Treatment Frequency and Satisfaction in Patients With Advanced Prostate Cancer

NCT01441713 | Completed

• 1 other identifier: HeH.750.19-25
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostatic Neoplasms

Keywords

Hormone treatment; castration; Orchiectomy; treatment frequency; treatment satisfaction; side effects

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Treatment satisfaction

  Up to 1 year

• Side effects to treatment

  Up to 1 year

• Treatment satisfaction, preferred frequency of clinical control, and side effects after surgical castration

  Up to 1 year

Study Arms (2)

Pharmaceutical group

Patients in pharmaceutical castration treatment for advanced prostate cancer

Surgical group

Patients having undergone surgical castration treatment for advanced prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• A diagnosis of advanced prostate cancer
• Receiving hormone manipulation treatment (pharmaceutical castration) OR having undergone surgical castration (orchiectomy)

You may not qualify if:

• Inability to read/write Danish

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead

Study Sites (1)

Department of urology, Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Mikkel Fode, MD

  Herlev Hospital, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2011
• First Posted: September 28, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 5, 2012

Record last verified: 2012-12

Locations

DK (1)