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Anti-androgen

Hormone + Radiation Therapy with TAK-700 for Prostate Cancer

Phase 3

Waitlist Available

Led By M. Dror Michaelson, MD, PhD

Research Sponsored by Radiation Therapy Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Gleason Score (GS) ≥ 9, PSA ≤ 150 ng/mL, any T stage

GS ≥ 8, PSA ≥ 20-150 ng/mL, any T stage

Must not have

Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-700, including difficulty swallowing tablets

Serious infection within 14 days prior to registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, one year

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is studying the use of hormone therapy, including TAK-700, together with radiation therapy to see how well it works in treating patients with prostate cancer.

Who is the study for?

Men aged 18+ with high-risk prostate cancer, who may have started hormone therapy within the last 50 days but haven't had certain treatments like chemotherapy for prostate cancer. They should not have other active cancers or serious heart, liver, or kidney diseases and must be willing to use contraception.

What is being tested?

This phase III trial is testing if adding TAK-700 to standard hormone therapy and radiation helps treat high-risk prostate cancer better. It also looks at how these treatments affect patients' quality of life over time.

What are the potential side effects?

Possible side effects include hot flashes, fatigue, sexual dysfunction, urinary issues due to hormone therapy; skin irritation from radiation; and increased risk of cardiovascular problems with TAK-700.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer has a high Gleason score but my PSA is 150 or less.

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My prostate cancer is aggressive with a high PSA level.

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My prostate cancer has a Gleason score of 7 or higher and my PSA levels are between 20-150 ng/mL.

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I have been mostly active and able to carry on all pre-disease activities without restriction recently.

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I am 18 years old or older.

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My prostate cancer is aggressive, but my PSA is under 20 and it has grown beyond the prostate.

Exclusion Criteria

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

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I have a stomach or intestine condition that affects how I absorb pills.

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I have not had a serious infection in the last 14 days.

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I have had chemotherapy for prostate cancer before.

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I have had radiation therapy to my prostate area before.

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My kidney function is severely impaired.

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I have been on long-term steroids within the last year.

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I don't have severe nausea, vomiting, or diarrhea that medicine can't control.

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I haven't had serious heart issues or strokes in the last 6 months, except stable atrial fibrillation.

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My blood pressure has been over 150/90 despite treatment in the last 3 weeks.

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I have had surgery or treatment specifically for prostate cancer.

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My cancer has spread to my lymph nodes.

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I have severe heart failure.

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My cancer has spread to other parts of my body.

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I have a history of adrenal insufficiency.

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My liver is not functioning properly.

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I have not had major surgery in the last 14 days.

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I have been on hormonal therapy for more than 50 days.

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I have been diagnosed with Cushing's syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and yearly to five years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and yearly to five years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and yearly to five 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

Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol)

Secondary study objectives

Change From Baseline in Body Mass Index (BMI)

Change in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form at One Year

Change in Patient-reported Quality of Life as Measured by Expanded Prostate Cancer Index Composite (EPIC) Short Form at One Year

+10 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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: TAK-700 + ADT + RTExperimental Treatment4 Interventions

TAK-700 and standard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT. TAK-700 continues for two years.

Group II: ADT + RTActive Control3 Interventions

Standard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation therapy

2013

Completed Phase 3

~2850

GnRH agonist

2016

Completed Phase 4

~3810