RENPRO: Prostate Cancer in Renal Transplants Recipients

Sponsor
University of Florence (Other)
Overall Status
Recruiting
CT.gov ID
NCT04642833
Collaborator
Giandomenico Roviello (Other), Pietro Spatafora (Other), Graziano Vignolini (Other), Sergio Serni (Other), Simone Caroassai (Other), Gabriella Nesi (Other)
30
1
8.4
3.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Incidence and Clinical-pathological Characteristics of Prostate Cancer in Kidney Transplants Recipients ( KTRs)
    Actual Study Start Date :
    Nov 18, 2020
    Anticipated Primary Completion Date :
    Jan 18, 2021
    Anticipated Study Completion Date :
    Aug 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. To investigate the incidence of prostate cancer in patients who underwent to renal transplantation from July 1991 to September 2016 [15 months]

    Secondary Outcome Measures

    1. To retrospectively evaluate possible clinical/pathological factors able to influence the survival of prostate cancer in RTRs [15 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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:

    • Lack of clinical and prognostic data on selected patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Florence Florence Italy 50100

    Sponsors and Collaborators

    • University of Florence
    • Giandomenico Roviello
    • Pietro Spatafora
    • Graziano Vignolini
    • Sergio Serni
    • Simone Caroassai
    • Gabriella Nesi

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Donata Villari, Researcher, University of Florence
    ClinicalTrials.gov Identifier:
    NCT04642833
    Other Study ID Numbers:
    • DVillari
    First Posted:
    Nov 24, 2020
    Last Update Posted:
    Dec 17, 2020
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 17, 2020