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Antiandrogen
TAK-700 vs. Bicalutamide for Prostate Cancer (S1216 Trial)
Phase 3
Waitlist Available
Led By Neeraj Agarwal, M.D.
Research Sponsored by Southwest Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate hepatic function as evidenced by bilirubin ≤ 2 x institutional upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) ≤ 3 x institutional ULN, or ≤ 5 x institutional ULN if liver metastases are present
Adequate renal function as evidenced by calculated creatinine clearance ≥ 40 mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study start to the data cutoff date, may 18, 2021
Awards & highlights
S1216 Trial Summary
This trial is testing if a new drug called TAK-700 helps people with prostate cancer live longer than another drug called bicalutamide when used with ADT.
Who is the study for?
This trial is for men with newly diagnosed metastatic prostate cancer who have a good performance status, meaning they can carry out daily activities with little to no assistance. They must have adequate liver, heart, and kidney function, agree to use contraception if of reproductive potential, and not have any serious illnesses that could interfere with the study. Men previously treated for other cancers may be eligible if they are in remission.Check my eligibility
What is being tested?
The study aims to compare the effectiveness of two treatments on overall survival rates: one group will receive TAK-700 plus standard hormone therapy (ADT), while another group will get bicalutamide along with ADT. Participants are randomly assigned to either treatment path.See study design
What are the potential side effects?
Potential side effects include gastrointestinal issues due to oral medication absorption problems; allergic reactions to TAK-700 or bicalutamide; increased risk of cardiac events like heart attacks or arrhythmias; blood pressure changes; and hormonal side effects such as hot flashes.
S1216 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver function tests are within the required limits.
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My kidneys are working well enough (creatinine clearance ≥ 40 mL/min).
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I am 18 years old or older.
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My prostate cancer has spread to other parts of my body.
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My PSA level was 2 ng/mL or higher before starting hormone therapy.
S1216 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from study start to the data cutoff date, may 18, 2021, approximately 8 years, 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study start to the data cutoff date, may 18, 2021, approximately 8 years, 2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Secondary outcome measures
Long-term Survival
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
PSA Response Rates
+1 moreSide effects data
From 2016 Phase 1 & 2 trial • 38 Patients • NCT01084655100%
Fatigue
75%
Alopecia
63%
Nausea
50%
Neutropenia
50%
Hyperglycaemia
50%
Dysgeusia
38%
Peripheral sensory neuropathy
38%
Decreased appetite
38%
Diarrhoea
38%
Weight decreased
38%
White blood cell count decreased
38%
Muscle spasms
38%
Myalgia
38%
Hyperkalaemia
38%
Hypophosphataemia
25%
Flushing
25%
Abdominal pain upper
25%
Cough
25%
Dyspepsia
25%
Haematuria
25%
Dyspnoea
25%
Pyrexia
25%
Asthenia
25%
Hypoaesthesia
25%
Insomnia
25%
Nocturia
25%
Dyspnoea exertional
25%
Dehydration
25%
Abdominal discomfort
25%
Neutrophil count decreased
25%
Hypertension
25%
Constipation
25%
Hypomagnesaemia
13%
Acute kidney injury
13%
Haemorrhoids
13%
Vomiting
13%
Dry mouth
13%
Drug hypersensitivity
13%
Skin infection
13%
Oral candidiasis
13%
Musculoskeletal chest pain
13%
Muscular weakness
13%
Lipase increased
13%
Diabetes mellitus
13%
Leukopenia
13%
Oedema peripheral
13%
Dizziness
13%
Lacrimation increased
13%
Headache
13%
Abdominal pain
13%
Flank pain
13%
Pericardial effusion
13%
Bone pain
13%
Upper respiratory tract infection
13%
Pneumonitis
13%
Hot flush
13%
Amylase increased
13%
Paraesthesia
13%
Restless legs syndrome
13%
Pneumonia
13%
Febrile neutropenia
13%
Anxiety
13%
Depression
13%
Epistaxis
13%
Hyperhidrosis
13%
Flatulence
13%
Chills
13%
Pain
13%
Fall
13%
Blood bilirubin increased
13%
Back pain
13%
Rash macular
13%
Hypotension
13%
Ejection fraction decreased
13%
Hyponatraemia
13%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone
Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone
Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone
S1216 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ADT + TAK-700Experimental Treatment1 Intervention
LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
TAK-700, 300 mg, PO, twice daily
Group II: ADT + BicalutamideActive Control1 Intervention
LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
Bicalutamide, 50 mg, PO, q daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Orteronel
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
260,498 Total Patients Enrolled
26 Trials studying Prostate Cancer
52,237 Patients Enrolled for Prostate Cancer
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
263,857 Total Patients Enrolled
26 Trials studying Prostate Cancer
52,237 Patients Enrolled for Prostate Cancer
Millennium Pharmaceuticals, Inc.Industry Sponsor
404 Previous Clinical Trials
45,601 Total Patients Enrolled
17 Trials studying Prostate Cancer
3,370 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.It has been over 30 days since my last hormone therapy for prostate cancer.I am currently using LHRH antagonists like Degarelix.I do not have severe heart problems or recent heart attacks.I have a history of adrenal insufficiency.I am willing to change my current antiandrogen treatment if required.My blood pressure is not controlled despite medication.I have a GI condition or had a procedure that affects how my body absorbs pills.I have no cancer history except for certain skin cancers, early-stage cancers in remission, or any cancer I've been free from for 5 years.My prostate cancer has spread to other parts of my body.My PSA level was 2 ng/mL or higher before starting hormone therapy.I can take care of myself, but I might not be able to do heavy physical work. If I'm less active, it's only because of bone pain.It has been over 6 months since I finished hormone therapy for cancer.I have had chemotherapy for prostate cancer that has spread.I have had surgery to remove both testicles.My liver function tests are within the required limits.My kidneys are working well enough (creatinine clearance ≥ 40 mL/min).I have taken or am taking ketoconazole, aminoglutethimide, abiraterone acetate, or enzalutamide.It has been over 2 years since I finished my chemotherapy.I am on LHRH for prostate cancer and open to adding more treatments.I am a man who will use contraception or abstain from sex during and for 4 months after the study.I can take care of myself, but I might not be able to do heavy physical work. If I'm less active, it's only because of bone pain.I have had hormone therapy for cancer for no more than 36 months.I do not have HIV, hepatitis B or C, or any severe illness that could affect my study participation.I have cancer that has spread to my brain.
Research Study Groups:
This trial has the following groups:- Group 1: ADT + TAK-700
- Group 2: ADT + Bicalutamide
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 other scientific research has looked at TAK-700?
"Right now, there are 3,664 locations around the world where TAK-700 is being studied in clinical trials. Of those active studies, 15 are in Phase 3."
Answered by AI
TAK-700 has been found to be very effective in people, but are there any safety concerns that patients should know about?
"TAK-700 has been studied in Phase 3 trials, which means that while there is data supporting its efficacy, there are also multiple rounds of data affirming its safety. As such, our team at Power gave it a score of 3."
Answered by AI
What are the most important goals of this research project?
"The primary outcome that will be measured over a 3.2 year interval is Overall Survival, according to the clinical trial sponsor, Millennium Pharmaceuticals, Inc. Additionally, this study will measure secondary outcomes including PSA Response Rates and Progression Free Survival. PSA Response Rates are defined as the Prostate-specific antigen (PSA) response rates divided into complete response (CR: PSA < 0.2 ng/mL), partial response (PR: PSA between 0.2 and 4.0 ng/mL), and no response (NR: PSA > 4.0 ng/mL) at a 7-month"
Answered by AI
What makes this clinical trial innovative?
"TAK-700 has undergone 36 clinical trials in 841 cities across 27 countries. The first trial occurred in 2000 and was sponsored by AstraZeneca. This initial study included 600 patients and completed Phase 3 drug approval. As of now, a total of 82 studies have been completed since the year 2000."
Answered by AI
Are people still able to join this clinical trial?
"The clinical trial mentioned is not presently looking for patients. The date the trial was last updated was 8/16/2022, and it was initially posted on 3/1/2013. Although this particular study has closed recruitment, there are 1400 other trials that are searching for patients right now."
Answered by AI
How many people are being signed up for this clinical trial?
"No longer active, this study was last updated on 8/16/2022. If you are interested in other prostate cancer trials, there are currently 1364 admitting patients and 36 for TAK-700."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
How old are they?
65+
What site did they apply to?
Southern Arizona Veterans Affairs Health Center
What portion of applicants met pre-screening criteria?
Met criteria
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