Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00919477

Acronym

CAMON

Enrollment

712

Registered

2009-06-12

Start date

2009-05-31

Completion date

2012-03-31

Last updated

2013-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate cancer, Casodex, Monotherapy

Brief summary

To gather information on the safety of monotherapy of Casodex® tablets 80 mg, targeting prostate cancer patients who have no history of having received treatment by either endocrine therapy (including surgical castration).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion criteria

* Prostate cancer patients who have no history of receiving endocrine therapy (including surgical castration), and who plan to undergo Casodex® tablets monotherapy for not less than 12 months

Design outcomes

Primary

Measure	Time frame
Adverse event incidence	Time since starting Casodex monotherapy, monthly

Secondary

Measure	Time frame
improvement of prostate cancer using Tumor marker PSA	Time since starting Casodex monotherapy, monthly
Maintenance of sexual function	At 3 months since starting Casodex monotherapy,

Countries

Japan

Outcome results