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Completed

NCT Number: NCT01393730

Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abiraterone Acetate

Drug

Other names: CB7630

dutasteride

Drug

Other names: Avodart

Prednisone

Drug

Other names: Corticosteroid

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Mary-Ellen Taplin, MD

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Jul 13, 2011
Registry last updated
Mar 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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