Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03706365 · ClinicalTrials.gov registry record · Phase 2
A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
A Phase 2 study of Prostate Cancer, sponsored by Eli Lilly and Company.
- Active
- Registry status
- Phase 2
- Development phase
- 393
- Enrollment target
- 20
- Study locations
NCT03706365: Active Phase 2 study of Prostate Cancer, sponsored by Eli Lilly and Company.
NCT03706365 is a Phase 2 study of Prostate Cancer that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 393 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (35% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03706365, a Phase 2 study of Prostate Cancer, is active but no longer recruiting, sponsored by Eli Lilly and Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 393 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer. Prednisolone may be used instead of prednisone per local regulation.
Primary Outcome
The rPFS time is measured from the date of randomization to the earliest date of investigator determined radiographic disease progression (by objective radiographic disease assessment per response evaluation criteria in solid tumors (RECIST) version 1.1 for soft tissue AND/OR radionuclide bone scan using prostate cancer working group 3 -PCWG3 criteria for bone) or death from any cause, whichever occurs first.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Abemaciclib
- DRUG Prednisone
- DRUG Abiraterone acetate
Study Locations (20)
California
- CBCC Global Research, Inc. - Bakersfield
- Providence St. Jude Medical Center - Fullerton
- Moores Cancer Center - La Jolla
- TRIO-US (Translational Research in Oncology-US) - Los Angeles
- UCLA Hematology/Oncology - Westwood (Building 100) - Los Angeles
- Pacific Cancer Care - Monterey
- Sansum Clinic_Kendle - Santa Barbara
Arizona
- St. Joseph's Hospital and Medical Center - Phoenix
- Mayo Clinic in Arizona - Phoenix - Phoenix
- The University of Arizona Cancer Center - North Campus - Tucson
New York
- New York Oncology Hematology (NYOH) - Clifton Park Cancer Center - Albany
- Associated Medical Professionals - Urology - Syracuse
Arkansas
- St. Bernards Medical Center - Jonesboro
Colorado
- Rocky Mountain Cancer Center - Lone Tree
Florida
- Millennium Oncology - Hollywood - Hollywood
Georgia
- Northside Hospital - Atlanta
Indiana
- Fort Wayne Medical Oncology And Hematology at Parkview Comprehensive Cancer Center - Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 393 participants |
| Start Date | 2018-11-26 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What the registry record for NCT03706365 still lists
NCT03706365 is an interventional study that assigns participants to a tested intervention. The registered 393 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (35% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT03706365 names 20 study sites across 11 states, led by California, Arizona, New York.
Frequently Asked Questions
What is clinical trial NCT03706365 about?
NCT03706365 is a clinical study titled "A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer". This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer. Prednisolone may be used instead of prednisone per local regulation.
What is the current status of trial NCT03706365?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 393 participants. The study started on 2018-11-26. Estimated completion is 2026-06.
What conditions does trial NCT03706365 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT03706365?
The interventions under investigation include: Placebo (DRUG), Abemaciclib (DRUG), Prednisone (DRUG), Abiraterone acetate (DRUG).
Who is sponsoring clinical trial NCT03706365?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03706365 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03706365's enrollment target sits among peer trials
393 134th of 735 higher than 602 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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
-
Trial of Neoadjuvant Enoblituzumab vs SOC in Men With High-Risk Localized Prostate Cancer
RECRUITING · Phase 2
-
Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer
RECRUITING · Phase 2
-
Post-prostatectomy Radiation Therapy--Moderate Versus Ultra-hypofractionated (Also Known as Stereotactic Body Radiation Therapy [SBRT])
RECRUITING · Phase 2
-
A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
RECRUITING · Phase 2
-
Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging
RECRUITING · Phase 2
-
High Intensity Focused Ultrasound in Prostate Cancer
RECRUITING · Phase 2
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
- NCT05640999 · 393 participants · Phase 2
Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
- NCT06613698 · 393 participants · Phase 2
A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 65 Years With Alcohol-related Liver Disease
- NCT06657924 · 394 participants · Phase 2
Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery
- NCT07225660 · 394 participants · NA
Hormonal Optimization: Late vs. Immediate Start After Discontinuation of Oral Contraceptives in Assisted Reproductive technologY (HOLIDAY)
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