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NCT01251861 · ClinicalTrials.gov registry record · Phase 2
Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer
A Phase 2 study of Recurrent Prostate Carcinoma and Stage III Prostate Cancer AJCC v7, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 108
- Enrollment target
- 20
- Study locations
NCT01251861: Active Phase 2 study of Recurrent Prostate Carcinoma and Stage III Prostate Cancer AJCC v7, sponsored by National Cancer Institute (NCI).
NCT01251861 is a Phase 2 study of Recurrent Prostate Carcinoma and Stage III Prostate Cancer AJCC v7 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 108 participants, below the 162-participant average among 29 other Recurrent Prostate Carcinoma trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01251861, a Phase 2 study of Recurrent Prostate Carcinoma and Stage III Prostate Cancer AJCC v7, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 108 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well giving bicalutamide with or without Akt inhibitor MK2206 works in treating patients with previously treated prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether bicalutamide is more effective with or without Akt inhibitor MK2206 in treating prostate cancer.
Primary Outcome
The proportion of patients with undetectable PSA level (\< 0.2 ng/mL) at 44 weeks, defined as number of patients with undetectable PSA level at 44 weeks divided by number of patients randomized.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Clinical Observation
- DRUG Bicalutamide
- DRUG Akt Inhibitor MK2206
Study Locations (20)
Colorado
- The Medical Center of Aurora - Aurora
- Boulder Community Foothills Hospital - Boulder
- Penrose-Saint Francis Healthcare - Colorado Springs
- AdventHealth Porter - Denver
- Presbyterian - Saint Lukes Medical Center - Health One - Denver
- Saint Joseph Hospital - Cancer Centers of Colorado - Denver
- Rose Medical Center - Denver
- Western States Cancer Research NCORP - Denver
- Swedish Medical Center - Englewood
- Poudre Valley Hospital - Fort Collins
- Saint Mary's Hospital and Regional Medical Center - Grand Junction
- Banner North Colorado Medical Center - Greeley
- Saint Anthony Hospital - Lakewood
- AdventHealth Littleton - Littleton
- Sky Ridge Medical Center - Lone Tree
- Longmont United Hospital - Longmont
- Banner North Colorado Medical Center - Loveland Campus - Loveland
- AdventHealth Parker - Parker
California
- Stanford Cancer Institute Palo Alto - Palo Alto
- VA Palo Alto Health Care System - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2010-12-23 |
| Est. Completion | 2026-03-18 |
| Phase | Phase 2 |
What the registry record for NCT01251861 still lists
NCT01251861 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 162-participant average among 29 other Recurrent Prostate Carcinoma trials with a reported enrollment target (33% lower).
The record links to 5 conditions, with Recurrent Prostate Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01251861 names 20 study sites across 2 states, led by Colorado, California.
Frequently Asked Questions
What is clinical trial NCT01251861 about?
NCT01251861 is a clinical study titled "Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer". This phase II trial studies how well giving bicalutamide with or without Akt inhibitor MK2206 works in treating patients with previously treated prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens mad...
What is the current status of trial NCT01251861?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2010-12-23. Estimated completion is 2026-03-18.
What conditions does trial NCT01251861 study?
This clinical trial studies the following conditions: Recurrent Prostate Carcinoma, Stage III Prostate Cancer AJCC v7, Stage IIB Prostate Cancer AJCC v7, Stage I Prostate Cancer AJCC v7, Stage IIA Prostate Cancer AJCC v7.
What interventions are being tested in trial NCT01251861?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Clinical Observation (OTHER), Bicalutamide (DRUG), Akt Inhibitor MK2206 (DRUG).
Who is sponsoring clinical trial NCT01251861?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01251861 being conducted?
This trial has 20 study locations across California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Prostate Carcinoma
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 NCT01251861's enrollment target sits among peer trials
108 8th of 29 higher than 22 of 29 other Recurrent Prostate Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Prostate Carcinoma 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.
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