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


Phase 2
20 Years
80 Years
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rate of undetectable PSA (<0.1 ng/ml)

Outcome Description:

Undetectable PSA at 1 year from treatment initiation

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Bridget Koontz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00044071

NCT ID:

NCT01717053

Start Date:

September 2013

Completion Date:

September 2016

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Durham Regional HospitalDurham, North Carolina  27704-2763
Duke University Medical CenterDurham, North Carolina  27710