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

NCT ID: NCT02036060

Last Updated: 2020-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-07

Study Completion Date

2020-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Prostate Cancer

Keywords

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Metastatic prostate cancer Abiraterone acetate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d

Group Type EXPERIMENTAL

docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d

Intervention Type DRUG

Docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d in 21 day cycles.

Arm B

docetaxel 75 mg/m2 + prednisone 10 mg/d

Group Type ACTIVE_COMPARATOR

docetaxel 75 mg/m2 + prednisone 10 mg/d

Intervention Type DRUG

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

Interventions

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docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d

Docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d in 21 day cycles.

Intervention Type DRUG

docetaxel 75 mg/m2 + prednisone 10 mg/d

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

Intervention Type DRUG

Other Intervention Names

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Arm A Arm B

Eligibility Criteria

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Inclusion Criteria

* 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
* Life expectancy of at least 6 months
* Patients who have partners of childbearing potential must be willing to use a method of birth control

Exclusion Criteria

* 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
* History of pituitary or adrenal dysfunction
* Clinically significant heart disease
* Atrial Fibrillation, or other cardiac arrhythmia requiring therapy
* Other malignancy, except non-melanoma skin cancer, with a \>= 30% probability of recurrence within 24 months
* Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1
* Any condition which, in the opinion of the investigator, would preclude participation in this trial.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Janssen, LP

INDUSTRY

Sponsor Role collaborator

Apices Soluciones S.L.

INDUSTRY

Sponsor Role collaborator

Spanish Oncology Genito-Urinary Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Miguel A Climent, MD

Role: STUDY_CHAIR

Fundación Instituto Valenciano de Oncología

José A Arranz, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN, Servicio de Oncología Médica

Daniel E Castellano, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL UNIVERSITARIO 12 DE OCTUBRE,Servicio de Oncología Médica

Begoña Mellado, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL CLINIC I PROVINCIAL DE BARCELONA, Servicio de Oncología Médica

Albert Font, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL, Servicio de Oncología Médica

Alfredo Sánchez, MD

Role: PRINCIPAL_INVESTIGATOR

CONSORCIO HOSPITALARIO PROVINCIAL DE CASTELLÓN, Servicio de Oncología Médica

Emilio Esteban, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL UNIVERSITARIO CENTRAL DE ASTURIAS, Servicio de Oncología Médica

María I Sáez, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL VIRGEN DE LA VICTORIA, Servicio de Oncología Médica

Carmen Santander, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL UNIVERSITARIO MIGUEL SERVET, Servicio de Oncología Médica

Pablo Maroto, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL DE LA SANTA CREU I SANT PAU, Servicio de Oncología Médica

Carmen Garcias de España, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL UNIVERSITARI SON ESPASES, Servicio de Oncología Médica

Teresa Alonso, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL RAMÓN Y CAJAL, Servicio de Oncología Médica

Javier Puente, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL CLÍNICO SAN CARLOS, Servicio de Oncología Médica

Martín Lázaro, Md

Role: PRINCIPAL_INVESTIGATOR

COMPLEXO HOSPITALARIO UNIVERSITARIO DE VIGO, Servicio de Oncología Médica

Javier Cassinello, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL UNIVERSITARIO DE GUADALAJARA, Servicio de Oncología Médica

María J Méndez, MD

Role: PRINCIPAL_INVESTIGATOR

COMPLEJO HOSPITALARIO REGIONAL REINA SOFÍA, Servicio de Oncología Médica

Begoña Perez-Valderrama, MD

Role: PRINCIPAL_INVESTIGATOR

COMPLEJO HOSPITALARIO REGIONAL VIRGEN DEL ROCIO, Servicio de Oncología Médica

Locations

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Hospital Universitari Son Espases

Palma de Mallorca, Balearic Islands, Spain

Site Status

Hospital Universitari Germans Trias I Pujol

Badalona, Barcelona, Spain

Site Status

Consorcio Hospitalario Provincial de Castellón

Castellon, Castellón, Spain

Site Status

Complexo Hospitalario Universitario de Vigo

Vigo, Pontevedra, Spain

Site Status

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status

Hospital de La Santa Creu I Sant Pau

Barcelona, , Spain

Site Status

Hospital Clinic I Provincial de Barcelona

Barcelona, , Spain

Site Status

Complejo Hospitalario Regional Reina Sofía

Córdoba, , Spain

Site Status

Hospital Universitario de Guadalajara

Guadalajara, , Spain

Site Status

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status

Hospital Ramón Y Cajal

Madrid, , Spain

Site Status

Hospital Clínico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Virgen de La Victoria

Málaga, , Spain

Site Status

Complejo Hospitalario Regional Virgen Del Rocio

Seville, , Spain

Site Status

Fundación Instituto Valenciano de Oncología

Valencia, , Spain

Site Status

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 36099670 (View on PubMed)

Other Identifiers

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2013-003811-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ABIDO-SOGUG

Identifier Type: -

Identifier Source: org_study_id