Abiraterone, Radiotherapy and Short-Term Androgen Deprivation in Unfavorable Localized Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Duke University
Sponsor:
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01717053
First received: October 26, 2012
Last updated: April 28, 2014
Last verified: April 2014

October 26, 2012
April 28, 2014
September 2013
September 2015   (final data collection date for primary outcome measure)
Rate of undetectable PSA (<0.1 ng/ml) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Undetectable PSA at 1 year from treatment initiation
Same as current
Complete list of historical versions of study NCT01717053 on ClinicalTrials.gov Archive Site
  • PSA nadir value [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
    PSA nadir values at 1 and 2 years
  • Time to PSA nadir [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Biochemical progression-free survival [ Time Frame: up to 2.5 years ] [ Designated as safety issue: No ]
    Disease progression defined as Phoenix RTOG definition of nadir + 2ng/ml or initiation of salvage therapy
  • Metastasis or systemic therapy [ Time Frame: up to 2.5 years ] [ Designated as safety issue: No ]
    Time to metastasis or systemic therapy
  • Testosterone recovery [ Time Frame: up to 2.5 years ] [ Designated as safety issue: No ]
    Time to testosterone recovery
  • PSA < 1.5ng/ml in setting of non-castrate testosterone [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
    Proportion of men with 1 and 2 year PSA < 1.5ng/ml in setting of non-castrate testosterone
  • Safety and tolerability [ Time Frame: up to 7 months ] [ Designated as safety issue: Yes ]
    To evaluate the short and long term safety and tolerability of 6 months of abiraterone acetate with prednisone and ADT combined with standard RT in men with intermediate/lower high risk localized prostate cancer
  • PSA nadir value [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Time to PSA nadir [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Abiraterone, Radiotherapy and Short-Term Androgen Deprivation in Unfavorable Localized Prostate Cancer
A Phase II Trial of Abiraterone Acetate, Radiotherapy and Short-Term Androgen Deprivation in Men With Unfavorable Risk Localized Prostate Cancer

The addition of abiraterone acetate to standard treatment of radiotherapy and short-term androgen deprivation will increase the frequency of undetectable PSA.

This is a single arm two-site study of 37 men with unfavorable prostate cancer (defined as having a single high risk factor). Patients will concurrently initiate 6 months of standard-of-care GNRH agonist therapy and once daily abiraterone acetate/prednisone. After 2 months of lead-in hormonal treatment, definitive standard-of-care prostate/seminal vesicle radiotherapy will be delivered, to a total dose of 75-80 Gy.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: Abiraterone acetate
    1000 mg orally once a day for 6 months.
    Other Name: Zytiga
  • Drug: Androgen deprivation
    Leuprolide acetate (22.5mg IM) or goserelin acetate (10.8mg SC) will be administered every 3 months for 2 doses
  • Radiation: Radiation Therapy
    Daily (Monday-Friday) for 8 weeks, final dose of 75-80 Gy
  • Drug: Prednisone
    5 mg tablet once daily for 6 months.
Experimental: Abiraterone acetate
Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
Interventions:
  • Drug: Abiraterone acetate
  • Drug: Androgen deprivation
  • Radiation: Radiation Therapy
  • Drug: Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
37
September 2016
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Gleason Score 7 with PSA < 20 ng/ml and T1-2b exam, or
  • Gleason Score 8-10, PSA ≤ 20 ng/ml and T1 exam, or
  • PSA 10.1-30 ng/ml with GS < 7 and T1 exam, or
  • Clinical T3 with Gleason Score < 7 and PSA < 10 ng/ml. T3 clinical stage may be based on exam or imaging (MRI, CT, ultrasound) prior to entry
  • ECOG Performance Status ≤ 1
  • Serum testosterone >150 ng/dl prior to start of androgen deprivation
  • CBC with differential with adequate bone marrow function defined as follows:
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3, Platelets > 100,000/µL and Hemoglobin > 9g/dL
  • Serum potassium ≥ 3.5 mEq/L
  • Serum albumin > 3.0 g/dl
  • Total bilirubin < 1.5 X of institutional upper limit of normal (ULN)
  • AST(SGOT)/ALT(SGPT) < 1.5 X ULN
  • Calculated creatinine clearance > 60 mL/min
  • Age > 18 years
  • Able to swallow a whole tablet and take abiraterone acetate on an empty stomach (defined as no food for two hours before and one hour after abiraterone acetate ingestion)
  • Ability to understand and sign a written informed consent document
  • Written authorization for use and release of health and research study information has been obtained
  • Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
  • Subjects who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protections as determined acceptable by the principal investigator during the study and for 1 week after the last dose of abiraterone acetate.

Exclusion Criteria:

  • Bone, visceral or soft tissue metastasis, including lymph nodes
  • Prior therapy for prostate cancer
  • Previous malignancy within 3 years other than non-melanomatous skin cancer and non-muscle invasive bladder cancer
  • Previous pelvic radiotherapy that would prevent prostate/SV irradiation
  • Uncontrolled hypertension
  • History of gastrointestinal disorders that may interfere with the absorption of study drug (including gastric bypass surgery)
  • Concurrent spironolactone use
  • Significant concurrent medical condition that would make prednisone/prednisolone use contraindicated
  • Receiving any investigational agents currently or within 30 days prior to study screening
  • Prior demonstrated hypersensitivity, intolerance or allergy to abiraterone acetate, prednisone or their excipients
  • Active co-morbidity, defined as follows:

    • Chronic liver disease with cirrhosis (Child-Pugh B or C) or active hepatitis B or C
    • History of pituitary or adrenal dysfunction
    • Poorly controlled diabetes mellitus (A1c >9% or history of complications including peripheral neuropathy, end organ damage, hospitalization, amputation)
    • Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III-IV heart disease or known cardiac ejection fraction measurement of < 50% at baseline.
    • Clinical evidence of active infection of any type, including active or symptomatic viral hepatitis.
    • Known immune deficiency and/or HIV-positive patients
    • Any medical condition that warrants long-term corticosteroid use in excess of study dose
  • Patients taking strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital)
  • Any condition that in the opinion of the Principal Investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing the study requirements
Male
18 Years and older
No
Contact: Ellen Bratt, RN 919-684-7590 ellen.bratt@duke.edu
United States
 
NCT01717053
Pro00044071
No
Duke University
Duke University
Janssen Pharmaceuticals
Principal Investigator: Bridget Koontz, MD Duke University
Duke University
April 2014

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