Adults with Traumatic Penile Severe DefectsPETRA-VCANCT06781606
Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts
A study testing Penile transplantation in people with Adults with Traumatic Penile Severe Defects and Congenital Penile Defects, run by Hospices Civils de Lyon at 9 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Adults with Traumatic Penile Severe Defects, Congenital Penile Defects, Micropenis
- What is being tested?
- Penile transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 9 sitesFrance
- Study dates
- 1 Jun 2025to 1 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites
Service d'urologie, andrologie et transplantation rénale Groupe hospitalier Pellegrin Tripode CHU Bordeaux
Bordeaux, 33000
Grégoire Capon, Doctor, +33 5 56 79 55 47, gregoire.capon@chu-bordeaux.fr
Ludovic Ferretti, Doctor
Service d'urologie, andrologie et transplantation rénale Hôpital Huriez CHRU Lille
Lille, 59037
François Marcelli, Doctor, +33 3 20 44 49 39, francois.marcelli@chru-lille.fr
François Marcelli, Doctor
Service d'urologie, chirurgie de la transplantation Hôpital Edouard Herriot Hospices Civils de Lyon
Lyon, 69003
Lionel Badet, Professor, +33 4 72 11 11 40, lionel.badet@chu-lyon.fr
Lionel Badet, Professor
Service de chirurgie urologique et transplantation rénale AP-HM Hôpital de la Conception
Marseille, 13005
Gilles Karsenty, Professor, +33 4 91 43 51 74, gilles.karsenty@ap-hm.fr
Gilles Karsenty, Professor
Service de chirurgie des brûlés, plastique, reconstructrice et esthétique Polyclinique Saint Roch
Montpellier, 34000
Antoine Faix, Doctor, +33 4 67 02 92 22
Antoine Faix, Doctor
Service néphrologie - soins intensifs - dialyse et transplantation CHU de Montpellier
Montpellier, 34295
Moglie Le Quintrec-Donnette, Professor, +33 4 67 33 84 79, m-lequintrec-donnette@chu-montpellier.fr
Moglie Le Quintrec-Donnette, Professor
Service d'urologie Hôpital Lyon Sud
Pierre-Bénite, 69310
Paul Neuville, Doctor, +33 4 72 67 88 37, paul.neuville@chu-lyon.fr
Paul Neuville, Doctor
Service d'urologie Hôpital Foch
Suresnes, 92151
François-Xavier Madec, Doctor, +33 1 46 25 25 25, f.madec@hopital-foch.com
François-Xavier Madec, Doctor
Département d'urologie, andrologie et transplantation rénale Hôpital Rangueil CHU de Toulouse
Toulouse, 31059
Eric Huygue, Professor, +33 5 61 32 31 06, huygue.e@chu-toulouse.fr
Eric Huygue, Professor
About this study
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.
- Being tested
- Penile transplantation
- Keywords
- Penile transplatation, Vascularized Composite Allografts, Allotransplantation, En bloc harvesting, urinary function, sexual function, self-image
- Medical subject headings
- Penis agenesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penile transplantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Penile transplantation | Experimental | Not described Receives: Procedure: Penile transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete functional evaluation
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®) );
Measured: 24 months
Complete functional evaluation
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)).
Measured: 24 months
Complete functional evaluation
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))
Measured: 24 months
Secondary outcomes (6)
Complete functional evaluation
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®) );
Measured: Preoperatively, 6 months and 12 months
Complete functional evaluation
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))
Measured: Preoperatively, 6 months and 12 months
Complete functional evaluation
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))
Measured: Preoperatively, 6 months and 12 months
Postoperative complications
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)
Measured: up to 60 months
Qualitive evaluation
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.
Measured: Preoperatively, 6 months, 12 months and 24 months
Health-economic evaluation
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults with Traumatic Penile Severe DefectsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multicentric, non-randomized, pilot study
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- French Association of Urology
- Responsible party
- Sponsor
- Investigators
- Paul Neuville, Doctor, Principal investigator, Service d'urologie Hôpital Lyon Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781606
- Sponsor's protocol ID
- 69HCL22_0906
- Other IDs
- 2024-A02180-47
- Acronym
- PETRA-VCA
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts
- ClinicalTrials.gov ID
- NCT06781606
- Acronym / sponsor ID
- PETRA-VCA / 69HCL22_0906
- Keywords
- Penile transplatation, Vascularized Composite Allografts, Allotransplantation, En bloc harvesting, urinary function, sexual function, self-image
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- French Association of Urology
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multicentric, non-randomized, pilot study
| Arm | Type | Receives |
|---|---|---|
| Penile transplantation | Experimental | Procedure: Penile transplantation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Penile transplantationThe 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. | Procedure or surgery | Penile transplantation |
Primary outcome
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®) );
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)).
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))
6 secondary outcomes
Complete functional evaluation
Time frame: Preoperatively, 6 months and 12 months
Complete functional evaluation
Time frame: Preoperatively, 6 months and 12 months
Complete functional evaluation
Time frame: Preoperatively, 6 months and 12 months
Postoperative complications
Time frame: up to 60 months
Qualitive evaluation
Time frame: Preoperatively, 6 months, 12 months and 24 months
Health-economic evaluation
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Neuville, Doctor principal investigator
Service d'urologie Hôpital Lyon Sud
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Penile transplantation in people with Adults with Traumatic Penile Severe Defects and Congenital Penile Defects, run by Hospices Civils de Lyon at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Neuville, Doctor (+33 4 72 67 88 37, paul.neuville@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete functional evaluation (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.