Your session is about to expire
← Back to Search
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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My prostate cancer diagnosis was confirmed through a tissue examination.
Select...
My cancer has returned and worsened after initial treatment.
Select...
I have had surgery, radiation, or cryoablation for my condition.
Select...
My PSA levels rose by 2 ng/mL or more after my last radiation therapy.
Select...
My PSA level is 0.4 ng/mL or higher after prostate surgery.
Select...
My kidney function is normal or nearly normal.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Proportion of Patients With Undetectable PSA Level (< 0.2 ng/mL) at 44 Weeks
Secondary outcome measures
Duration of PSA Response
PSA Slope After Randomization and Before Starting Bicalutamide
PSA Slope After Starting Bicalutamide Treatment
+7 moreOther outcome measures
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 • NCT0130763130%
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%
pleuritic pain
3%
creatinine decreased
3%
creatinine increased
3%
hematuria
3%
urinary frequency
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
13,654 Previous Clinical Trials
40,933,045 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
Anna C FerrariPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My PSA levels are between 2 and 50 ng/mL and stable or increasing.I have severe heart failure.I can take pills and do not have serious stomach or bowel problems.I am fully active or restricted in physically strenuous activity but can do light work.I stopped taking certain seizure medications 14 days before joining the study.I've had treatment for my cancer within the last 4 weeks, and my PSA levels increased after treatment when my testosterone was normal.I am not currently on any cancer treatments or experimental drugs.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am not taking any drugs that affect the enzyme CYP3A4.My heart functions normally.I do not have any other cancer besides the one being treated, or it meets certain exceptions.I have been cancer-free for over 2 years after treatment for a previous cancer.I have congenital long QT syndrome.I have had episodes of very fast heartbeats.I am not taking medication that increases my risk of a specific heart rhythm problem.I have not had a heart attack or unstable chest pain in the last 6 months.I have no allergies to MK-2206, bicalutamide, or similar drugs.I have a history of serious irregular heartbeats.I have basal or squamous cell skin cancer.I am not taking certain medications or consuming grapefruit.My prostate cancer diagnosis was confirmed through a tissue examination.I stopped any targeted cancer treatments at least 4 weeks ago and had no severe side effects from them.My prostate cancer responds to hormones, with a testosterone level over 150 ng/dL.My PSA level is 0.4 ng/mL or higher after prostate surgery.My kidney function is normal or nearly normal.I am not on blood thinners, but I may be taking low-dose aspirin.My PSA levels have increased after initial prostate cancer treatment.I have diabetes or a high blood sugar risk, but it is well controlled.I haven't taken any medication that affects testosterone levels in the past year.I've had treatment aimed at curing my cancer within the last 4 weeks.My cancer has returned and worsened after initial treatment.I have had surgery, radiation, or cryoablation for my condition.My recent scans show no signs of cancer spread.My PSA levels rose by 2 ng/mL or more after my last radiation therapy.My second PSA level was higher than the first, measured at least 2 weeks apart and within 6 months before joining the study.My heart's electrical activity (QTc interval) is within a safe range.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (observation and bicalutamide)
- Group 2: Arm B (Akt inhibitor MK2206 and bicalutamide)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the intake capacity for this trial?
"This clinical trial has since concluded its recruitment period, having first been posted on December 23rd 2010 and last edited on October 15th 2022. If interested in other trials, there are 1247 studies recruiting patients with malignant neoplasm of the prostate as well as 34 for Akt Inhibitor MK2206."
Answered by AI
How widely distributed is this research within the United States?
"Patients are being enrolled for this study at a variety of locations, such as Memorial Hospital of South Bend in Indiana, Miller-Dwan Hospital in Minnesota, and the Saint Vincent Hospital Cancer Center Green Bay in Wisconsin."
Answered by AI
Is this particular clinical trial unprecedented in its design and scope?
"Akt Inhibitor MK2206 has been subject to 34 live studies involving 27 nations and 849 towns. The inception of these trials was in 2000, when 600 participants were recruited for an AstraZeneca-sponsored endeavour that ultimately achieved Phase 3 drug approval status. Since then, 644 additional examinations have concluded successfully."
Answered by AI
Is there availability for enrolment in this research project?
"According to clinicaltrials.gov, this study has not been actively seeking patients since October 15th 2022, when the posting was last updated. However, there are currently 1281 other trials that require participants at present."
Answered by AI
What evidence exists to suggest the safety of MK2206 Akt Inhibitor for human use?
"Our team at Power gave Akt Inhibitor MK2206 a score of 2, as this is only on Phase 2 trials. It has some evidence backing its safety but none that can be used to assess efficacy."
Answered by AI
What additional research has been done in regards to the efficacy of Akt Inhibitor MK2206?
"Initially studied at Centre de Recherche Clinique du CHUS in the year 2000, Akt Inhibitor MK2206 has been subject to 644 completed clinical trials and currently boasts 34 active ones. Many of these are taking place in South Bend, Indiana."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger