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

Prostate Cancer Clinical Trial

— EMBOPERF  

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05389202
• Other study ID #: NIMAO/2021-1/JF-01
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Julien FRANDON, Dr.
• Phone: +334 66 68 33 10
• Email: julien.frandon[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Prostate Cancer

Intervention

Other:
• Perfusion CT scanning
Abdominopelvic CT scan with perfusion and spectral analysis performed 7 days (± 5 days) before prostate embolization.

Locations

Country	Name	City	State
France	Nîmes University Hospital	Nîmes	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age	In years	Day 0
Other	Weight	In kilograms	Day 0
Other	Height	In centimeters	Day 0
Other	Comorbidities	All comorbidities such as cardiovascular condition, smoking etc., and diabetes will be recorded on the electronic patient file.	Day 0
Other	Adverse events	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.	Day 0
Other	Adverse events	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.	Day 7
Other	Adverse events	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.	Month 3
Primary	Catheterized patients: Removal of the urinary catheter at 3 months	Yes/No	Month 3
Primary	Non-catheterized patients: 25% decrease in the International Prostate Symptom Score	Yes/No	Month 3
Primary	Non-catheterized patients: one point improvement in the Global Quality of Life Score.	Yes/No	Month 3
Primary	MRI perfusion parameters : Capillary permeability	Measured in mL.mL tissue-1.min-1	7 - 14 days before embolization
Primary	Scanner perfusion parameters : Capillary permeability	Measured in mL.mL tissue-1.min-1	Day 0 (on the day of embolization)
Primary	MRI perfusion parameters : Extracellular volume	Measured in mL.mL tissue-1	7 - 14 days before embolization
Primary	Scanner perfusion parameters : Extracellular volume	Measured in mL.mL tissue-1	Day 0 (on the day of embolization)
Primary	MRI perfusion parameters : Blood volume	Measured in mL.mL tissue-1	7 - 14 days before embolization
Primary	Scanner perfusion parameters : Blood volume	Measured in mL.mL tissue-1	Day 0 (on the day of embolization)
Primary	MRI perfusion parameters : Maximum slope	Measured in ml.min-1	7 - 14 days before embolization
Primary	Scanner perfusion parameters : Maximum slope	Measured in ml.min-1	Day 0 (on the day of embolization)
Primary	MRI perfusion parameters : Time to peak	Measured in seconds	7 - 14 days before embolization
Primary	MRI perfusion parameters : Time to peak	Measured in seconds	Day 0 (on the day of embolization)
Primary	Scanner perfusion parameters : Prostate iodine load at 80 s.	Measured in mgI.mg of prostate-1	7 - 14 days before embolization
Primary	MRI perfusion parameters : Prostate iodine load at 80 s.	Measured in mgI.mg of prostate-1	Day 0 (on the day of embolization)
Secondary	Influence of flow rate on the scanner algorithm	The influence of flow rate on the scanner algorithm will be measured on the perfusion phantom model in mL.min-1.	1 - 15 days before embolization. Preliminary stage on phantom.
Secondary	A. Correspondence between MRI and scanner: Capillary permeability	Measured in mL.mL tissue-1.min-1	1 - 7 days before embolization
Secondary	A. Correspondence between MRI and scanner: Extracellular volume	Measured in mL.mL tissue-1	1 - 7 days before embolization
Secondary	A. Correspondence between MRI and scanner: Blood volume	Measured in mL.mL tissue-1	1 - 7 days before embolization
Secondary	A. Correspondence between MRI and scanner: Maximum slope	Measured in mL.min-1	1 - 7 days before embolization
Secondary	A. Correspondence between MRI and scanner: Time to peak	Measured in seconds	1 - 7 days before embolization
Secondary	A. Correspondence between MRI and scanner: 80-second iodine load	Measured in mgl.mg of prostate-1	1 - 7 days before embolization
Secondary	B. 4-D map Magnetic Resonance Imaging perfusion parameters : Volume of beads injected	Measured in mL	At the time of embolization
Secondary	B. Scanner perfusion parameters : Volume of beads injected	Measured in mL	At the time of embolization
Secondary	C. Influence of scanner acquisition parameters: kV	The influence of scanner acquisition parameters on the scanner algorithm will be measured on the the perfusion phantom model.	1 to 15 days before embolization. Preliminary stage on phantom.
Secondary	C. Influence of scanner acquisition parameters: mAs	The influence of scanner acquisition parameters on the scanner algorithm will be measured on the the perfusion phantom model.	1 to 15 days before embolization. Preliminary stage on phantom.
Secondary	C. Influence of scanner acquisition parameters: iterative reconstruction	The influence of scanner acquisition parameters on the scanner algorithm will be measured on the the perfusion phantom model.	1 to 15 days before embolization. Preliminary stage on phantom.
Secondary	C. Blood volume	The perfusion parameter "blood volume" will be measured on the phantom in mL	1 to 15 days before embolization. Preliminary stage on phantom.
Secondary	C. Maximum slope	The perfusion parameter "maximum slope" will be measured on the phantom in mL.min-1	1 to 15 days before embolization. Preliminary stage on phantom.
Secondary	C. Time to peak	The perfusion parameter "time to peak" will be measured on the phantom in seconds	1 to 15 days before embolization. Preliminary stage on phantom.