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Status unknownNCT04642833RENPROUpdated Dec 17, 2020

Prostate Cancer in Renal Transplants Recipients

An observational study in Prostate Cancer, Renal Transplantation and Kidney Transplant Recipients, sponsored by University of Florence. Status unknown at 1 site in Italy. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-12-17.

Sponsored by University of Florence · Observational

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
30
Ages
40 Years to 80 Years
Sex
Male
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Study summary

Kidney transplantation is considered the standard of care for patients with end-stage kidney disease under chronic dialysis treatment. Today, modern surgical techniques have dramatically improved the quality of life and the overall survival of renal transplant recipients (RTRs) . Besides, the use of novel immunosuppressors have increased the 1-year graft survival rate and decreased acute rejection rate . Unfortunately, several transplantation-related diseases including cancer, cardiovascular disease and infection may affect the survival of renal transplant recipients. It has been estimated that RTRs are 2- to 5- fold more likely to develop cancer compared to the general population. Therefore, the development of cancer has become a major concern as it is currently one of the main causes of death in RTRs. The increasing incidence of post-transplant malignancies is generally attributed to immunosuppression which leads to impaired immunosurveillance of cancer cells and virals infections capable of cancer development. Additionally, it has been observed a direct and specific pro-oncogenic effect on RTRs of immunosuppressive drugs and other immunosuppression-independent factors such as the increased age of RTRs, the male gender and the pre-transplant dialysis duration . Prostate cancer is the second most diagnosed cancer in men and the most common non-skin solid neoplasm in RTRs. Generally, the vast majority of post kidney transplantation prostate cancers are localised; however, due to the lack of randomized studies, no specific guidelines for the management of localized prostate cancer are available and, consequently, RTR patients are being treated with surgery or radiotherapy according to national or local guidelines. The concomitant use of immunosuppressors and the presence of the kidney graft in the pelvic cavity make the treatment of localised prostate cancer post kidney transplantation more challenging, highlighting the need for these patients to be addressed to urological oncology centres with surgeons familiar with oncological and transplant surgery.

Prostate cancer is the second most diagnosed cancer in men and the most common non-skin solid neoplasm in RTRs, however, little studies describe the real incidence of prostate cancer in RTRs.

The aim of this study is to retrospectively review a 25-year experience at the Florence Transplant Center in order to evaluate the incidence of prostate cancer and its possible clinical/pathological factors able to influence the survival.

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Conditions studied

  • Prostate Cancer
  • Renal Transplantation
  • Kidney Transplant Recipients

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 30 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University of Florence is the lead sponsor of 75 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients affected by prostate cancer after kidney transplantation

Inclusion criteria

  • Patient undergoing kidney transplantation in the period from July 1991 to September 2016
  • Development of prostate cancer confirmed histologically
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • Lack of clinical and prognostic data on selected patients
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
30 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. To investigate the incidence of prostate cancer in patients who underwent to renal transplantation from July 1991 to September 2016

    Time frame: 15 months

Secondary outcomes

  1. To retrospectively evaluate possible clinical/pathological factors able to influence the survival of prostate cancer in RTRs

    Time frame: 15 months

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Study locations

1 of 1 sites recruiting
  • University of Florence
    Florence, 50100, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04642833
Lead sponsor
University of Florence
Collaborators
Giandomenico Roviello, Pietro Spatafora, Graziano Vignolini, Sergio Serni, Simone Caroassai, Gabriella Nesi
Responsible party
Donata Villari (Researcher, University of Florence) — Principal investigator
First posted
Nov 24, 2020
Start date
Nov 18, 2020
Primary completion
Jan 18, 2021 (estimated)
Completion
Aug 2021 (estimated)
Last update
Dec 17, 2020

Study contacts

Donata Villari, MD
Contact
donata.villari@unifi.it
3387079707

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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