Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts (PETRA-VCA)

January 13, 2025 updated by: Hospices Civils de Lyon
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France, 33000
        • Service d'urologie, andrologie et transplantation rénale Groupe hospitalier Pellegrin Tripode CHU Bordeaux
        • Contact:
        • Contact:
          • Ludovic Ferretti, Doctor
        • Contact:
          • Grégoire Capon, Doctor
      • Lille, France, 59037
        • Service d'urologie, andrologie et transplantation rénale Hôpital Huriez CHRU Lille
        • Contact:
        • Contact:
          • François Marcelli, Doctor
      • Lyon, France, 69003
        • Service d'urologie, chirurgie de la transplantation Hôpital Edouard Herriot Hospices Civils de Lyon
        • Contact:
        • Contact:
          • Lionel Badet, Professor
      • Marseille, France, 13005
        • Service de chirurgie urologique et transplantation rénale AP-HM Hôpital de la Conception
        • Contact:
        • Contact:
          • Gilles Karsenty, Professor
        • Contact:
          • Valérie Moal, Professor
      • Montpellier, France, 34000
        • Service de chirurgie des brûlés, plastique, reconstructrice et esthétique Polyclinique Saint Roch
        • Contact:
          • Antoine Faix, Doctor
          • Phone Number: +33 4 67 02 92 22
        • Contact:
          • Antoine Faix, Doctor
      • Montpellier, France, 34295
        • Service néphrologie - soins intensifs - dialyse et transplantation CHU de Montpellier
        • Contact:
        • Contact:
          • Moglie Le Quintrec-Donnette, Professor
      • Pierre-Bénite, France, 69310
        • Service d'urologie Hôpital Lyon Sud
        • Contact:
        • Contact:
          • Paul Neuville, Doctor
      • Suresnes, France, 92151
        • Service d'urologie Hôpital Foch
        • Contact:
        • Contact:
          • François-Xavier Madec, Doctor
      • Toulouse, France, 31059
        • Département d'urologie, andrologie et transplantation rénale Hôpital Rangueil CHU de Toulouse
        • Contact:
        • Contact:
          • Eric Huygue, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Penile transplantation
Procedure: Penile transplantation
The penile transplantation will take place at the Edouard Herriot hospital, part of the Hospices Civils de Lyon. It will be carried out on the same day or the day after the harvesting depending on the timing of the harvesting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete functional evaluation
Time Frame: 24 months
Complete functional evaluation after penile transplantation, including the different function of the phallus : Urinary function (uroflowmetry, post-voiding residual voluma and Urinary Symptom Profile (USP®) );
24 months
Complete functional evaluation
Time Frame: 24 months
Complete functional evaluation after penile transplantation, including the different function of the phallus : sexual function (penile doppler ultrasonography, nocturnal penile tumescence, Erection Hardness Score (EHS) and the International Index of Erectile Function (IIEF)).
24 months
Complete functional evaluation
Time Frame: 24 months
Complete functional evaluation after penile transplantation, including the different function of the phallus : aesthetics and self-image (Rosenberg scale, Male Genital Self-image Scale (MGSIS), Self Esteem and Relationship questionnaire (SEAR))
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete functional evaluation
Time Frame: Preoperatively, 6 months and 12 months
Complete functional evaluation after penile transplantation, including the different function of the phallus : Urinary function (uroflowmetry, post-voiding residual voluma and Urinary Symptom Profile (USP®) );
Preoperatively, 6 months and 12 months
Complete functional evaluation
Time Frame: Preoperatively, 6 months and 12 months
Complete functional evaluation after penile transplantation, including the different function of the phallus : sexual function (penile doppler ultrasonography, nocturnal penile tumescence, Erection Hardness Score (EHS) and the International Index of Erectile Function (IIEF))
Preoperatively, 6 months and 12 months
Complete functional evaluation
Time Frame: Preoperatively, 6 months and 12 months
Complete functional evaluation after penile transplantation, including the different function of the phallus : aesthetics and self-image (Rosenberg scale, Male Genital Self-Image Scale (MGSIS), Self Esteem and Relationship questionnaire (SEAR))
Preoperatively, 6 months and 12 months
Postoperative complications
Time Frame: up to 60 months
Any surgical complications which occur in the first three months post transplantation will be collected , they will be assessed according to their cause and level of severity (Clavien-Dindo Classification). Infectious and metabolic complications, side effects of immunosuppression including renal function, New Onset Diabetes After Transplantation (NODAT), infection, incidence of post-transplant malignancy will be collected throughout the study from blood tests and ECBU. Acute organ rejection evaluation will be evaluated by allograft biopsy (lymphocytic infiltrate, apoptosis, artery endothelialitis)
up to 60 months
Qualitive evaluation
Time Frame: Preoperatively, 6 months, 12 months and 24 months
Semi-structured patient interviews will be performed. The preoperative interview will investigate the functional aspects of urination and sexuality when suffering from penile defect. A specific interest will be given to the expectations of the patient and foreseen benefit of PT. The appropriation and the experience of allotransplantation will be explored along with the different functionnal domains.
Preoperatively, 6 months, 12 months and 24 months
Health-economic evaluation
Time Frame: 24 months
The cost per penile transplantation procedure including transplant preparation will be estimated from the hospital perspective. Moreover the quantity of resources consumed and the total penile transplantation cost per patient including post-transplantation cost follow-up cost will be assessed from the health care system perspective.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Collaborators

French Association of Urology

Investigators

  • Principal Investigator: Paul Neuville, Doctor, Service d'urologie Hôpital Lyon Sud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2031

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69HCL22_0906
  • 2024-A02180-47 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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