A pilot phase II study of digitoxin for Androgen-Independent Prostate Cancer (AIPC)

Division K Kärnsjukhuset0 sites30 target enrollmentNovember 9, 2006

Overview

No summary available.

Registry

who.int

Start Date

November 9, 2006

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

Division K Kärnsjukhuset

•1\. Age 40\-80 years.
•2\. Life expectancy greater than 3 months.
•3\. Histologically proven carcinoma of the prostate (any T or N category) with evidence of progression following primary hormonal treatment, i.e. hormone resistant.
•4\. S\-PSA level at trial entry should be greater than or equal to 5 ng/ml. S\-PSA progression should be documented by two consecutive increases in S\-PSA before enrollment. Each increase in S\-PSA should be at least one unit and it should be at least 4 weeks between the samples.
•5\. The patient has WHO performance status 0\-2, for definition see Appendix.
•6\. Patient is receiving hormone therapy (i.e. an LHRH agonist and/or anti\-androgen) and/or orchiectomy has been performed. Ongoing endocrine treatment should continue.
•7\. Patients must be physically, mentally and emotionally able to give informed consent.
•8\. Signed informed consent has been given.
•9\. Prior radiation therapy will be allowed, but radiotherapy during the study is not allowed. No concurrent other chemotherapy is allowed in the study. Another malignancy is allowed if no other chemotherapy drug is given.
•Are the trial subjects under 18? no

•1\. The patient has a relevant concurrent disease or baseline laboratory results, which put the patient at risk to take digitoxin.
•2\. Patients with heart disease already on a cardiac glycoside are not eligible.