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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003811-23 | EudraCT Number |
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| Name | Class |
|---|---|
| Janssen, LP | INDUSTRY |
| Apices Soluciones S.L. | INDUSTRY |
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Prostate cancer is the most frequently diagnosed non-skin cancer, and the second leading cause of men cancer death in the United States. Hormonal therapy remains a first-line treatment for metastatic prostate cancer. Initial responses to hormonal therapy with chemical or surgical castration are quite favorable, however, most patients will progress to a castration-resistant phase of the disease. Docetaxel is the primary chemotherapeutic option for patients with mCRPC.
Abiraterone is a novel, selective, irreversible, and potent inhibitor of 17-[alpha]-hydroxylase/17,20-lyase (CYP17) enzymatic activity that has recently been demonstrated to further reduce testosterone levels in the blood to undetectable range (< 1 ng/dL) and is suggested to reduce de novo intratumor androgen synthesis. Abiraterone demonstrated activity in castration resistant prostate cancer patients previously treated with docetaxel chemotherapy. Recently, results of a phase III trial comparing abiraterone plus prednisone vs placebo plus prednisone in asymptomatic and without visceral metastasis, castration-resistant metastatic prostate cancer patients, demonstrated a better radiological progression free survival for abiraterone treated patients and a trend towards a better survival was clear for abiraterone treated patients.
No clinical evidence exists about efficacy of chemotherapy and antiandrogen therapy combination. All trials have been performed in patients in which LHRH agonist treatment was continued although there is not clear evidence about efficacy of hormonal treatment. Some retrospective studies suggest that androgen deprivation treatment should be maintained in chemotherapy treated patients. Abiraterone has been proved to suppress androgen levels to negative values, and to add efficacy to castration hormonal therapy. Combination of abiraterone with docetaxel chemotherapy seems promising adding efficacy to only docetaxel chemotherapy. A randomized phase II study comparing docetaxel + prednisone + abiraterone to docetaxel + prednisone in mCRPC in patients treated previously with abiraterone, seems promising to explore addition of efficacy to taxotere after abiraterone hormonal treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d |
|
| Arm B | Active Comparator | docetaxel 75 mg/m2 + prednisone 10 mg/d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d | Drug | Docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d in 21 day cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1 year radiologic progression free survival | Time from randomization to radiologic disease progression | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time from randomization to death | Up to 3 years |
| Radiologic progression free survival | Time from randomization to radiologic progression free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miguel A Climent, MD | Fundación Instituto Valenciano de Oncología | Study Chair |
| José A Arranz, MD | HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN, Servicio de Oncología Médica | Principal Investigator |
| Daniel E Castellano, MD | HOSPITAL UNIVERSITARIO 12 DE OCTUBRE,Servicio de Oncología Médica | Principal Investigator |
| Begoña Mellado, MD | HOSPITAL CLINIC I PROVINCIAL DE BARCELONA, Servicio de Oncología Médica | Principal Investigator |
| Albert Font, MD | HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL, Servicio de Oncología Médica | Principal Investigator |
| Alfredo Sánchez, MD | CONSORCIO HOSPITALARIO PROVINCIAL DE CASTELLÓN, Servicio de Oncología Médica | Principal Investigator |
| Emilio Esteban, MD | HOSPITAL UNIVERSITARIO CENTRAL DE ASTURIAS, Servicio de Oncología Médica | Principal Investigator |
| María I Sáez, MD | HOSPITAL VIRGEN DE LA VICTORIA, Servicio de Oncología Médica | Principal Investigator |
| Carmen Santander, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Son Espases | Palma de Mallorca | Balearic Islands | 07120 | Spain | ||
| Hospital Universitari Germans Trias I Pujol |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36099670 | Derived | Climent MA, Font A, Duran I, Puente J, Jose Mendez-Vidal M, Saez MI, Santander Lobera C, Angel Arranz Arija J, Gonzalez-Del-Alba A, Sanchez-Hernandez A, Juan Fita MJ, Esteban E, Alonso-Gordoa T, Mellado Gonzalez B, Maroto P, Lazaro-Quintela M, Cassinello-Espinosa J, Perez-Valderrama B, Garcias C, Castellano D. A phase II randomised trial of abiraterone acetate plus prednisone in combination with docetaxel or docetaxel plus prednisone after disease progression to abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer: The ABIDO-SOGUG trial. Eur J Cancer. 2022 Nov;175:110-119. doi: 10.1016/j.ejca.2022.08.002. Epub 2022 Sep 11. |
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| docetaxel 75 mg/m2 + prednisone 10 mg/d | Drug | Docetaxel 75 mg/m2 plus prednisone 10 mg/d in 21 day cycles. |
|
|
| Up to 1 year |
| PSA progression free survival | Time from randomization to PSA progression | Up to 3 weeks |
| PSA response rate | 50% & 90% PSA reduction from randomisation | Up to 3 weeks |
| Objective response rate | Response according RECIST criteria | Up to 12 weeks |
| Quality of life rate | Quality of life according to FACT-P questionaire | Up to 12 weeks |
| Time to skeletal-related event | Time from randomization to skeletal-related events | Up to 12 weeks |
| Time to opiate use for cancer pain | Time from randomization to opiate use for cancer pain | Up to 3 weeks |
| Time to pain progression | Time from randomization to pain progression defined as an increase in median BPI score ≥ 30% from baseline | Up to 3 weeks |
| Safety profile | Related adverse events per patient | Up to 3 weeks |
| HOSPITAL UNIVERSITARIO MIGUEL SERVET, Servicio de Oncología Médica |
| Principal Investigator |
| Pablo Maroto, MD | HOSPITAL DE LA SANTA CREU I SANT PAU, Servicio de Oncología Médica | Principal Investigator |
| Carmen Garcias de España, MD | HOSPITAL UNIVERSITARI SON ESPASES, Servicio de Oncología Médica | Principal Investigator |
| Teresa Alonso, MD | HOSPITAL RAMÓN Y CAJAL, Servicio de Oncología Médica | Principal Investigator |
| Javier Puente, MD | HOSPITAL CLÍNICO SAN CARLOS, Servicio de Oncología Médica | Principal Investigator |
| Martín Lázaro, Md | COMPLEXO HOSPITALARIO UNIVERSITARIO DE VIGO, Servicio de Oncología Médica | Principal Investigator |
| Javier Cassinello, MD | HOSPITAL UNIVERSITARIO DE GUADALAJARA, Servicio de Oncología Médica | Principal Investigator |
| María J Méndez, MD | COMPLEJO HOSPITALARIO REGIONAL REINA SOFÍA, Servicio de Oncología Médica | Principal Investigator |
| Begoña Perez-Valderrama, MD | COMPLEJO HOSPITALARIO REGIONAL VIRGEN DEL ROCIO, Servicio de Oncología Médica | Principal Investigator |
| Badalona |
| Barcelona |
| 08916 |
| Spain |
| Consorcio Hospitalario Provincial de Castellón | Castellon | Castellón | 12002 | Spain |
| Complexo Hospitalario Universitario de Vigo | Vigo | Pontevedra | 36036 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33006 | Spain |
| Hospital de La Santa Creu I Sant Pau | Barcelona | 08025 | Spain |
| Hospital Clinic I Provincial de Barcelona | Barcelona | 08036 | Spain |
| Complejo Hospitalario Regional Reina Sofía | Córdoba | 14004 | Spain |
| Hospital Universitario de Guadalajara | Guadalajara | 19002 | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Ramón Y Cajal | Madrid | 28034 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Virgen de La Victoria | Málaga | 29010 | Spain |
| Complejo Hospitalario Regional Virgen Del Rocio | Seville | 41013 | Spain |
| Fundación Instituto Valenciano de Oncología | Valencia | 46009 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D011241 | Prednisone |
| C089740 | abiraterone |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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