Ignite Creation Date:
2025-12-24 @ 12:25 PM
Ignite Modification Date:
2025-12-28 @ 11:52 AM
Study NCT ID:
NCT01251861
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2010-12-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Androgen Receptor Modulation Phase II, Randomized Study of MK-2206 - Bicalutamide Combination in Patients With Rising PSA at High-Risk of Progression After Primary Therapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
PRIMARY OBJECTIVES:
I. To compare the two regimens on the proportion of patients with undetectable prostate-specific antigen (PSA) level (\< 0.2 ng/mL) at 44 weeks.
SECONDARY OBJECTIVES:
I. To assess the proportion of patients with PSA decline \>= 85% at 44 weeks on the combination therapy arm compared to that of bicalutamide monotherapy arm.
II. To assess the distribution of best PSA response in each study arm. III. To assess the time to PSA progression in each arm of the study. IV. To assess the time to PSA nadir in each arm of the study. V. To assess the duration of PSA response in each arm of the study. VI. To characterize the PSA slope pre-study, during treatment, and off treatment.
VII. To evaluate the safety and tolerability of MK-2206 (Akt inhibitor MK2206) in this patient population.
VIII. To determine whether Gleason score has any effect on PSA response to treatment.
IX. To determine whether prior hormonal therapy has any effect on PSA response to treatment.
TERTIARY OBJECTIVES:
I. Samples of the primary tumor specimen will be retrieved for banking and future analysis of the molecular profile of the primary prostate cancer (PC) tissues with emphasis on the androgen receptor (AR) and protein kinase B (Akt) upstream and downstream signaling pathways.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients undergo observation on weeks 1-12. Patients then receive bicalutamide\* orally (PO) once daily (QD) on weeks 13-44. Patients with a PSA decline of \>= 50% may continue on bicalutamide until week 72 in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive Akt inhibitor MK2206\*\* PO once per week on weeks 1-44 and bicalutamide\* PO QD on weeks 13-44. Patients with a PSA decline of \>= 50% may continue on MK2206 and bicalutamide until week 72 in the absence of disease progression or unacceptable toxicity.
NOTE: \*Patients may begin bicalutamide on weeks 4-11 if the disease worsens.
NOTE: \*\*Patients on Akt inhibitor MK2206 with a PSA \< 0.2 ng/mL by week 12 do not receive bicalutamide until PSA rises to \>= 0.2 ng/mL.
After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every year for up to 10 years.
I. To compare the two regimens on the proportion of patients with undetectable prostate-specific antigen (PSA) level (\< 0.2 ng/mL) at 44 weeks.
SECONDARY OBJECTIVES:
I. To assess the proportion of patients with PSA decline \>= 85% at 44 weeks on the combination therapy arm compared to that of bicalutamide monotherapy arm.
II. To assess the distribution of best PSA response in each study arm. III. To assess the time to PSA progression in each arm of the study. IV. To assess the time to PSA nadir in each arm of the study. V. To assess the duration of PSA response in each arm of the study. VI. To characterize the PSA slope pre-study, during treatment, and off treatment.
VII. To evaluate the safety and tolerability of MK-2206 (Akt inhibitor MK2206) in this patient population.
VIII. To determine whether Gleason score has any effect on PSA response to treatment.
IX. To determine whether prior hormonal therapy has any effect on PSA response to treatment.
TERTIARY OBJECTIVES:
I. Samples of the primary tumor specimen will be retrieved for banking and future analysis of the molecular profile of the primary prostate cancer (PC) tissues with emphasis on the androgen receptor (AR) and protein kinase B (Akt) upstream and downstream signaling pathways.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients undergo observation on weeks 1-12. Patients then receive bicalutamide\* orally (PO) once daily (QD) on weeks 13-44. Patients with a PSA decline of \>= 50% may continue on bicalutamide until week 72 in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive Akt inhibitor MK2206\*\* PO once per week on weeks 1-44 and bicalutamide\* PO QD on weeks 13-44. Patients with a PSA decline of \>= 50% may continue on MK2206 and bicalutamide until week 72 in the absence of disease progression or unacceptable toxicity.
NOTE: \*Patients may begin bicalutamide on weeks 4-11 if the disease worsens.
NOTE: \*\*Patients on Akt inhibitor MK2206 with a PSA \< 0.2 ng/mL by week 12 do not receive bicalutamide until PSA rises to \>= 0.2 ng/mL.
After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every year for up to 10 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-02648 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| ECOG-E2809 | None | None | View | |
| CDR0000689613 | None | None | View | |
| 11-00834 | None | None | View | |
| E2809 | None | None | View | |
| E2809 | OTHER | ECOG-ACRIN Cancer Research Group | View | |
| E2809 | OTHER | CTEP | View | |
| U10CA180820 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10CA021115 | NIH | None | https://reporter.nih.gov/quic… | View |