E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060862 |
E.1.2 | Term | Prostate cancer |
|
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 |
Correlation of PTEN expression in biopsies from primary tumor and metastases with PSA response |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives: 1. Overall survival (OS) 2.Time to progression (TTP) 3. Objective response rate (RR) (RECIST) 4. Quality of life 5. Correlation of response with EGFR and pAkt expression 6. Toxicity 7. Correlation of PSA decline of at least 30% with PTEN loss 8. Correlation of clinical responses not qualifying for PR with PTEN loss |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histologically proven prostate cancer 2. PSA and/or clinical (including radiological) progression despite androgen deprivation (castration testosterone levels) (PSA progression:>=25% increase from baseline confirmed at least one week later) 3. Adequate antiadrogen withdrawal time (4 weeks for flutamide or nilutamide and 6 weeks for bicalutamide) 4. No prior chemotherapy 5. PSA at progression >=20 ng/ml 6. ECOG PS 0-2 7. Adequate bone marrow, renal and liver function (platelets ≥ 100.000/ul, white blood cells ≥ 3.000/ul or neutrophil count ≥ 1.500/ul,, creatinine ≤ 1.5 mg/dl, hepatic transaminases ≤ 2.5 x ULN, serum total bilirubin ≤ 1.5 x ULN) 8. Available archive material for PTEN screening or presence of lesions which could be biopsied (prostate, lymph nodes, liver, lung, soft tissue) 9. Signed written informed consent 10. Life expectancy >=3months 11. Age ≥ 18 years old |
|
E.4 | Principal exclusion criteria |
1. Less than 4 weeks from prior radiotherapy or radionuclide therapy 2. ECOG PS>2 3. Significant co-morbid disease, which prohibits the conduction of chemotherapy, such as active systemic infection, symptomatic cardiac or pulmonary disease, or psychiatric disorders |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary target variable will be PSA response in correlation with PTEN expression |
|
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |