Trial reportThe Prostate2026
Phase II Randomized Study of MK-2206 and Bicalutamide in Prostate Cancer Patients With Rising PSA After Primary Therapy (ECOG-ACRIN E2809).
Trial report in The Prostate, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01251861 (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), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
backgroundCombined inhibition of AKT and the androgen receptor (AR) might be more efficacious than AR inhibition alone in biochemical recurrence (BCR) of prostate cancer (PC) by additive effects on the two effector pathways. PATIENTS AND
methodsE2809 assigned 108 high-risk BCR patients (1:1, arm-A: arm-B) to two phases with 4-week cycles: first (PreBic) phase (3 cycles), arm-B received AKT inhibitor MK-2206 200 mg 2x/week, arm-A was observation; second phase, bicalutamide (Bic), 50 mg daily, was added to each arm. The PreBic phase assessed whether AKT inhibition changed PSA, reflecting AR activation. Exploratory primary endpoint (EP1) at 6-8 Bic cycles and secondary EP2 at cycle 14 compared the proportion of cases with ≥stable disease (SD) or progressive disease (PD).
resultsPreBic phase: 70% arm-B vs 32% arm-A patients had a ≥ 60% PSA rise (p = 0.02). MK-2206 skin toxicity (38% grade ≥ 3) drove high withdrawal prior to EP1. Bic phase: at EP1, inter-arm PSA response (81%/82%) or PD (19%/18%) was equal. At EP2, PD was greater in arm-A than arm B (36% vs 11%; p = 0.04). In subgroups defined by PreBic phase PD (PBPD; PSA rise ≥ 25%), 9/16 arm-A vs 0/7 arm-B cases experienced PD at EP2 (p = 0.02); overall between PBPD-subgroups, 73% arm-A vs 27% arm-B experienced PD.
conclusionsThe results suggest that latent improved outcome of high-risk BCR patients (mean PSA doubling time 4.4 months) on combined MK-2206+Bic versus Bic alone was attributable to a subgroup identified by crosstalk AR activation secondary to inhibition of AKT. Toxicity may affect tolerance of sustained AKT-AR inhibition. CLINICAL
trial registrationClinicalTrials. gov number, NCT01251861.
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