Treatment Frequency and Satisfaction in Patients With Advanced Prostate Cancer

Prostatic Neoplasms Clinical Trial

Official title:

Treatment Frequency and Satisfaction in Patients With Advanced Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01441713
• Other study ID #: HeH.750.19-25
• Status: Completed
• Phase: N/A
• First received: September 9, 2011
• Last updated: December 4, 2012
• Start date: September 2011
• Est. completion date: June 2012

Study information

• Verified date: December 2012
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

Patients with advanced prostate cancer usually receive some kind of pharmaceutical castration or undergo surgical castration. At the investigators department the pharmaceutical treatment is most often given with a 3 month interval.

Over the last few years new drugs, which allow for lees frequent treatment, have been developed. The purpose of this study is to assess how the treatment affects patients and if our current patients would prefer to receive treatment at different intervals than they do at the present time. At the same time the investigators will assess how surgical treatment affects our patients. This will be assessed by patient questionnaires administered at our clinic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A diagnosis of advanced prostate cancer

• Receiving hormone manipulation treatment (pharmaceutical castration) OR having undergone surgical castration (orchiectomy)

Exclusion Criteria:

• Inability to read/write Danish

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Prostatic Neoplasms

Locations

Country	Name	City	State
Denmark	Department of urology, Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preferred treatment/control frequency for patients with advanced prostate cancer	Preferred treatment frequency is assessed by patient answers to the question: "If treatments were equally effective from a medical standpoint - How often would you then prefer to receive treatment"	Up to 1 year	No
Secondary	Treatment satisfaction	Treatment satisfaction ranging from "Very satisfied" til "Very unsatisfied" assessed by patient answers to the questionnaire	Up to 1 year	No
Secondary	Side effects to treatment	Side effects to treatment assessed by patient answers to the questionnaire	Up to 1 year	No
Secondary	Treatment satisfaction, preferred frequency of clinical control, and side effects after surgical castration	As a secondary endpoint the investigators will look at answers to satisfaction, wishes for control visits and side effects in the group of patients who received surgical castration for their advanced prostate cancer.	Up to 1 year	No