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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, one year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol)
Secondary outcome measures
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
+17 moreTrial 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
GnRH agonist
2016
Completed Phase 4
~3810
TAK-700
2010
Completed Phase 2
~200
Radiation therapy
2013
Completed Phase 3
~2850
Find a Location
Who is running the clinical trial?
Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
64,688 Total Patients Enrolled
32 Trials studying Prostate Cancer
20,352 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,914 Total Patients Enrolled
560 Trials studying Prostate Cancer
506,934 Patients Enrolled for Prostate Cancer
NRG OncologyOTHER
231 Previous Clinical Trials
100,613 Total Patients Enrolled
19 Trials studying Prostate Cancer
12,062 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a stomach or intestine condition that affects how I absorb pills.My recent scans show no cancer spread to distant parts of my body.My bone scan was unclear, but X-rays showed no cancer spread.I have been cancer-free or not needed cancer treatment for at least 3 years, except for non-melanoma skin cancer.I have not had a serious infection in the last 14 days.My prostate cancer has a high Gleason score but my PSA is 150 or less.My prostate cancer is aggressive with a high PSA level.My prostate cancer has a Gleason score of 7 or higher and my PSA levels are between 20-150 ng/mL.My PSA levels were checked with an approved test before starting hormone therapy.I started hormone therapy for cancer less than 50 days ago and understand I can't join the quality of life study part.I have had chemotherapy for prostate cancer before.I have had radiation therapy to my prostate area before.My kidney function is severely impaired.I have been on long-term steroids within the last year.My prostate is smaller than 60 cc, my AUA score is 15 or less, and I haven't had TURP surgery unless I'm only getting EBRT.My blood pressure has been over 150/90 despite treatment in the last 3 weeks.My recent scans or tests show no cancer in my lymph nodes.My kidney function tests are within the required range.My hemoglobin level is at least 8.0 g/dl.I don't have severe nausea, vomiting, or diarrhea that medicine can't control.I haven't had serious heart issues or strokes in the last 6 months, except stable atrial fibrillation.My prostate cancer is at high risk of coming back.I started hormone therapy for cancer less than 50 days ago and understand I can't join the quality of life study part.I have been mostly active and able to carry on all pre-disease activities without restriction recently.You are allergic to TAK-700 or similar medications.I have had surgery or treatment specifically for prostate cancer.My cancer has spread to my lymph nodes.My lymph nodes are smaller than 2.0 cm, even if their status is unclear.I have severe heart failure.I last took testosterone more than 90 days ago.My cancer has spread to other parts of my body.You have experienced an allergic reaction to the drugs used in this study before.I have a history of adrenal insufficiency.My PSA levels were checked with an approved test before starting hormone therapy.I am 18 years old or older.My liver is not functioning properly.I have not had major surgery in the last 14 days.I have been on hormonal therapy for more than 50 days.I have been diagnosed with Cushing's syndrome.I have started hormone therapy.My prostate cancer is aggressive, but my PSA is under 20 and it has grown beyond the prostate.
Research Study Groups:
This trial has the following groups:- Group 1: ADT + RT
- Group 2: TAK-700 + ADT + RT
Awards:
This trial has 2 awards, including:- 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.
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 are the common treatments that orteronel is used for?
"While most commonly used as a breast cancer treatment, orteronel has also been found to be effective at thinning the endometrium and other therapeutic procedures."
Answered by AI
Are there any other similar drug trials that orteronel has been involved in?
"orteronel was first studied in 1995 at a National Institutes of Health research facility. As of now, 323 clinical trials have been completed while 139 are still ongoing. A large number these active studies are based in Erie, Pennsylvania."
Answered by AI
Could you share if this research study is recruiting new participants?
"This study is not recruiting patients at the moment, however it was last updated on 8/11/2022. There are presently 1364 studies actively recruiting patients with prostate cancer and 139 trials for orteronel that are searching for participants."
Answered by AI
At how many locations is this research being conducted?
"The active clinical trial locations include The Regional Cancer Center in Erie, Pennsylvania; Queen's Medical Center in Honolulu, Hawaii; McLaren-Flint in Flint, Michigan and 100 other sites."
Answered by AI
How many people are being enrolled to test this new medication?
"Unfortunately, this study is no longer recruiting. The trial was posted on May 1st, 2012 and updated for the last time on August 11th, 2022. However, there are 1364 other clinical trials actively seeking patients with prostate cancer and 139 trials for orteronel that are also admitting participants."
Answered by AI
Are there any know risks associated with orteronel treatments?
"Orteronel's safety is estimated to be a 3. This assessment comes from the fact that orteronel is currently in Phase 3 clinical trials. In general, Phase 3 trials have some data suggesting efficacy and multiple rounds of data affirming safety."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
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