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

Primary Purpose

Metastatic Prostate Cancer

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

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

docetaxel 75 mg/m2 + prednisone 10 mg/d

About this trial

This is an interventional treatment trial for Metastatic Prostate Cancer focused on measuring Metastatic prostate cancer, Abiraterone acetate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

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

docetaxel 75 mg/m2 + prednisone 10 mg/d

Outcomes

Primary Outcome Measures

1 year radiologic progression free survival

Time from randomization to radiologic disease progression

Secondary Outcome Measures

Overall survival

Time from randomization to death

Radiologic progression free survival

Time from randomization to radiologic progression free survival

PSA progression free survival

Time from randomization to PSA progression

PSA response rate

50% & 90% PSA reduction from randomisation

Objective response rate

Response according RECIST criteria

Quality of life rate

Quality of life according to FACT-P questionaire

Time to skeletal-related event

Time from randomization to skeletal-related events

Time to opiate use for cancer pain

Time from randomization to opiate use for cancer pain

Time to pain progression

Time from randomization to pain progression defined as an increase in median BPI score ≥ 30% from baseline

Safety profile

Related adverse events per patient

Full Information

NCT ID

NCT02036060

First Posted

January 10, 2014

Last Updated

November 12, 2020

Sponsor

Spanish Oncology Genito-Urinary Group

Collaborators

Janssen, LP, Apices Soluciones S.L.

1. Study Identification

Unique Protocol Identification Number

NCT02036060

Brief Title

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

Acronym

ABIDO

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.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

February 7, 2014 (Actual)

Primary Completion Date

June 2020 (Actual)

Study Completion Date

October 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Spanish Oncology Genito-Urinary Group

Collaborators

Janssen, LP, Apices Soluciones S.L.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Prostate Cancer

Keywords

Metastatic prostate cancer, Abiraterone acetate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

119 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

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

Arm Title

Arm B

Arm Type

Active Comparator

Arm Description

docetaxel 75 mg/m2 + prednisone 10 mg/d

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

Arm A

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

docetaxel 75 mg/m2 + prednisone 10 mg/d

Other Intervention Name(s)

Arm B

Intervention Description

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

Primary Outcome Measure Information:

Title

1 year radiologic progression free survival

Description

Time from randomization to radiologic disease progression

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Overall survival

Description

Time from randomization to death

Time Frame

Up to 3 years

Title

Radiologic progression free survival

Description

Time from randomization to radiologic progression free survival

Time Frame

Up to 1 year

Title

PSA progression free survival

Description

Time from randomization to PSA progression

Time Frame

Up to 3 weeks

Title

PSA response rate

Description

50% & 90% PSA reduction from randomisation

Time Frame

Up to 3 weeks

Title

Objective response rate

Description

Response according RECIST criteria

Time Frame

Up to 12 weeks

Title

Quality of life rate

Description

Quality of life according to FACT-P questionaire

Time Frame

Up to 12 weeks

Title

Time to skeletal-related event

Description

Time from randomization to skeletal-related events

Time Frame

Up to 12 weeks

Title

Time to opiate use for cancer pain

Description

Time from randomization to opiate use for cancer pain

Time Frame

Up to 3 weeks

Title

Time to pain progression

Description

Time from randomization to pain progression defined as an increase in median BPI score ≥ 30% from baseline

Time Frame

Up to 3 weeks

Title

Safety profile

Description

Related adverse events per patient

Time Frame

Up to 3 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: