Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02036060
Recruitment Status : Active, not recruiting
First Posted : January 14, 2014
Last Update Posted : September 23, 2019
Sponsor:
Collaborators:
Janssen, LP
Apices Soluciones S.L.
Information provided by (Responsible Party):
Spanish Oncology Genito-Urinary Group

Tracking Information
First Submitted Date  ICMJE January 10, 2014
First Posted Date  ICMJE January 14, 2014
Last Update Posted Date September 23, 2019
Actual Study Start Date  ICMJE February 7, 2014
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2014)
1 year radiologic progression free survival [ Time Frame: 1 year ]
Time from randomization to radiologic disease progression
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02036060 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2014)
  • Overall survival [ Time Frame: Up to 3 years ]
    Time from randomization to death
  • Radiologic progression free survival [ Time Frame: Up to 1 year ]
    Time from randomization to radiologic progression free survival
  • PSA progression free survival [ Time Frame: Up to 3 weeks ]
    Time from randomization to PSA progression
  • PSA response rate [ Time Frame: Up to 3 weeks ]
    50% & 90% PSA reduction from randomisation
  • Objective response rate [ Time Frame: Up to 12 weeks ]
    Response according RECIST criteria
  • Quality of life [ Time Frame: Up to 12 weeks ]
    Quality of life according to FACT-P questionaire
  • Time to skeletal-related event [ Time Frame: Up to 12 weeks ]
    Time from randomization to skeletal-related events
  • Time to opiate use for cancer pain [ Time Frame: Up to 3 weeks ]
    Time from randomization to opiate use for cancer pain
  • Time to pain progression [ Time Frame: Up to 3 weeks ]
    Time from randomization to pain progression defined as an increase in median BPI score ≥ 30% from baseline
  • Safety profile [ Time Frame: Up to 3 weeks ]
    Related adverse events per patient
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Abiraterone Acetate in Combination With Docetaxel After Disease Progression to Abiraterone Acetate in Metastatic Castration Resistant Prostate Cancer.
Official Title  ICMJE Abiraterone Acetate Maintenance in Combination With Docetaxel After Disease Progression to Abiraterone Acetate in Metastatic Castration Resistant Prostate Cancer. Randomized Phase II Study.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Prostate Cancer
Intervention  ICMJE
  • Drug: 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.
    Other Name: Arm A
  • Drug: docetaxel 75 mg/m2 + prednisone 10 mg/d
    Docetaxel 75 mg/m2 plus prednisone 10 mg/d in 21 day cycles.
    Other Name: Arm B
Study Arms  ICMJE
  • Experimental: Arm A
    docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d
    Intervention: Drug: docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d
  • Active Comparator: Arm B
    docetaxel 75 mg/m2 + prednisone 10 mg/d
    Intervention: Drug: docetaxel 75 mg/m2 + prednisone 10 mg/d
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 13, 2014)
119
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02036060
Other Study ID Numbers  ICMJE ABIDO-SOGUG
2013-003811-23 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Spanish Oncology Genito-Urinary Group
Study Sponsor  ICMJE Spanish Oncology Genito-Urinary Group
Collaborators  ICMJE
  • Janssen, LP
  • Apices Soluciones S.L.
Investigators  ICMJE
Study Chair: Miguel A Climent, MD Fundación Instituto Valenciano de Oncología
Principal Investigator: 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
PRS Account Spanish Oncology Genito-Urinary Group
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP