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Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy
This study is currently recruiting participants.
Verified February 2012 by National Cancer Institute (NCI)

First Received on March 4, 2011.   Last Updated on February 7, 2012   History of Changes
Sponsor: Southwest Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01309672
  Purpose

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antiandrogen drugs, such as abiraterone acetate, may lessen the amount of androgens made by the body. It may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects and how well abiraterone acetate works in treating patients with prostate cancer who have undergone initial hormone therapy.


Condition Intervention Phase
Prostate Cancer
Drug: abiraterone acetate
Drug: degarelix
Drug: goserelin acetate
Drug: leuprolide acetate
Procedure: orchiectomy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Abiraterone Acetate Treatment for Prostate Cancer Patients With a PSA of More Than Four Following Initial Androgen Deprivation Therapy Phase II

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Rates of undetectable PSA [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival and objective progression-free survival [ Designated as safety issue: No ]
  • Toxicity of abiraterone acetate [ Designated as safety issue: Yes ]

Estimated Enrollment: 38
Study Start Date: September 2011
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To assess the rate of achieving a prostate-specific antigen (PSA) of ≤ 0.2 ng/mL with abiraterone acetate therapy in men with metastatic prostate cancer with a sub-optimal response to androgen-deprivation therapy (ADT).

Secondary

  • To assess the overall survival and objective progression-free survival of this group of patients.
  • To assess PSA partial response.
  • To evaluate the qualitative and quantitative toxicity of abiraterone acetate.

OUTLINE: This is a multicenter study.

Patients receive abiraterone acetate orally daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive androgen blockade with GNRH agonist (goserelin acetate or leuprolide acetate) or a GNRH antagonist (degarelix) per the treating physician and this will be given continuously until evidence of disease progression. Bilateral surgical orchiectomy is also acceptable.

After completion of study therapy, patients are followed up every 3 months for 1 year and then every 6 months for up to 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically proven diagnosis of adenocarcinoma of the prostate

    • Metastatic (M1) disease as evidenced by soft tissue and/or bony metastases at the time of initiation of androgen-deprivation therapy (ADT)
    • Must have at least one of the following:

      • Visceral disease (liver, lung, other viscera)
      • Bone metastases to sites in either the axial (spine, pelvis, ribs, or skull) and/or the appendicular (clavicle, humerus, or femur) skeleton
      • Distant lymph node disease (e.g., above the aortic bifurcation, etc.)
    • No small cell or neuroendocrine prostate cancer
  • Patients must be receiving ADT (e.g., gonadotropin-releasing hormone (GNRH) antagonist, with or without antiandrogen) prior to entering this study

    • Degarelix, a FDA-approved is an acceptable form of ADT
  • Suboptimal response to ADT induction as defined by the following criteria:

    • Declining PSA (current PSA is less than the PSA prior to starting ADT) that fails to reach 4 ng/mL or below despite continuous ADT

      • PSA of > 4 ng/mL must be observed between 6-9 months after the initiation of ADT
      • No patients with a rising PSA
    • No patients with radiographic progression when compared to available imaging studies performed prior to starting the GNRH agonist/antagonist therapy
  • Patients who have measurable disease must have radiographic assessment (at least an abdominal/pelvic CT scan) within 28 days prior to registration
  • Non-measurable disease must be assessed (i.e., bone scan) within 42 days prior to registration
  • No patients with a history of brain metastases or who currently have treated or untreated brain metastases

    • Patients with clinical evidence of brain metastases must have a brain CT scan or MRI negative for metastatic disease within 56 days prior to registration

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • ANC ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Hemoglobin ≥ 10 g/dL
  • Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min
  • Bilirubin ≤ 1.5 times ULN (unless documented Gilbert disease)
  • AST and ALT < 2.5 times ULN
  • Potassium ≥ 3.5 mmol/L
  • Albumin > 3.5 g/dL
  • Patient must have a testosterone value of < 50 ng/dL obtained within 28 days prior to registration
  • Patients must have controlled blood pressure defined as systolic blood pressure < 160 mm Hg and diastolic blood pressure < 95 mm Hg

    • Patients with a history of hypertension are eligible provided blood pressure is controlled by anti-hypertensive treatment
  • Patients who have partners of child-bearing potential must be willing to use a method of birth control with adequate barrier protection during the study and for 13 weeks after the last study drug administration
  • Must be able to take oral medication without crushing, dissolving, or chewing tablets
  • No other prior malignancy is allowed except for any of the following:

    • Adequately treated basal cell or squamous cell skin cancer
    • Adequately treated stage I or II cancer from which the patient is currently in complete remission
    • Any other cancer from which the patient has been disease-free for 5 years
  • No patients with active or symptomatic viral hepatitis or chronic liver disease

    • No moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
  • No history of NYHA class III or IV heart failure

    • Patients must have LVEF ≥ 50%

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 2 years since prior neoadjuvant or adjuvant gonadotropin-releasing hormone (GNRH) agonist/antagonist therapy (related to previous surgery or radiation)

    • Prior enrollment to SWOG-S0925 (either arm) is not exclusionary, as long as appropriate wash-out periods are observed
  • At least 6 weeks since prior and no concurrent finasteride or dutasteride
  • At least 28 days since prior radiotherapy or surgery and recovered
  • At least 14 days since prior investigational products
  • At least 4 weeks since prior flutamide (6 weeks for bicalutamide and nilutamide) with no evidence of a falling PSA

    • No other concurrent oral antiandrogen
  • No prior or concurrent cytotoxic chemotherapy or radiopharmaceuticals for prostate cancer
  • No prior or concurrent ketoconazole for the treatment of prostate cancer
  • Not requiring more than 10 mg a day of prednisone for another medical indication
  • Not planning to receive any concurrent cytotoxic chemotherapy, immunotherapy, surgery, or radiotherapy during protocol treatment
  • No concurrent hormonal-acting agents, including diethylstilbestrol/DES, aldosterone, PC-SPES, or spironolactone
  • No concurrent antifungal medication (e.g., fluconazole or itraconazole)
  • No medications that alter cardiac conduction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309672

  Show 143 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Principal Investigator: Thomas W. Flaig, MD University of Colorado, Denver
  More Information

Additional Information:
No publications provided

Responsible Party: Laurence H. Baker, Southwest Oncology Group - Group Chair's Office
ClinicalTrials.gov Identifier: NCT01309672     History of Changes
Other Study ID Numbers: CDR0000696565, SWOG-S1014
Study First Received: March 4, 2011
Last Updated: February 7, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
hormone-resistant prostate cancer
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2012