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Prostate Cancer in Renal Transplants Recipients

NCT ID: NCT04642833

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-18

Study Completion Date

2021-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer Renal Transplantation Kidney Transplant Recipients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Giandomenico Roviello

UNKNOWN

Sponsor Role collaborator

Pietro Spatafora

UNKNOWN

Sponsor Role collaborator

Graziano Vignolini

UNKNOWN

Sponsor Role collaborator

Sergio Serni

UNKNOWN

Sponsor Role collaborator

Simone Caroassai

UNKNOWN

Sponsor Role collaborator

Gabriella Nesi

UNKNOWN

Sponsor Role collaborator

University of Florence

OTHER

Sponsor Role lead

Responsible Party

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Donata Villari

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Florence

Florence, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Donata Villari, MD

Role: CONTACT

Phone: 3387079707

Email: [email protected]

Facility Contacts

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Donata Villari

Role: primary

Other Identifiers

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DVillari

Identifier Type: -

Identifier Source: org_study_id