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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
French Association of Urology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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