Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01946165 · ClinicalTrials.gov registry record · Phase 2
Abiraterone Acetate Plus LHRH Agonist and Abiraterone Acetate Plus LHRH Agonist and Enzalutamide
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
NCT01946165: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01946165 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 69 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01946165, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if adding the combination of abiraterone acetate and prednisone with or without enzalutamide to hormonal therapy can help to control prostate cancer when given before surgery. The safety of the drug combination will also be studied.
Primary Outcome
The proportion of participants with pathologic stage less than or equal to ypT2N0 will be descriptively summarized and compared between the two treatment arms. The proportion will be calculated as the number of patients with less than or equal to ypT2N0 in each treatment arm divided by the total number of patients who underwent surgery in the same arm.
Interventions
- DRUG Prednisone
- DRUG Enzalutamide
- DRUG Abiraterone Acetate
- DRUG LHRHa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2013-10-31 |
| Est. Completion | 2017-07-28 |
| Phase | Phase 2 |
What the finished NCT01946165 record still lists
NCT01946165 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 4 interventions - of which Prednisone is the first listed.
NCT01946165 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01946165 about?
NCT01946165 is a clinical study titled "Abiraterone Acetate Plus LHRH Agonist and Abiraterone Acetate Plus LHRH Agonist and Enzalutamide". The goal of this clinical research study is to learn if adding the combination of abiraterone acetate and prednisone with or without enzalutamide to hormonal therapy can help to control prostate cancer when given before surgery. The safety of the drug combination will also be studied.
What is the current status of trial NCT01946165?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2013-10-31. Estimated completion is 2017-07-28.
What interventions are being tested in trial NCT01946165?
The interventions under investigation include: Prednisone (DRUG), Enzalutamide (DRUG), Abiraterone Acetate (DRUG), LHRHa (DRUG).
Who is sponsoring clinical trial NCT01946165?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01946165's enrollment target sits among peer trials
69 965th of 2000 higher than 1,034 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04020575 · 69 participants · Phase 1
Autologous huMNC2-CAR44 or huMNC2-CAR22 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*)
- NCT04163614 · 69 participants · NA
Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients
- NCT04164641 · 69 participants · NA
Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic Gait Correction in Reducing Diabetic Foot Ulceration Or Subsequent Amputation in Patients With a History of a Diabetic Foot Ulceration
- NCT04493372 · 69 participants · NA
Deciphering Preserved Autonomic Function After Spinal Cord Injury
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI