Treatment Frequency and Satisfaction in Patients With Advanced Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01441713
First received: September 9, 2011
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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.


Condition
Prostatic Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Treatment Frequency and Satisfaction in Patients With Advanced Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • Preferred treatment/control frequency for patients with advanced prostate cancer [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

    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"



Secondary Outcome Measures:
  • Treatment satisfaction [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Treatment satisfaction ranging from "Very satisfied" til "Very unsatisfied" assessed by patient answers to the questionnaire

  • Side effects to treatment [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Side effects to treatment assessed by patient answers to the questionnaire

  • Treatment satisfaction, preferred frequency of clinical control, and side effects after surgical castration [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 178
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pharmaceutical group
Patients in pharmaceutical castration treatment for advanced prostate cancer
Surgical group
Patients having undergone surgical castration treatment for advanced prostate cancer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Men who are receiving pharmaceutical castration treatment (hormone treatment) at Herlev Hospital for advanced prostate cancer and men who have undergone surgical castration (Orchiectomy) and are in clinical control at Herlev Hospital.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441713

Locations
Denmark
Department of urology, Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
Principal Investigator: Mikkel Fode, MD Herlev Hospital, University of Copenhagen
  More Information

No publications provided

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01441713     History of Changes
Other Study ID Numbers: HeH.750.19-25
Study First Received: September 9, 2011
Last Updated: December 4, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Copenhagen University Hospital at Herlev:
Hormone treatment
castration
Orchiectomy
treatment frequency
treatment satisfaction
side effects

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 21, 2014