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

NCT01717053 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2022-10-10

Study results available
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Summary

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

Conditions

Interventions

DRUG

Abiraterone acetate

1000 mg orally once a day for 6 months.

DRUG

Androgen deprivation

LHRH analog (at discretion of treating physician) will be administered over 6 months (for example, leuprolide acetate 22.5mg IM or goserelin acetate 10.8mg SC given 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.

Sponsors & Collaborators

Principal Investigators

  • Daniel George, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-17
Primary Completion
2017-08-24
Completion
2021-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01717053 on ClinicalTrials.gov