We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment Frequency and Satisfaction in Patients With Advanced Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01441713
First Posted: September 28, 2011
Last Update Posted: December 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
  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 ]

    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01441713     History of Changes
Other Study ID Numbers: HeH.750.19-25
First Submitted: September 9, 2011
First Posted: September 28, 2011
Last Update Posted: December 5, 2012
Last Verified: December 2012

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

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