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Hormone Therapy

Bicalutamide + MK2206 for Prostate Cancer

Phase 2
Waitlist Available
Led By Anna C Ferrari
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patient must have histologically confirmed diagnosis of prostate cancer
Must not have
Congestive heart failure (New York Heart Association class III or IV)
Patient must not have gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years
Awards & highlights

Summary

This trial is testing bicalutamide with or without Akt inhibitor MK2206 to see if it's effective in treating prostate cancer in patients who have been treated before.

Who is the study for?
Men with hormone-sensitive prostate cancer, who have had previous treatments like surgery or radiation, can join this trial. They should not have metastatic disease and must show a rise in PSA levels after primary therapy. Testosterone modulating therapies are not allowed within the last year unless used as neoadjuvant/adjuvant treatment.
What is being tested?
The trial is testing if bicalutamide, an antihormone therapy that reduces androgens, works better alone or combined with Akt inhibitor MK2206 which blocks enzymes needed for tumor growth. It's for men whose prostate cancer has returned after initial treatment.
What are the potential side effects?
Possible side effects include fatigue, nausea, skin rash from MK2206; and hot flashes, breast pain or enlargement from bicalutamide. The combination of both drugs may also increase these risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My prostate cancer diagnosis was confirmed through a tissue examination.
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My cancer has returned and worsened after initial treatment.
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I have had surgery, radiation, or cryoablation for my condition.
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My PSA levels rose by 2 ng/mL or more after my last radiation therapy.
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My PSA level is 0.4 ng/mL or higher after prostate surgery.
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My kidney function is normal or nearly normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe heart failure.
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I can take pills and do not have serious stomach or bowel problems.
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I am not currently on any cancer treatments or experimental drugs.
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I am not taking any drugs that affect the enzyme CYP3A4.
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My heart functions normally.
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I have been cancer-free for over 2 years after treatment for a previous cancer.
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I have congenital long QT syndrome.
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I have had episodes of very fast heartbeats.
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I am not taking medication that increases my risk of a specific heart rhythm problem.
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I have not had a heart attack or unstable chest pain in the last 6 months.
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I have a history of serious irregular heartbeats.
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I have basal or squamous cell skin cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The Proportion of Patients With Undetectable PSA Level (< 0.2 ng/mL) at 44 Weeks
Secondary study objectives
Duration of PSA Response
PSA Slope After Randomization and Before Starting Bicalutamide
PSA Slope After Starting Bicalutamide Treatment
+7 more
Other study objectives
Samples of the Primary Tumor Specimen Will be Retrieved for Banking and Future Analysis of the Molecular Profile of the Primary PC Tissues With Emphasis on the AR and Akt Upstream and Downstream Signaling Pathways.

Side effects data

From 2015 Phase 2 trial • 37 Patients • NCT01307631
30%
fatigue
19%
Rash
16%
peripheral sensory neuropathy
16%
diarrhea
14%
constipation
14%
nausea
14%
edema limbs
11%
Thromboembolic event
11%
abdominal pain
11%
hyperglycemia
8%
anorexia
8%
vomiting
8%
hypomagnesemia
8%
back pain
5%
bone pain
5%
urinary tract infections
5%
pelvic pain
5%
anemia
5%
Acute kdiney injury
5%
Hyperglycemia
3%
cough
3%
urinary frequency
3%
creatinine increased
3%
creatinine decreased
3%
pleuritic pain
3%
hematuria
3%
bruising
3%
nail discoloration
3%
weight loss
3%
hot flashes
3%
hyponatremia
3%
skin ulceration
3%
vaginal hemorrhage
3%
anxiety
3%
insomnia
3%
arthralgia
3%
Fever
3%
non-cardiac chest pain
3%
ataxia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Akt Inhibitor MK2206

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (Akt inhibitor MK2206 and bicalutamide)Experimental Treatment3 Interventions
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 Akt inhibitor MK2206 and bicalutamide until week 72 in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (observation and bicalutamide)Active Control3 Interventions
Patients undergo observation on weeks 1-12. Patients then receive bicalutamide PO 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Akt Inhibitor MK2206
2011
Completed Phase 2
~560
Bicalutamide
2003
Completed Phase 3
~5330

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,892 Total Patients Enrolled
567 Trials studying Prostate Cancer
529,809 Patients Enrolled for Prostate Cancer
Anna C FerrariPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Bicalutamide (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01251861 — Phase 2
Prostate Cancer Research Study Groups: Arm A (observation and bicalutamide), Arm B (Akt inhibitor MK2206 and bicalutamide)
Prostate Cancer Clinical Trial 2023: Bicalutamide Highlights & Side Effects. Trial Name: NCT01251861 — Phase 2
Bicalutamide (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01251861 — Phase 2
~7 spots leftby Sep 2025
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