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NCT Number: NCT05389202

Study of Prostate Perfusion Before Embolization in Patients With Symptomatic Prostate Adenoma

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.

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Key information

Conditions

Prostate Cancer Adenoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Nîmes University Hospital

Nîmes, Gard, 30029, France

About this study

The hypothesis is that there are two types of prostate vascularization in patients with symptomatic prostate adenoma:

  • prostates mainly vascularized by large caliber prostate arteries with high flow, for which perfusion parameters in favor of hyper-perfusion will be found. In this case, prostate artery embolization will be effective;
  • prostates vascularized by a network of collaterals, with low flow-rates, for which perfusion parameters in favor of hypo-perfusion will be found. In this case, prostate artery embolization will not be very effective.

The purpose of this study is to investigate the association between prostate perfusion parameters (peak time, transit time, blood volume, capillary permeability) and the clinical efficacy of prostate embolization at 3 months. These perfusion parameters could become new biomarkers leading to better selection of patients eligible for efficient prostate embolization, in order to avoid a considerable treatment with no benefit for certain patients and thus limit their global exposure to X-rays during care.

Prior to this prospective study on patients with symptomatic benign prostate hypertrophy, a preliminary experimental study will be performed on a perfusion phantom in order to better understand the differences in the calculation of perfusion parameters according to the three main algorithms used. This will lead to optimization of the prostate perfusion protocol for the scanner: computed tomography acquisition parameters (kilovoltage, Milliamps per second) and therefore the X-ray dose delivered to patients, sampling frequency, and model to be used. The first results of this study have already led to modifications in scanner perfusion acquisition protocols for the initiation of clinical study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 in an exclusion period as determined by another study.
  • Patient under court protection, guardianship or curatorship.
  • Patient unable to give consent.
  • Patient for whom it is impossible to give informed information.

Treatment and study plan

Perfusion CT scanning

Other

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

Primary outcomes

  1. Catheterized patients: Removal of the urinary catheter at 3 months

    Time frame: Month 3

    Yes/No

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

    Time frame: Month 3

    Yes/No

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

    Time frame: Month 3

    Yes/No

  4. MRI perfusion parameters : Capillary permeability

    Time frame: 7 - 14 days before embolization

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

  5. Scanner perfusion parameters : Capillary permeability

    Time frame: Day 0 (on the day of embolization)

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

  6. MRI perfusion parameters : Extracellular volume

    Time frame: 7 - 14 days before embolization

    Measured in mL.mL tissue-1

  7. Scanner perfusion parameters : Extracellular volume

    Time frame: Day 0 (on the day of embolization)

    Measured in mL.mL tissue-1

  8. MRI perfusion parameters : Blood volume

    Time frame: 7 - 14 days before embolization

    Measured in mL.mL tissue-1

  9. Scanner perfusion parameters : Blood volume

    Time frame: Day 0 (on the day of embolization)

    Measured in mL.mL tissue-1

  10. MRI perfusion parameters : Maximum slope

    Time frame: 7 - 14 days before embolization

    Measured in ml.min-1

  11. Scanner perfusion parameters : Maximum slope

    Time frame: Day 0 (on the day of embolization)

    Measured in ml.min-1

  12. MRI perfusion parameters : Time to peak

    Time frame: 7 - 14 days before embolization

    Measured in seconds

  13. MRI perfusion parameters : Time to peak

    Time frame: Day 0 (on the day of embolization)

    Measured in seconds

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

    Time frame: 7 - 14 days before embolization

    Measured in mgI.mg of prostate-1

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

    Time frame: Day 0 (on the day of embolization)

    Measured in mgI.mg of prostate-1

Secondary outcomes

  1. Influence of flow rate on the scanner algorithm

    Time frame: 1 - 15 days before embolization. Preliminary stage on phantom.

    The influence of flow rate on the scanner algorithm will be measured on the perfusion phantom model in mL.min-1.

  2. A. Correspondence between MRI and scanner: Capillary permeability

    Time frame: 1 - 7 days before embolization

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

  3. A. Correspondence between MRI and scanner: Extracellular volume

    Time frame: 1 - 7 days before embolization

    Measured in mL.mL tissue-1

  4. A. Correspondence between MRI and scanner: Blood volume

    Time frame: 1 - 7 days before embolization

    Measured in mL.mL tissue-1

  5. A. Correspondence between MRI and scanner: Maximum slope

    Time frame: 1 - 7 days before embolization

    Measured in mL.min-1

  6. A. Correspondence between MRI and scanner: Time to peak

    Time frame: 1 - 7 days before embolization

    Measured in seconds

  7. A. Correspondence between MRI and scanner: 80-second iodine load

    Time frame: 1 - 7 days before embolization

    Measured in mgl.mg of prostate-1

  8. B. 4-D map Magnetic Resonance Imaging perfusion parameters : Volume of beads injected

    Time frame: At the time of embolization

    Measured in mL

  9. B. Scanner perfusion parameters : Volume of beads injected

    Time frame: At the time of embolization

    Measured in mL

  10. C. Influence of scanner acquisition parameters: kV

    Time frame: 1 to 15 days before embolization. Preliminary stage on phantom.

    The influence of scanner acquisition parameters on the scanner algorithm will be measured on the the perfusion phantom model.

  11. C. Influence of scanner acquisition parameters: mAs

    Time frame: 1 to 15 days before embolization. Preliminary stage on phantom.

    The influence of scanner acquisition parameters on the scanner algorithm will be measured on the the perfusion phantom model.

  12. C. Influence of scanner acquisition parameters: iterative reconstruction

    Time frame: 1 to 15 days before embolization. Preliminary stage on phantom.

    The influence of scanner acquisition parameters on the scanner algorithm will be measured on the the perfusion phantom model.

  13. C. Blood volume

    Time frame: 1 to 15 days before embolization. Preliminary stage on phantom.

    The perfusion parameter "blood volume" will be measured on the phantom in mL

  14. C. Maximum slope

    Time frame: 1 to 15 days before embolization. Preliminary stage on phantom.

    The perfusion parameter "maximum slope" will be measured on the phantom in mL.min-1

  15. C. Time to peak

    Time frame: 1 to 15 days before embolization. Preliminary stage on phantom.

    The perfusion parameter "time to peak" will be measured on the phantom in seconds

Other outcomes

  1. Age

    Time frame: Day 0

    In years

  2. Weight

    Time frame: Day 0

    In kilograms

  3. Height

    Time frame: Day 0

    In centimeters

  4. Comorbidities

    Time frame: Day 0

    All comorbidities such as cardiovascular condition, smoking etc., and diabetes will be recorded on the electronic patient file.

  5. Adverse events

    Time frame: Day 0

    Any adverse events will be recorded: Allergy to contrast medium, urinary tract sepsis, persistent urinary tract infection, dysuria, severe hematuria, hemospermia, bladder ulceration/necrosis, rectal ulcer, rectal bleeding, severe radiation skin injury, acute urinary retention, pelvic-perineal pain, acute urinary retention, prostatitis, orchi-epididymitis, obstructive renal failure, chronic bladder retention, lithiasis, hypocontractile bladder. Puncture site hematoma, artery dissection/vessel injury (dissection, perforation, rupture, occlusion, spasm), false aneurysm requiring intervention, arteriovenous fistula requiring intervention, angioplasty or stenting, hematoma/bleeding requiring transfusion or surgery, arterial embolism/thrombosis, need for revascularization by bypass surgery, infection. Due to dual-energy CT with contrast injection: stochastic risk of X-ray exposure; risks related to non-ionic contrast injection: intolerance, nausea, vomiting, urticaria, anaphylactic shock.

  6. Adverse events

    Time frame: Day 7

    Any adverse events will be recorded: Allergy to contrast medium, urinary tract sepsis, persistent urinary tract infection, dysuria, severe hematuria, hemospermia, bladder ulceration/necrosis, rectal ulcer, rectal bleeding, severe radiation skin injury, acute urinary retention, pelvic-perineal pain, acute urinary retention, prostatitis, orchi-epididymitis, obstructive renal failure, chronic bladder retention, lithiasis, hypocontractile bladder. Puncture site hematoma, artery dissection/vessel injury (dissection, perforation, rupture, occlusion, spasm), false aneurysm requiring intervention, arteriovenous fistula requiring intervention, angioplasty or stenting, hematoma/bleeding requiring transfusion or surgery, arterial embolism/thrombosis, need for revascularization by bypass surgery, infection. Due to dual-energy CT with contrast injection: stochastic risk of X-ray exposure; risks related to non-ionic contrast injection: intolerance, nausea, vomiting, urticaria, anaphylactic shock.

  7. Adverse events

    Time frame: Month 3

    Any adverse events will be recorded: Allergy to contrast medium, urinary tract sepsis, persistent urinary tract infection, dysuria, severe hematuria, hemospermia, bladder ulceration/necrosis, rectal ulcer, rectal bleeding, severe radiation skin injury, acute urinary retention, pelvic-perineal pain, acute urinary retention, prostatitis, orchi-epididymitis, obstructive renal failure, chronic bladder retention, lithiasis, hypocontractile bladder. Puncture site hematoma, artery dissection/vessel injury (dissection, perforation, rupture, occlusion, spasm), false aneurysm requiring intervention, arteriovenous fistula requiring intervention, angioplasty or stenting, hematoma/bleeding requiring transfusion or surgery, arterial embolism/thrombosis, need for revascularization by bypass surgery, infection. Due to dual-energy CT with contrast injection: stochastic risk of X-ray exposure; risks related to non-ionic contrast injection: intolerance, nausea, vomiting, urticaria, anaphylactic shock.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Study of Prostate Perfusion Before Embolization in Patients With Symptomatic Prostate Adenoma. A Single-center Prospective Cohort Pilot Study to Determine the Predictive Factors of Clinical Efficacy Associated With a Prior Phantom Study.

Acronym: EMBOPERF

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 25, 2022
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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