E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Androgen-Independent Prostate Cancer |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
Time to progression; from date of registration to date of first observation of progressive disease. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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.
|
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the proportion of complete or partial responders as determined by repeated S-PSA assessments. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
a pilot phase II, non-randomized, single-arm study |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |