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

This study is not yet open for participant recruitment.

Verified May 2013 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: May 3, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 26, 2012

Last Updated Date

May 3, 2013

Start Date ^ICMJE

September 2013

Estimated Primary Completion Date

September 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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
Biochemical progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Disease progression defined as Phoenix RTOG definition of nadir + 2ng/ml or initiation of salvage therapy

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01717053 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase II Trial of Abiraterone, Radiotherapy and Short-Term Androgen Deprivation in Men With Unfavorable Localized Prostate Cancer

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

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
Drug: Prednisone
5 mg tablet twice daily for 6 months.

Study Arm (s)

Experimental: Abiraterone acetate

Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation

Interventions:

Drug: Abiraterone acetate
Drug: Androgen deprivation
Radiation: Radiation Therapy
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

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2016

Estimated Primary Completion Date

September 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Gleason Score 7 with PSA < 20 ng/ml and T1-2b exam, or
Gleason Score 8-10 with less than 50% cores positive, PSA ¬¬< 10 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
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

Exclusion Criteria:

Bone 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
Uncontrolled hypertension
History of gastrointestinal disorders that may interfere with the absorption of study drug (including gastric bypass surgery)
Significant concurrent medical condition that would make prednisone/prednisolone use contraindicated

Gender

Male

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01717053

Other Study ID Numbers ^ICMJE

Pro00044071

Has Data Monitoring Committee

Responsible Party

Duke University

Study Sponsor ^ICMJE

Duke University

Collaborators ^ICMJE

Janssen Pharmaceuticals

Investigators ^ICMJE

Principal Investigator:

Bridget Koontz, MD

Duke University

Information Provided By

Duke University

Verification Date

May 2013

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

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