E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic Hormone-Refractory Prostate Cancer |
Trattamento del Carcinoma Prostatico Metastatico Ormono-refrattario |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036909 |
E.1.2 | Term | Prostate cancer metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 |
The primary objective of this study is to compare the duration of survival between the two treatment arms. |
L'obiettivo primario di questo studio e' quello di confrontare la sopravvivenza tra i due bracci di trattamento. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives are to compare between treatment arms: Time to radiologic disease progression Time to pain progression |
Gli obiettivi secondari sono di confrontare i due bracci di trattamento in relazione a:- Il tempo fino alla progressione radiologica di malattia
- Il tempo fino alla progressione del dolore |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate Males greater than 18 years of age Patients taking any Level 3 pain medication at any dose with any frequency. Patients taking Level 2 pain medication for cancer related pain, confirmed by investigator assessment. In order to assess the source of pain and the pain medication level (see Appendix E), the investigator should review the patient s completed assessment(s) of pain, perform a complete medical history, including current medications and physical examination, and review results from bone and CT scans. Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy (after discontinuation of anti-androgen therapy) as determined by one of the following: Progressive measurable disease on CT scan or MRI as assessed using un-modified RECIST guidelines. Progressive non-measurable disease as defined by the appearance of one or more new lesions on bone scan. PSA progression, as defined by two consecutive rising PSA values obtained at least 2 weeks apart, and both obtained at least 4 weeks after discontinuation of any other antiandrogen therapy. The second PSA value must be 5.0 ng/mL Detectable metastases by bone scan, CT scan or MRI. Testosterone < 50 ng/dL (1.73 nmol/L). Must have had orchiectomy or is currently receiving an LHRH agonist/antagonist WBC > 3,000 cells/mm3, ANC > 1,500 cells/mm3, hemoglobin > 9 g/dL (5.6 mmol/L), and platelets > 100,000 cells/mm3 Serum creatinine < 2.0 mg/dL (177 µmol/L) Total or direct bilirubin < the upper limit of normal AST or ALT 1.5 times the upper limit of normal concomitant with alkaline phosphatase 2.5 times the upper limit of normal CD4+ lymphocytes > 200 cells/mm3 ECOG performance status 2 (performance status of 3 is allowed if due to bone pain) Life expectancy of at least 6 months If sexually active, willing to use barrier contraception during study drug treatment The ability to understand and the willingness to sign a written informed consent |
Questo studio prevede l'arruolamento di circa 600 pazienti
eleggibili affetti da carcinoma prostatico refrattario alla terapia ormonale e associato a dolore che necessita di una terapia con analgesici narcotici. I pazienti non devono mai aver assunto Taxano in precedenza e non devono essere stati sottoposti a piu' di un trattamento chemioterapico sistemico. I pazienti eleggibili dovranno avere uno stato di validita' ECOG  2 (e' ammesso uno stato di validita' pari a 3 se dovuto al dolore osseo) e metastasi rilevabili alla scintigrafia ossea, alla TAC o alla RMN. Vengono inclusi nello studio tutti i pazienti che assumono una qualsiasi terapia antalgica per dolore di livello 3 a qualsiasi dosaggio e a con qualsiasi frequenza. Vengono considerati eleggibili per lo studio i pazienti che assumono una terapia antalgica per dolore di livello 2 correlato al carcinoma, se confermato da valutazione dello sperimentatore. |
|
E.4 | Principal exclusion criteria |
Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer Clinical evidence of brain metastases or history of brain metastases Third space fluid accumulation, such as ascites or symptomatic pleural effusion Clinically significant active infection or uncontrolled medical condition considered high-risk for docetaxel, corticosteroids or investigational new drug treatment Prior gene therapy or cancer vaccine for prostate cancer More than one prior systemic chemotherapy regimen, or any taxane chemotherapy. Patients must have completed chemotherapy at least 4 weeks prior to randomization and have recovered from all side effects. |
Metastasi cerebrali, ascite, infezioni attive, piu' di un regime chemioterapico sistemico o terapia con Taxano/radioterapia/intervento chirurgico (entro 4 settimane prima della randomizzazione) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is duration of survival. |
L'endpoint primario e' la durata della sopravvivenza |
|
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 42 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 42 |
E.8.9.2 | In all countries concerned by the trial days | 0 |