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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02961686
Other study ID # 1635
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


Related Conditions & MeSH terms


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
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