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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years

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

anorexia

vomiting

hypomagnesemia

back pain

bone pain

urinary tract infections

pelvic pain

anemia

Acute kdiney injury

Hyperglycemia

pleuritic pain

creatinine decreased

cough

urinary frequency

creatinine increased

hematuria

bruising

nail discoloration

weight loss

hot flashes

hyponatremia

skin ulceration

vaginal hemorrhage

anxiety

insomnia

arthralgia

Fever

non-cardiac chest pain

ataxia

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Akt Inhibitor MK2206

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~6210