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Anti-Androgens and Cabazitaxel in Defining Complete Response in Prostatectomy (ACDC Trial)

NCT02543255 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-01-31

No results posted yet for this study

Summary

This study evaluates the use of chemotherapy with cabazitaxel in addition to abiraterone acetate, prednisone, and leuprolide in neoadjuvant setting prior to radical prostatectomy in patients with high-risk prostate carcinoma. Half of the participants will receive treatment with abiraterone acetate, prednisone, leuprolide, and cabazitaxel, while the other half will receive only abiraterone acetate, prednisone, and leuprolide.

Conditions

Interventions

DRUG

Abiraterone acetate with prednisone

Abiraterone acetate will be administered orally as a tablet at 1000 mg/day with prednisone (5 mg oral tablet, twice daily) for 24 weeks.

DRUG

Leuprolide

Leuprolide will be administered by subcutaneous injection at 22.5 mg dose every 12 weeks for 24 weeks.

DRUG

Cabazitaxel with peg-filgrastim

Cabazitaxel will be administered in 6 cycles, with 20 mg/m2 per cycle and 3 weeks between cycles.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Neil E Fleshner, MD, MPH, FRCSC · University Health Network, Toronto

  • Anthony Joshua, BSc (Med), MBBS, PhD, FRACP · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2021-05-27
Completion
2021-07-20

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT02543255 on ClinicalTrials.gov