Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Prostatic Neoplasms

Disease Progression

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Kennedy Disease

All Drugs and Chemicals

Antineoplastic Agents

Anti-Inflammatory Agents

Androgens

Abiraterone Acetate

Prednisone

Dutasteride

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

5-alpha Reductase Inhibitors

Abiraterone acetate 1000mg orally once per day + prednisone 5mg orally once per day for two months, followed by abiraterone 1000mg orally once per day + prednisone 5mg orally once per day + dutasteride 3.5mg orally once per day in 28-day cycles until symptomatic or radiographic progression

Abiraterone acetate

Mary-Ellen Taplin, M.D.

The purpose of this research study is to determine if the addition of dutasteride to a regimen with abiraterone acetate and prednisone will improve on therapy in patients with castrate-resistant prostate cancer and metastatic disease. This study will also help determine the side effects of the study treatment and how often they occur.

Patients will receive abiraterone acetate and prednisone orally, once daily for 2 months (2 cycles) on an outpatient basis. At the start of cycle 3, dutasteride will be taken once daily. Patients will return to the clinic on Day 14 of the first 3 cycles for routine blood tests.

Patients will come to the clinic every 12 weeks for a CT scan and/or x-ray of the chest, CT scan or MRI of the abdomen and pelvis, bone scan, and blood test for testosterone and other specialized blood test.

Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer

Phase II Trial of Abiraterone Acetate Combined With Dutasteride With Correlative Assessment of Tumor Androgen Levels and Androgen Receptor Sequence and Signaling at Baseline and at Progression

AR related mutation was defined as presence of T878A mutation. Expression of T878A was measured by established methods.

Serum testosterone levels were estimated based on established methods. The change from baseline to progression was calculated for each participant.

PSA response was defined as decline of 50% from baseline confirmed by a PSA at least 4 weeks later based on Prostate-specific Antigen Working Group-2 (PSAWG-2) (2008) criteria.

Time to PSA progression based on the Kaplan-Meier method was defined as the time between registration and documented PSA progression. PSA progression based on Prostate-Specific Antigen Working Group-2 (PSAWG-2) (2008) criteria was an increase of \>/=25% and \>/= 2 ng/ml after 12 weeks for patients without a PSA decline from baseline and an increase of \>/=25% and \>/= 2 ng/ml above the nadir, confirmed by a 2nd value 3 weeks or later for patients with a PSA decline from baseline. PSA progression was reported not duration of response.

Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

TTP based on the Kaplan-Meier method is defined as the duration of time from study entry to documented first observation of progressive disease (PD). Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Presence of AR amplification was measured by established methods.

Serum androgen levels measured based on established methods. The change from baseline to progression was calculated for each participant.

CTCs were measured based on established methods.

Mary-Ellen Taplin, MD

Associate Professor of Medicine, HMS

Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated. Patients appear once for a given toxicity type. Serious and Other Adverse Events (AEs) were defined as events of grades 3-5 and grades 1-2, respectively, based on Common Terminology Criteria for Adverse Events version 4 (CTCAEv4). 'Other' events have no further specification.

Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression

Abiraterone acetate: 1000 mg orally, once per day

Dutasteride: 3.5 mg orally once per day

Prednisone: 5 mg orally once per day

Spots Global Cancer Trial Database for Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer

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Interventions

Study Description

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Eligibility

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