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Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01393730
First received: June 21, 2011
Last updated: May 12, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention Phase
Prostate Cancer Drug: Abiraterone acetate Drug: Dutasteride Drug: Prednisone Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Number of Participants With Androgen Receptor (AR) Related Mutations [ Time Frame: Pairs of patients samples were evaluated at baseline and time of progression. In this study cohort, participants were followed up to 48 months for this endpoint. ]
    AR related mutation was defined as presence of T878A mutation. Expression of T878A was measured by established methods.


Secondary Outcome Measures:
  • Change in Serum Levels of Testosterone [ Time Frame: Samples for testosterone analyses were obtained at baseline and at time of progression. In this study cohort, participants were followed up to 48 months for this endpoint. ]
    Serum testosterone levels were estimated based on established methods. The change from baseline to progression was calculated for each participant.

  • Prostate-Specific Antigen (PSA) Response [ Time Frame: PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint. ]
    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 [ Time Frame: PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint. ]
    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.

  • Best Overall Response [ Time Frame: Disease was evaluated radiologically at baseline and every 12 weeks cycles on treatment. In this study cohort, participants were followed up to 48 months for this endpoint. ]
    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.

  • Time to Progression (TTP) [ Time Frame: Disease evaluation occurred every 12 weeks while patients were receiving treatment. In this study cohort, participants were followed up to 48 months for this endpoint. ]
    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 [ Time Frame: Patients' samples were evaluated at baseline and every 12 weeks on treatment. In this study cohort, participants were followed up to 48 months for this endpoint. ]
    Presence of AR amplification was measured by established methods.

  • Change in Serum Androgen Levels [ Time Frame: Pairs of patients' samples for androgen analyses were obtained at baseline and at time of progression. In this study cohort, participants were followed up to 48 months for this endpoint. ]
    Serum androgen levels measured based on established methods. The change from baseline to progression was calculated for each participant.

  • Change in Circulating Tumor Cells (CTCs) Levels [ Time Frame: Pairs of patients' samples were evaluated at baseline and time of progression. In this study cohort, participants were followed up to 48 months for this endpoint. ]
    CTCs were measured based on established methods.


Enrollment: 40
Study Start Date: September 2011
Estimated Study Completion Date: January 2018
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abiraterone+prednisone+dutasteride
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
Drug: Abiraterone acetate
Other Name: CB7630
Drug: Dutasteride
Other Name: Avodart
Drug: Prednisone
Other Name: Corticosteroid

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of adenocarcinoma of the prostate
  • Castrate resistant disease
  • Metastatic disease
  • Normal organ and marrow function
  • Subjects with partners of childbearing potential must be willing to use adequate methods of birth control

Exclusion Criteria:

  • Uncontrolled intercurrent illness
  • Uncontrolled hypertension
  • Active or symptomatic viral hepatitis or chronic liver disease
  • History of pituitary or adrenal dysfunction
  • Clinically significant heart disease
  • History of a different malignancy unless disease-free for at least 5 years
  • Known brain metastasis
  • History of gastrointestinal disorders
  • Prior therapy with abiraterone acetate
  • HIV-positive individuals on antiretroviral therapy
  • Requirement for steroid use greater than the equivalent of 5 mg of prednisone daily
  • Atrial fibrillation or other cardiac arrhythmia requiring therapy
  • Thromboembolism in the last 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393730

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Mary-Ellen Taplin, MD
Investigators
Principal Investigator: Mary-Ellen Taplin, M.D. Dana-Farber Cancer Institute
  More Information

Publications:
Responsible Party: Mary-Ellen Taplin, MD, Associate Professor of Medicine, HMS, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01393730     History of Changes
Other Study ID Numbers: 10-448
Study First Received: June 21, 2011
Results First Received: March 17, 2017
Last Updated: May 12, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: This will not be done.

Keywords provided by Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute:
prostate
metastatic
castrate resistant

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Abiraterone Acetate
Dutasteride
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 26, 2017