Clinical trial NCT04642833: Prostate Cancer in Renal Transplants Recipients
Official title: Incidence and Clinical-pathological Characteristics of Prostate Cancer in Kidney Transplants Recipients ( KTRs)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Renal Transplantation
Kidney Transplant Recipients
Lead sponsor: University of Florence
Sponsor class: OTHER
Collaborators: name: Giandomenico Roviello
name: Pietro Spatafora
name: Graziano Vignolini
name: Sergio Serni
name: Simone Caroassai
name: Gabriella Nesi
First posted: 2020-11-24
Enrollment: 30
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by prostate cancer after kidney transplantation

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.


Eligibility criteria: 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

Primary outcomes:
measure: To investigate the incidence of prostate cancer in patients who underwent to renal transplantation from July 1991 to September 2016
timeFrame: 15 months
Secondary outcomes:
measure: To retrospectively evaluate possible clinical/pathological factors able to influence the survival of prostate cancer in RTRs
timeFrame: 15 months
Other outcomes:
Locations:
city: Florence
country: Italy
facility: University of Florence
Study officials:
References: