Prostate Cancer in Renal Transplants Recipients

NCT04642833 | Unknown

• 1 other identifier: DVillari
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Renal Transplantation; Kidney Transplant Recipients

Outcome Measures

Primary Outcomes (1)

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

  15 months

Secondary Outcomes (1)

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

  15 months

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by prostate cancer after kidney transplantation

You may qualify if:

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

You may not qualify if:

• Lack of clinical and prognostic data on selected patients

Sponsors & Collaborators

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

Study Sites (1)

University of Florence

Florence, 50100, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Donata Villari, MD

CONTACT

3387079707; donata.villari@unifi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 24, 2020
• Study Start: November 18, 2020
• Primary Completion: January 18, 2021
• Study Completion: August 1, 2021
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

IT (1)