Androgen-Independent Prostate Cancer
Conditions
Interventions
Trade Name: Digitoxin
Product Name: Digitoxin
Pharmaceutical Form: Tablet
Other descriptive name: Digitoxin
Concentration unit: mg milligram(s)
Sponsors
Division K Kärnsjukhuset
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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 Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A. The proportion of complete or partial responders as determined by S-PSA assessments, i.e. response rate: That proportion of patients who responded to treatment with complete response (CR) or partial response (PR). B. Survival; time to death: from date of registration to date of death due to any cause.;Secondary Objective: Time to progression; from date of registration to date of first observation of progressive disease.;Primary end point(s): The primary endpoint is the proportion of complete or partial responders as determined by repeated S-PSA assessments. | — |
Countries
Sweden
Outcome results
None listed