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S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01309672
Recruitment Status : Active, not recruiting
First Posted : March 7, 2011
Results First Posted : May 5, 2017
Last Update Posted : December 16, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Tracking Information
First Submitted Date  ICMJE March 4, 2011
First Posted Date  ICMJE March 7, 2011
Results First Submitted Date  ICMJE March 23, 2017
Results First Posted Date  ICMJE May 5, 2017
Last Update Posted Date December 16, 2019
Study Start Date  ICMJE August 9, 2011
Actual Primary Completion Date November 29, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
Number of Patients With Undetectable PSA [ Time Frame: 12 months ]
undetectable PSA defined as <= 0.2 ng/mL. Patients not responding in the first year were deemed non-responders.
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2011)
Rates of Undetectable PSA
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
  • Number of Patients With PSA Partial Response [ Time Frame: 12 months ]
    PSA reduction to < 4 ng/ml, but >0.2 ng/ml
  • Objective Progression-free Survival [ Time Frame: 3 years ]
    Progression defined as unequivocal progression of disease, progressive disease as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), progressive disease as defined by the Prostate Cancer Clinical Trials Working Group bone scan progression criteria, or death due to disease.
  • Overall Survival [ Time Frame: 3 years ]
  • Number of Patients With Toxicity of Abiraterone Acetate [ Time Frame: Up to 3 years ]
    Only adverse events that are possibly, probably or definitely related to study drug are reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2011)
  • Overall survival and objective progression-free survival
  • Toxicity of Abiraterone Acetate
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy
Official Title  ICMJE Abiraterone Acetate Treatment for Prostate Cancer Patients With a PSA of More Than Four Following Initial Androgen Deprivation Therapy Phase II
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: abiraterone acetate
    1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily
  • Drug: Prednisone
    5 mg, oral, 5 mg twice daily
Study Arms  ICMJE Experimental: Abiraterone acetate + prednisone

Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily

Prednisone, 5 mg, oral, 5 mg twice daily

Interventions:
  • Drug: abiraterone acetate
  • Drug: Prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 23, 2017)
41
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2011)
38
Estimated Study Completion Date  ICMJE October 2021
Actual Primary Completion Date November 29, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 GNRH antagonist, is an acceptable form of ADT
    • Bilateral surgical orchiectomy is also acceptable
  • 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 6-12 months after the initiation of ADT
      • Documentation of failure to achieve this PSA of ≤ 4 ng/mL must be within 28 days of registration

        • The PSA must be obtained after any applicable antiandrogen washout period
      • If the PSA is declining or stable (defined as a PSA rise ≤ 0.1 ng/mL from nadir) and the patient is on an antiandrogen, they must remain on the antiandrogen
      • Patients with stable or declining PSA who have had previous antiandrogen exposure, but are not taking an antiandrogen at the time of registration, must wait at least 6 weeks from the last antiandrogen dose before registration and still demonstrate a stable or falling PSA which is > 4 ng/mL by month 12, in order to be eligible
      • If the PSA is rising and they are on an antiandrogen, formal antiandrogen washout must be performed (4 weeks for flutamide and 6 weeks for bicalutamide and nilutamide with no evidence of a falling PSA after washout)
    • 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 < 1.5 times ULN
  • Potassium ≥ 3.5 mmol/L
  • 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 1 week after the last study drug administration
  • Must be able to take oral medication without crushing, dissolving, or chewing tablets
  • Patients must not have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of abiraterone acetate
  • 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%
  • No known allergies, hypersensitivity, or intolerance to abiraterone acetate, prednisone, or their excipients

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Patients with a history of prior neoadjuvant or adjuvant GNRH agonist/antagonist therapy (related to previous surgery or radiation) are eligible provided they finished this therapy at least two years prior to registration

    • Prior enrollment to SWOG-S0925 (either arm) is not exclusionary
  • 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 4 weeks 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
  • No prior Provenge (sipuleucel-T)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01309672
Other Study ID Numbers  ICMJE CDR0000696565
S1014 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://swog.org/Visitors/Download/Policies/Policy43.pdf
Responsible Party Southwest Oncology Group
Study Sponsor  ICMJE Southwest Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Thomas W. Flaig, MD University of Colorado, Denver
PRS Account Southwest Oncology Group
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP