Abiraterone Acetate in Combination With Docetaxel After Disease Progression to Abiraterone Acetate in Metastatic Castration Resistant Prostate Cancer.

NCT02036060 | Completed Phase 2

• 2 other identifiers: ABIDO-SOGUG2013-003811-23
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Metastatic Prostate Cancer

Keywords

Metastatic prostate cancer; Abiraterone acetate

Outcome Measures

Primary Outcomes (1)

• 1 year radiologic progression free survival

  Time from randomization to radiologic disease progression

  1 year

Secondary Outcomes (10)

• Overall survival

  Up to 3 years

• Radiologic progression free survival

  Up to 1 year

• PSA progression free survival

  Up to 3 weeks

• PSA response rate

  Up to 3 weeks

• Objective response rate

  Up to 12 weeks

Study Arms (2)

Arm A

EXPERIMENTAL

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

Arm B

ACTIVE COMPARATOR

docetaxel 75 mg/m2 + prednisone 10 mg/d

Drug: docetaxel 75 mg/m2 + prednisone 10 mg/d

Interventions

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.

Also known as: Arm A

Arm A

docetaxel 75 mg/m2 + prednisone 10 mg/d DRUG

Docetaxel 75 mg/m2 plus prednisone 10 mg/d in 21 day cycles.

Also known as: Arm B

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent
• Male aged 18 years and above
• Histologically or cytologically confirmed adenocarcinoma of the prostate.
• Metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT, MRI.
• Prostate cancer progression to previous castration treatment documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria or bone scan progression
• Asymptomatic or mildly symptomatic from prostate cancer
• Surgically or medically castrated, with testosterone levels of \< 50 ng/dL (\< 2.0 nM).
• Previous anti-androgen therapy and progression after withdrawal.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Hemoglobin \>= 10.0 g/dL independent of transfusion
• Platelet count \>= 100,000/µL
• Serum albumin \>= 3.5 g/dL
• Serum creatinine \< 1.5 x ULN or a calculated creatinine clearance \>= 60 mL/min
• Serum potassium \>= 3.5 mmol/L
• Liver function: a. Serum bilirubin \< 1.5 x ULN (except for patients with documented Gilbert's disease) b. AST or ALT \< 2.5 x ULN

You may not qualify if:

• Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
• Any chronic medical condition requiring a higher dose of corticosteroid than 10mg prednisone/prednisolone daily.
• Pathological finding consistent with small cell carcinoma of the prostate
• Liver or visceral organ metastasis
• Known brain metastasis
• Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
• Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
• Radiation therapy for treatment of the primary tumor within 6 weeks of Cycle 1, Day
• Radiation or radionuclide therapy for treatment of metastatic CRPC
• Previously treated with ketoconazole for prostate cancer for greater than 7 days
• Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1
• Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1, Day 1
• Bicalutamide (Casodex), nilutamide (Nilandron) within 6 weeks of Cycle 1 Day 1
• Uncontrolled hypertension (systolic BP \>= 160 mmHg or diastolic BP \>= 95 mmHg).
• Active or symptomatic viral hepatitis or chronic liver disease

Sponsors & Collaborators

• Spanish Oncology Genito-Urinary Group: lead
• Janssen, LP: collaborator
• Apices Soluciones S.L.: collaborator

Study Sites (17)

Hospital Universitari Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Hospital Universitari Germans Trias I Pujol

Badalona, Barcelona, 08916, Spain

Location

Consorcio Hospitalario Provincial de Castellón

Castellon, Castellón, 12002, Spain

Location

Complexo Hospitalario Universitario de Vigo

Vigo, Pontevedra, 36036, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33006, Spain

Location

Hospital de La Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, 08036, Spain

Location

Complejo Hospitalario Regional Reina Sofía

Córdoba, 14004, Spain

Location

Hospital Universitario de Guadalajara

Guadalajara, 19002, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Ramón Y Cajal

Madrid, 28034, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Virgen de La Victoria

Málaga, 29010, Spain

Location

Complejo Hospitalario Regional Virgen Del Rocio

Seville, 41013, Spain

Location

Fundación Instituto Valenciano de Oncología

Valencia, 46009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (1)

• 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.

  PMID: 36099670 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Prednisone; abiraterone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• 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

  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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 14, 2014
• Study Start: February 7, 2014
• Primary Completion: June 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 16, 2020

Record last verified: 2020-10

Locations

ES (17)