NCT02961686

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
2.7 years until next milestone

Study Start

First participant enrolled

July 16, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2019

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

Same day

First QC Date

November 9, 2016

Last Update Submit

July 19, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients with prostate cancer

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

Radiation: Patients affected by prostate cancer

Interventions

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

Patients with prostate cancer

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients affected by prostate cancer

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

Location

Study Officials

  • Ciro Franzese

    Istituto Clinico Humanitas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 9, 2016

First Posted

November 11, 2016

Study Start

July 16, 2019

Primary Completion

July 16, 2019

Study Completion

July 16, 2019

Last Updated

July 23, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations