Quality of Life and Sexuality in Patients With Prostate Cancer

Withdrawn

• Conditions: Quality of Life
• Interventions: Radiation: Patients affected by prostate cancer

• Registration Number: NCT02961686
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

The trial is to describe quality of life in patients affected by prostate cancer treated with exclusive radiotherapy and submitted to psychological and andrologic evaluation.

Detailed Description

This trial is to describe quality of life and sexuality in patients with prostate cancer treated with exclusive radiotherapy. Descriptive analysis of baseline characteristics will be performed by using appropriate summary measures for continous and categorical data. Analysis of variation over time of FACT scores will be conducted by means of ANOVA analysis for repeated measures.

Study Timeline

• Study First Submitted: 2016-11-09
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-11
• Status Verified: 2019-07
• Study Start: 2019-07-16
• Primary Completion: 2019-07-16
• Study Completion: 2019-07-16
• Last Update Submitted: 2019-07-19
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• Age 18-75 years.
• Histologically-proven of prostate cancer
• Indication to radical radiotherapy on prostate/ prostate + seminal vesicles / prostate + seminal vesicles + pelvic lymph nodes
• Informed consent

Exclusion Criteria

• Other coexisting malignancies, uncontrolled intercurrent illness, active infectious processes, and exudative, bloody, or cytologically malignant effusions excluded patients from the trial.
• Previous surgery for prostate cancer, severe cardiac or vascular pathology
• Other major surgery in the preceding year or currently undergoing psychiatric care or psychological counseling.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with prostate cancer	Patients affected by prostate cancer	Patients affected by prostate cancer and treated with a multidisciplinary approach that comprise exclusive radiotherapy, psychological and andrologic evaluation.

Primary Outcome Measures

Name	Time	Method
Quality of life measurement	2.5 years	Evaluation of the quality of life with FACT-P test in patient affected by prostate cancer treated with exclusive radiotherapy and submitted to psychological and andrologic evaluation

Trial Locations

Locations (1)

Humanitas Research Hospital; 🇮🇹 Rozzano, Milan, Italy