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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

Must not have

≥ 2 years since completion of chemotherapy in the neoadjuvant or adjuvant setting

Prior bilateral orchiectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from study start to the data cutoff date, may 18, 2021, approximately 8 years, 2 months

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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It has been over 2 years since I finished my chemotherapy.

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I have had surgery to remove both testicles.

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I am currently using LHRH antagonists like Degarelix.

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I do not have severe heart problems or recent heart attacks.

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I have a history of adrenal insufficiency.

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My blood pressure is not controlled despite medication.

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I have a GI condition or had a procedure that affects how my body absorbs pills.

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I have cancer that has spread to my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from study start to the data cutoff date, may 18, 2021

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from study start to the data cutoff date, may 18, 2021

This trial's timeline: 3 weeks for screening, Varies for treatment, and from study start to the data cutoff date, may 18, 2021 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival

Secondary study objectives

Long-term Survival

Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

PSA Response Rates

+1 more

Side effects data

From 2016 Phase 1 & 2 trial • 38 Patients • NCT01084655

100%

Fatigue

75%

Alopecia

63%

Nausea

50%

Neutropenia

50%

Dysgeusia

50%

Hyperglycaemia

38%

Diarrhoea

38%

Peripheral sensory neuropathy

38%

Decreased appetite

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%

Dyspnoea

25%

Dyspepsia

25%

Pyrexia

25%

Asthenia

25%

Cough

25%

Haematuria

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%

Abdominal pain

13%

Acute kidney injury

13%

Oral candidiasis

13%

Lacrimation increased

13%

Leukopenia

13%

Dizziness

13%

Vomiting

13%

Skin infection

13%

Musculoskeletal chest pain

13%

Dry mouth

13%

Drug hypersensitivity

13%

Oedema peripheral

13%

Upper respiratory tract infection

13%

Muscular weakness

13%

Flank pain

13%

Haemorrhoids

13%

Bone pain

13%

Headache

13%

Lipase increased

13%

Pericardial effusion

13%

Diabetes mellitus

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%

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

Awards & Highlights

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.

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

0 / 13Eligibility criteria met