Quality of Life and Sexuality in Patients With Prostate Cancer

NCT ID: NCT02961686

Last Updated: 2019-07-23

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-16

Study Completion Date

2019-07-16

Brief Summary

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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

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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.

Conditions

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Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with prostate cancer

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

Patients affected by prostate cancer

Intervention Type RADIATION

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

Interventions

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Patients affected by prostate cancer

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

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Michele Tedeschi

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ciro Franzese

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

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Humanitas Research Hospital

Rozzano, Milan, Italy

Site Status

Countries

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Italy

Other Identifiers

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1635

Identifier Type: -

Identifier Source: org_study_id

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