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

• ClinicalTrials.gov Identifier: NCT02036060
• Recruitment Status: Completed
• First Posted: January 14, 2014
• Last Update Posted: November 16, 2020
• Sponsor: Spanish Oncology Genito-Urinary Group
• Collaborators: Janssen, LP; Apices Soluciones S.L.
• Information provided by (Responsible Party): Spanish Oncology Genito-Urinary Group

Tracking Information

• First Submitted Date: January 10, 2014
• First Posted Date: January 14, 2014
• Last Update Posted Date: November 16, 2020
• Actual Study Start Date: February 7, 2014
• Actual Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (submitted: November 12, 2020)

• 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 rate [ 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 (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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Abiraterone Acetate in Combination With Docetaxel After Disease Progression to Abiraterone Acetate in Metastatic Castration Resistant Prostate Cancer.
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Metastatic Prostate Cancer

Intervention

• 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

• 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 *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 13, 2014): 119
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 2020
• Actual Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT02036060
• Other Study ID Numbers: ABIDO-SOGUG; 2013-003811-23 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Spanish Oncology Genito-Urinary Group
• Original Responsible Party: Same as current
• Current Study Sponsor: Spanish Oncology Genito-Urinary Group
• Original Study Sponsor: Same as current

Collaborators

• Janssen, LP
• Apices Soluciones S.L.

Investigators

• 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: October 2020