blood volume

    Measured in mL.mL tissue-1

    7 - 14 days before embolization

  • Scanner perfusion parameters : Blood volume

    Measured in mL.mL tissue-1

    Day 0 (on the day of embolization)

  • MRI perfusion parameters : Maximum slope

    Measured in ml.min-1

    7 - 14 days before embolization

  • Scanner perfusion parameters : Maximum slope

    Measured in ml.min-1

    Day 0 (on the day of embolization)

  • MRI perfusion parameters : Time to peak

    Measured in seconds

    7 - 14 days before embolization

  • MRI perfusion parameters : Time to peak

    Measured in seconds

    Day 0 (on the day of embolization)

  • Scanner perfusion parameters : Prostate iodine load at 80 s.

    Measured in mgI.mg of prostate-1

    7 - 14 days before embolization

  • MRI perfusion parameters : Prostate iodine load at 80 s.

    Measured in mgI.mg of prostate-1

    Day 0 (on the day of embolization)

Secondary Outcomes (15)

  • Influence of flow rate on the scanner algorithm

    1 - 15 days before embolization. Preliminary stage on phantom.

  • A. Correspondence between MRI and scanner: Capillary permeability

    1 - 7 days before embolization

  • A. Correspondence between MRI and scanner: Extracellular volume

    1 - 7 days before embolization

  • A. Correspondence between MRI and scanner: Blood volume

    1 - 7 days before embolization

  • A. Correspondence between MRI and scanner: Maximum slope

    1 - 7 days before embolization

  • +10 more secondary outcomes

Other Outcomes (7)

  • Age

    Day 0

  • Weight

    Day 0

  • Height

    Day 0

  • +4 more other outcomes

Study Arms (1)

Patients benefitting from a perfusion CT scan before embolization

EXPERIMENTAL

Prostatic perfusion parameters seem to be correlated with the effectiveness of embolization. Studying these prostatic perfusion parameters in perfusion CT and evaluating the prostatic Iodine load in dual energy CT will make it possible to better select responder patients.

Other: Perfusion CT scanning

Interventions

Perfusion CT scanningOTHER

Abdominopelvic CT scan with perfusion and spectral analysis performed 7 days (± 5 days) before prostate embolization.

Patients benefitting from a perfusion CT scan before embolization

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales only
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with symptomatic benign prostatic hypertrophy (prostate volume \> 50, IPSS \>7, QoL\>2) or patients catheterized after acute retention of urine with failed catheterization.
  • Creatinine clearance \> 30 mL/min for one of the two Cockcroft-Gault/MDRD equations)
  • Adult patients (≥18 years).
  • Patients with an indication for prostate embolization.
  • Patient with free and informed consent.
  • Patient who have signed the consent form.
  • Patient affiliated or beneficiary of a health insurance plan.

You may not qualify if:

  • Hypersensitivity to the active substance or to one of the excipients of the iodized contrast medium.
  • Severe renal impairment with renal function \<30mL/min.
  • Contraindication to prostate embolization (aorto-iliac bypass)
  • Patient participating in research defined as Category 1 Research Involving Human Subjects.
  • Patient under court protection, guardianship or curatorship.
  • Patient unable to give consent.
  • Patient for whom it is impossible to give informed information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nîmes University Hospital

Nîmes, Gard, 30029, France

Location

MeSH Terms

Conditions

Prostatic NeoplasmsAdenoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The infusion scans will be interpreted by a radiologist who does not know the patient's clinical result in order to avoid a classification bias.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2022

First Posted

May 25, 2022

Study Start

May 12, 2022

Primary Completion

January 19, 2024

Study Completion

January 19, 2024

Last Updated

March 10, 2025

Record last verified: 2025-03

Locations

FR(1)