Quality of Life and Sexuality in Patients With Prostate Cancer

Quality of Life Clinical Trial

Official title:

Quality of Life and Sexuality in Patients Treated With Radical Radiotherapy for Prostate Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02961686
• Other study ID #: 1635
• Status: Withdrawn
• Start date: July 16, 2019
• Est. completion date: July 16, 2019

Study information

• Verified date: July 2019
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 16, 2019
• Est. primary completion date: July 16, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Quality of Life

Intervention

Radiation:
• Patients affected by prostate cancer
Patients affected by prostate cancer and treated with a multidisciplinary approach: it includes exclusive radiotherapy, psychological and andrologic evaluation.

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life measurement	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	2.5 years