Clinical trial NCT06781606: Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts
Official title: Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adults with Traumatic Penile Severe Defects
Congenital Penile Defects
Micropenis
Keywords: Penile transplatation
Vascularized Composite Allografts
Allotransplantation
En bloc harvesting
urinary function
sexual function
self-image
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: French Association of Urology
First posted: 2025-01-17
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multicentric, non-randomized, pilot study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Penile transplantation (PT) has recently emerged as an option for penile reconstruction and has shown encouraging outcomes at the international level with two ongoing PT program (US, South Africa). Emergence of such option has been possible thanks to the development of vascularized composite allotransplantation and because of the important limitations of autologous reconstruction (phalloplasty). Feasibility has already been proven, but the surgical management remains in its infancy and has never been tested at a European level. Furthermore, the balance between functional improvement and immunosuppressive risk still needs to be enlightened.


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years and ≤ 60 years
* Patient with traumatic penile severe defects (amputation), or congenital penile defects (micropenis)
* ASA ≤ 2
* NYHA ≤ 1
* Creatinine clearance \> 60 mL/min (CKD-EPI)
* Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
* Informed consent signed to participate to the study

Exclusion Criteria:

* Gender incongruence
* Congenital penile defects resulting from exstrophy/epispadias
* Penile malformation due to selh-half/self-amputation
* Amputation for penile cancer
* Other types of malignancy in remission for less than 5 years
* Progressive malignant tumor
* Presenting hepatitis B, hepatitis C, or HIV infection not controlled by appropriate anti-viral therapy
* Uncontrolled arterial hypertension
* Moderate renal failure : glomerular filtration rate of less than 60 mL/min per 1.73 m2
* EBV sero-negative recipient with EBV sero-positive graft, due to the risk of lymphoma
* Non controlled chronic infection
* Malignancy, Connective tissue disease
* Amyloidosis
* Unbalanced diabetes
* Patient with a contraindication to performing an MRI examination
* Contra-indication of Thymoglobuline: Hypersensitivity to rabbit proteins or to any of the excipients of Thymoglobuline, acute or chronic infections that contraindicate any additional immunosuppression,
* Contra-inducation of tacrolimus: Hypersensitivity to tacrolimus or others macrolides, or any of the excipients of PROGRAF,
* Contra-indication of Mycophenolate mofetil: in patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or any of the excipients, Hypersensitivity reactions to mycophenolate mofetil;
* History of major psychiatric disorders \< 3 years (psychotic disorders, severe substance abuse, severe personality disorders) or persons under psychiatric care ;
* Person deprived of their liberty by a judicial or administrative decision ;
* Person admitted to a health or social institution for purposes other than research
* Adult subjects to a legal protection measure (guardianship, curatorship)
* Person not affiliated to a social security scheme of beneficiaries of a similar scheme

Primary outcomes:
measure: Complete functional evaluation
timeFrame: 24 months
measure: Complete functional evaluation
timeFrame: 24 months
measure: Complete functional evaluation
timeFrame: 24 months
Secondary outcomes:
measure: Complete functional evaluation
timeFrame: Preoperatively, 6 months and 12 months
measure: Complete functional evaluation
timeFrame: Preoperatively, 6 months and 12 months
measure: Complete functional evaluation
timeFrame: Preoperatively, 6 months and 12 months
measure: Postoperative complications
timeFrame: up to 60 months
measure: Qualitive evaluation
timeFrame: Preoperatively, 6 months, 12 months and 24 months
measure: Health-economic evaluation
timeFrame: 24 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service d'urologie, andrologie et transplantation rénale Groupe hospitalier Pellegrin Tripode CHU Bordeaux
city: Lille
country: France
facility: Service d'urologie, andrologie et transplantation rénale Hôpital Huriez CHRU Lille
city: Lyon
country: France
facility: Service d'urologie, chirurgie de la transplantation Hôpital Edouard Herriot Hospices Civils de Lyon
city: Marseille
country: France
facility: Service de chirurgie urologique et transplantation rénale AP-HM Hôpital de la Conception
city: Montpellier
country: France
facility: Service de chirurgie des brûlés, plastique, reconstructrice et esthétique Polyclinique Saint Roch
city: Montpellier
country: France
facility: Service néphrologie - soins intensifs - dialyse et transplantation CHU de Montpellier
city: Pierre-Bénite
country: France
facility: Service d'urologie Hôpital Lyon Sud
city: Suresnes
country: France
facility: Service d'urologie Hôpital Foch
city: Toulouse
country: France
facility: Département d'urologie, andrologie et transplantation rénale Hôpital Rangueil CHU de Toulouse
Study officials:
affiliation: Service d'urologie Hôpital Lyon Sud
name: Paul Neuville, Doctor
role: PRINCIPAL_INVESTIGATOR
References: