A Phase 3 interventional study of GnRH agonist and Anti-androgen in Prostate Cancer, sponsored by Radiation Therapy Oncology Group. Completed at 172 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Radiation Therapy Oncology Group · Phase 3, Interventional, and Treatment
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as steroid 17alpha-monooxygenase TAK-700, when used with other hormone therapy, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for prostate cancer when combined with hormone therapy. Studying quality-of-life in patients having cancer treatment may help identify the intermediate- and long-term effects of treatment on patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying the use of hormone therapy, including TAK-700, together with radiation therapy in treating patients with prostate cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to risk group (see Disease Characteristics) and type of radiation therapy (RT) boost (intensity-modulated RT (IMRT) vs brachytherapy). Patients are randomized to 1 of 2 treatment arms.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 239 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Radiation Therapy Oncology Group is the lead sponsor of 155 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
confirmed diagnosis of adenocarcinoma of the prostate within 180 days prior to registration at high risk for recurrence as determined by one of the following combinations:
Clinically negative lymph nodes as established by imaging [abdominal and/or pelvic computerized tomography (CT) or abdominal and/or pelvic magnetic resonance imaging (MRI)], nodal sampling, or dissection within 90 days prior to registration.
•Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are \< 2.0 cm.
No distant (M0) on bone scan within 90 days prior to registration (18F-Na bone scan is an acceptable substitute).
•Equivocal bone scan findings are allowed if plain films are negative for metastasis.
Complete blood count (CBC)/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows:
Patients, even if surgically sterilized (ie, status post vasectomy), who:
Exclusion Criteria:
Prior radiotherapy, including brachytherapy, to the region of the prostate that would result in overlap of radiation therapy fields.
•Any patient undergoing brachytherapy must have transrectal ultrasound confirmation of prostate volume \<60 cc, American Urological Association (AUA) score ≤15 within 60 days of registration, and no history of prior transurethral resection of the prostate (TURP); prior TURP is permitted for patients who receive external beam radiation therapy [EBRT] only).
abnormalities of:
Study entry PSA obtained during the following time frames:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: GnRH agonist · Drug: Anti-androgen · Radiation: Radiation therapy
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.
Drug: GnRH agonist · Drug: Anti-androgen · Drug: TAK-700 · Radiation: Radiation therapy
LHRH agonists are administered with a variety of techniques. The manufacturer's instructions should be followed. Begins within 6 weeks after registration (if not started prior) at same time as anti-androgen and TAK-700 (if applicable).
Also known as: LHRH analog, leuprolide, goserelin, buserelin, triptorelin, Gonadotropin-releasing hormone (GnRH) Agonist, LHRH agonist
Starts at same time as GnRH agonist, ends at end of radiation therapy. Either flutamide (orally 250 mg three times a day) or bicalutamide (orally 50 mg once a day).
Also known as: flutamide, bicalutamide, androgen suppression
300 mg twice daily (BID) (600 mg per day) orally, continuously for 2 years starting with ADT.
Starts 8-10 weeks after initiation of ADT. Initially 45 Gy (1.8 Gy / fraction) to prostate and pelvic lymph nodes delivered with 3DCRT/IMRT, then a boost using intensity-modulated radiation therapy (IMRT), low dose rate (LDR) brachytherapy, or high dose rate (HDR) brachytherapy.
Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol)
Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from secondary (original protocol) to primary. Biochemical failure will be defined by the Phoenix definition (PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or the initiation of salvage androgen deprivation therapy. Time to failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here.
Time frame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
Percentage of Patients Alive [Overall Survival] (Primary Endpoint of Original Protocol)
Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from primary (original protocol) to secondary. Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. 5-year rates are provided.
Time frame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
Percentage of Participants With Grade 3 or Higher Adverse Events
Time to grade 3 or higher adverse event (event) is defined as time from randomization to the date of first event, last known follow-up (censored), or death without failure (competing risk). Event rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here.
Time frame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
Percentage of Participants With Local Progression
Local recurrence (failure) is defined as biopsy proven recurrence within the prostate gland. Time to failure is defined as time from randomization to the date of failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here.
Time frame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates reported.
Percentage of Participants With Distant Metastases
Distant metastases (failure) is defined as imaging or biopsy demonstrated evidence for systemic recurrence. Biopsy was not required, however it was encouraged in absence of a rising PSA. Time to failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here. Note, the protocol lists this endpoint as regional or distant metastasis, but regional progression data was not collected.
Time frame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
Percentage of Participants With General Clinical Treatment Failure
General clinical treatment failure (GCTF) is defined as: PSA \> 25 ng/ml, documented local disease progression, regional or distant metastasis, or initiation of salvage androgen deprivation therapy. Failure time is defined as time from registration to the date of failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here.
Time frame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
Percentage of Participants With Death Due to Prostate Cancer
Time to prostate cancer death is defined as time from randomization to the date of death due to prostate cancer, last known follow-up (censored), or death due to other causes (competing risk). Failure rates were to be estimated using the cumulative incidence method. If too few events occur for meaningful estimates, then only counts of events will be reported.
Time frame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
Change in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form at One Year
The PROMIS Fatigue short form 8a contains 8 questions, each with 5 responses ranging from 1 to 5, evaluating self-reported fatigue symptoms over the past 7 days. The total score is the sum of all questions which is then converted into a pro-rated T-score with a mean of 50 and standard deviation of 10, with a possible range of 33.1 to 77.8. Higher scores indicate more fatigue. Change is defined as value at one year - value at baseline. Positive change from baseline indicates increased fatigue at one year.
Time frame: Baseline, one year
Change in Patient-reported Quality of Life as Measured by Expanded Prostate Cancer Index Composite (EPIC) Short Form at One Year
The EPIC-Short Form is a 26-item, validated self-administered tool to assess disease-specific aspects of prostate cancer and its therapies consisting of five summary domains (bowel, urinary incontinence, urinary irritation/obstruction, sexual, and hormonal function). Responses for each item form a Likert scale which are transformed to a 0-100 scale. A domain score is the average of the transformed domain item scores, ranging from 0-100 with higher scores representing better health-related quality of life (HRQOL). Change at one year is defined as one-year value - baseline value. Positive change at one year indicates improved quality of life.
Time frame: Baseline, one year
Serum Testosterone
Time frame: Baseline,12 months, 24 months
Fasting Total Cholesterol
Time frame: Baseline, 12 months, 24 months
Serum High-density Lipoprotein (HDL)
Time frame: Baseline, 12 months, 24 months
Serum High-density Lipoprotein (LDL)
Time frame: Baseline, 12 months, 24 months
Hemoglobin A1c
Time frame: Baseline, 12 months, 24 months
Fasting Plasma Glucose
Time frame: Baseline, 12 months, 24 months
Fasting Plasma Insulin
Time frame: Baseline, 12 months, 24 months
Change From Baseline in Body Mass Index (BMI)
Body Mass Index (BMI) is a person's weight in kilograms (or pounds) divided by the square of height in meters (or feet). Change from baseline = time point value - baseline value.
Time frame: Baseline and yearly to five years.
Number of Participants by Highest Grade Adverse Event
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data
Time frame: From registration to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
Testosterone Recovery at 12 and 24 Months
Testosterone recovery is defined as testosterone level after treatment greater than 230 ng/dL. Time to testosterone recovery is defined as time from randomization to the date of testosterone recovery, biochemical, local, or distant failure (competing risk), salvage therapy (competing risk), death (competing risk), or last known follow-up (censored). Testosterone recovery rates are estimated using the cumulative incidence method.
Time frame: From registration to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years.
Median Testosterone Recovery Time
Testosterone recovery is defined as testosterone level after treatment greater than 230 ng/dL. Testosterone recovery rates are estimated using the Kaplan-Meier method, censoring for biochemical, local, or distant failure, salvage therapy, death, and otherwise alive without event. Testosterone recovery time is defined as time from randomization to testosterone recovery or censoring.
Time frame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
Number of Patients With Clinical Survivorship Events
Clinical survivorship events are defined as the following newly diagnosed non-fatal cardiovascular events or other clinical endpoints relevant to prostate cancer survivorship: type 2 diabetes, coronary artery disease, myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis, and osteoporotic fracture.
Time frame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol) by Ethnicity
Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from secondary (original protocol) to primary. Biochemical failure will be defined by the Phoenix definition (PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or the initiation of salvage androgen deprivation therapy. Time to failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here.
Time frame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol) by Race
Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from secondary (original protocol) to primary. Biochemical failure will be defined by the Phoenix definition (PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or the initiation of salvage androgen deprivation therapy. Time to failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here.
Time frame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.
| Milestone | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Started | 118 | 120 |
| Eligible | 115 | 116 |
| Eligible participants who consented to quality of life (qol) component | 103 | 94 |
| Completed | 115 | 116 |
| Not completed | 3 | 4 |
| Withdrew: Protocol violation | 3 | 4 |
Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from secondary (original protocol) to primary. Biochemical failure will be defined by the Phoenix definition (PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or the initiation of salvage androgen deprivation therapy. Time to failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here.
| percentage of participants | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol) | 17.3 (10.7 to 25.2) | 12.8 (7.1 to 20.1) |
Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from primary (original protocol) to secondary. Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. 5-year rates are provided.
| percentage of participants | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Percentage of Patients Alive [Overall Survival] (Primary Endpoint of Original Protocol) | 89.4 (83.5 to 95.3) | 88.1 (81.8 to 94.4) |
Time to grade 3 or higher adverse event (event) is defined as time from randomization to the date of first event, last known follow-up (censored), or death without failure (competing risk). Event rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here.
| percentage of participants | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Percentage of Participants With Grade 3 or Higher Adverse Events | 34.9 (26.0 to 43.9) | 58.9 (48.8 to 67.6) |
Local recurrence (failure) is defined as biopsy proven recurrence within the prostate gland. Time to failure is defined as time from randomization to the date of failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here.
| percentage of participants | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Percentage of Participants With Local Progression | 2.9 (0.8 to 7.6) | 0.0 (0.0 to 0.0) |
Distant metastases (failure) is defined as imaging or biopsy demonstrated evidence for systemic recurrence. Biopsy was not required, however it was encouraged in absence of a rising PSA. Time to failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here. Note, the protocol lists this endpoint as regional or distant metastasis, but regional progression data was not collected.
| percentage of participants | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Percentage of Participants With Distant Metastases | 6.8 (3.0 to 12.7) | 2.9 (0.8 to 7.7) |
General clinical treatment failure (GCTF) is defined as: PSA \> 25 ng/ml, documented local disease progression, regional or distant metastasis, or initiation of salvage androgen deprivation therapy. Failure time is defined as time from registration to the date of failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here.
| percentage of participants | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Percentage of Participants With General Clinical Treatment Failure | 12.5 (7.0 to 19.6) | 6.8 (3.0 to 12.8) |
Time to prostate cancer death is defined as time from randomization to the date of death due to prostate cancer, last known follow-up (censored), or death due to other causes (competing risk). Failure rates were to be estimated using the cumulative incidence method. If too few events occur for meaningful estimates, then only counts of events will be reported.
| percentage of participants | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Percentage of Participants With Death Due to Prostate Cancer | 7.7 (3.6 to 13.9) | 4.9 (1.8 to 10.5) |
The PROMIS Fatigue short form 8a contains 8 questions, each with 5 responses ranging from 1 to 5, evaluating self-reported fatigue symptoms over the past 7 days. The total score is the sum of all questions which is then converted into a pro-rated T-score with a mean of 50 and standard deviation of 10, with a possible range of 33.1 to 77.8. Higher scores indicate more fatigue. Change is defined as value at one year - value at baseline. Positive change from baseline indicates increased fatigue at one year.
| T-score | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Change in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form at One Year | 2.78 ± 7.21 | 3.16 ± 8.24 |
The EPIC-Short Form is a 26-item, validated self-administered tool to assess disease-specific aspects of prostate cancer and its therapies consisting of five summary domains (bowel, urinary incontinence, urinary irritation/obstruction, sexual, and hormonal function). Responses for each item form a Likert scale which are transformed to a 0-100 scale. A domain score is the average of the transformed domain item scores, ranging from 0-100 with higher scores representing better health-related quality of life (HRQOL). Change at one year is defined as one-year value - baseline value. Positive change at one year indicates improved quality of life.
| score on a scale | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Bowel domain | -5.45 ± 9.10 | -7.04 ± 15.50 |
| Urinary domain | -1.67 ± 13.90 | -5.31 ± 15.46 |
| Sexual domain | -24.18 ± 27.64 | -27.26 ± 25.98 |
| Hormonal domain | -17.31 ± 15.36 | -17.45 ± 16.59 |
| ng/dL | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Baseline | 355.75 ± 225.65 | 357.73 ± 217.26 |
| 12 months | 35.68 ± 68.39 | 25.22 ± 67.49 |
| 24 months | 86.47 ± 182.40 | 17.36 ± 32.71 |
| mg/dL | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Baseline | 149.71 ± 68.20 | 154.20 ± 71.05 |
| 12 months | 160.27 ± 73.22 | 154.74 ± 70.85 |
| 24 months | 163.20 ± 168.63 | 160.61 ± 77.55 |
| mg/dL | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Baseline | 40.91 ± 20.96 | 41.32 ± 20.93 |
| 12 months | 44.94 ± 24.21 | 44.50 ± 24.21 |
| 24 months | 42.16 ± 23.77 | 44.85 ± 23.36 |
| mg/dL | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Baseline | 88.78 ± 45.64 | 87.85 ± 47.33 |
| 12 months | 86.18 ± 47.11 | 83.73 ± 46.86 |
| 24 months | 81.35 ± 47.73 | 95.34 ± 59.22 |
| g/dL | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Baseline | 6.12 ± 1.05 | 6.01 ± 1.05 |
| 12 months | 6.33 ± 1.18 | 5.95 ± 0.73 |
| 24 months | 6.30 ± 1.59 | 6.04 ± 0.76 |
| mg/dL | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Baseline | 98.99 ± 51.87 | 100.52 ± 45.54 |
| 12 months | 102.27 ± 53.06 | 117.39 ± 118.40 |
| 24 months | 104.24 ± 67.43 | 105.51 ± 40.53 |
No measurements were reported for this outcome.
Body Mass Index (BMI) is a person's weight in kilograms (or pounds) divided by the square of height in meters (or feet). Change from baseline = time point value - baseline value.
| kg/m^2 | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| 1 year | 0.64 ± 2.19 | -0.84 ± 4.28 |
| 2 years | 0.67 ± 3.76 | -0.34 ± 2.55 |
| 3 years | 0.75 ± 3.90 | 0.25 ± 2.32 |
| 4 years | -0.02 ± 6.95 | 0.46 ± 2.70 |
| 5 years | -0.52 ± 3.01 | 0.15 ± 2.71 |
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data
| Participants | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Grade 1 | 17 | 2 |
| Grade 2 | 54 | 45 |
| Grade 3 | 31 | 55 |
| Garde 4 | 4 | 9 |
| Grade 5 | 3 | 1 |
Testosterone recovery is defined as testosterone level after treatment greater than 230 ng/dL. Time to testosterone recovery is defined as time from randomization to the date of testosterone recovery, biochemical, local, or distant failure (competing risk), salvage therapy (competing risk), death (competing risk), or last known follow-up (censored). Testosterone recovery rates are estimated using the cumulative incidence method.
| percentage of participants | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| 12 months | 19.4 (12.5 to 27.3) | 12.5 (7.0 to 19.6) |
| 24 months | 32.9 (24.1 to 41.9) | 17.4 (10.8 to 25.4) |
Testosterone recovery is defined as testosterone level after treatment greater than 230 ng/dL. Testosterone recovery rates are estimated using the Kaplan-Meier method, censoring for biochemical, local, or distant failure, salvage therapy, death, and otherwise alive without event. Testosterone recovery time is defined as time from randomization to testosterone recovery or censoring.
| years | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Median Testosterone Recovery Time | NA (4.2 to NA) | NA (NA to NA) |
Clinical survivorship events are defined as the following newly diagnosed non-fatal cardiovascular events or other clinical endpoints relevant to prostate cancer survivorship: type 2 diabetes, coronary artery disease, myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis, and osteoporotic fracture.
| Participants | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Type 2 diabetes | 30 | 18 |
| Coronary artery disease | 16 | 14 |
| Myocardial infarction | 6 | 8 |
| Stroke | 5 | 6 |
| Pulmonary embolism | 10 | 5 |
| Deep vein thrombosis | 8 | 7 |
| Osteoporotic fracture | 6 | 1 |
Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from secondary (original protocol) to primary. Biochemical failure will be defined by the Phoenix definition (PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or the initiation of salvage androgen deprivation therapy. Time to failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here.
| percentage of participants | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Hispanic or Latino | 0 (NA to NA) | 0 (NA to NA) |
| Not Hispanic or Latino | 17.6 (10.9 to 25.6) | 13.6 (7.6 to 21.3) |
| Unknown or Not Reported | 0 (NA to NA) | 0 (NA to NA) |
Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from secondary (original protocol) to primary. Biochemical failure will be defined by the Phoenix definition (PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or the initiation of salvage androgen deprivation therapy. Time to failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here.
| percentage of participants | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| American Indian or Alaska Native | 0 (NA to NA) | — |
| Asian | 0 (NA to NA) | 0 (NA to NA) |
| Black or African American | 15.4 (2.2 to 39.9) | 25.0 (2.9 to 58.3) |
| White | 17.9 (10.5 to 26.8) | 12.2 (6.5 to 20.0) |
| Unknown or Not Reported | 20.0 (0.4 to 62.1) | 0 (NA to NA) |
Collected over From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ADT + RT | 24/115 (20.9%) | 19/112 (17%) | 108/112 (96.4%) |
| TAK-700 + ADT + RT | 19/116 (16.4%) | 38/115 (33%) | 112/115 (97.4%) |
| Event | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| Myocardial infarctionCardiac disorders | 3/112 | 4/115 |
| Atrial fibrillationCardiac disorders | 0/112 | 3/115 |
| StrokeNervous system disorders | 1/112 | 3/115 |
| Renal calculiRenal and urinary disorders | 0/112 | 3/115 |
| Thromboembolic eventVascular disorders | 1/112 | 3/115 |
| Acute coronary syndromeCardiac disorders | 2/112 | 1/115 |
| SyncopeNervous system disorders | 2/112 | 0/115 |
| HematuriaRenal and urinary disorders | 2/112 | 1/115 |
| Aortic valve diseaseCardiac disorders | 0/112 | 2/115 |
| FatigueGeneral disorders and administration site conditions | 1/112 | 2/115 |
| Event | ADT + RT | TAK-700 + ADT + RT |
|---|---|---|
| FatigueGeneral disorders and administration site conditions | 72/112 | 91/115 |
| Hot flashesVascular disorders | 83/112 | 89/115 |
| Urinary frequencyRenal and urinary disorders | 74/112 | 83/115 |
| DiarrheaGastrointestinal disorders | 61/112 | 69/115 |
| Urinary urgencyRenal and urinary disorders | 49/112 | 37/115 |
| Erectile dysfunctionReproductive system and breast disorders | 49/112 | 47/115 |
| Renal and urinary disorders - OtherRenal and urinary disorders | 42/112 | 46/115 |
| HyperglycemiaMetabolism and nutrition disorders | 33/112 | 39/115 |
| NauseaGastrointestinal disorders | 9/112 | 38/115 |
| HypertensionVascular disorders | 18/112 | 37/115 |
Eligible participants
| Age, Customized(Participants) | ADT + RT | TAK-700 + ADT + RT | Total |
|---|---|---|---|
| ≤ 49 years | 2 | 1 | 3 |
| 50 - 59 years | 16 | 22 | 38 |
| 60 - 69 years | 44 | 41 | 85 |
| ≥ 70 years | 53 | 52 | 105 |
| Sex: Female, Male(Participants) | ADT + RT | TAK-700 + ADT + RT | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 115 | 116 | 231 |
| Ethnicity (NIH/OMB)(Participants) | ADT + RT | TAK-700 + ADT + RT | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 5 | 7 |
| Not Hispanic or Latino | 111 | 109 | 220 |
| Unknown or Not Reported | 2 | 2 | 4 |
| Race (NIH/OMB)(Participants) | ADT + RT | TAK-700 + ADT + RT | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 14 | 10 | 24 |
| White | 93 | 101 | 194 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 6 | 4 | 10 |
| Zubrod Performance Status(Participants) | ADT + RT | TAK-700 + ADT + RT | Total |
|---|---|---|---|
| 0 | 99 | 104 | 203 |
| 1 | 16 | 12 | 28 |
| Gleason Score(Participants) | ADT + RT | TAK-700 + ADT + RT | Total |
|---|---|---|---|
| 7 | 16 | 18 | 34 |
| 8 | 37 | 30 | 67 |
| ≥9 | 62 | 68 | 130 |
| Study Entry PSA(Participants) | ADT + RT | TAK-700 + ADT + RT | Total |
|---|---|---|---|
| < 20.0 ng/ml | 75 | 75 | 150 |
| 20.0-150.0 ng/ml | 40 | 41 | 81 |
| T-Stage(Participants) | ADT + RT | TAK-700 + ADT + RT | Total |
|---|---|---|---|
| T1a-T1c | 22 | 23 | 45 |
| T2-T2c | 66 | 58 | 124 |
| T3-T3b | 24 | 33 | 57 |
| T4 | 3 | 2 | 5 |
5 further baseline measures are reported on the registry.
Showing the first 100 of 172 sites across 2 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2012 to primary completion in Nov 2021, 114 months.
Results were first posted in Apr 2023, 1 year 5 months after primary completion.
Of 139 non-industry phase 3 interventional studies under Prostatic Neoplasms, half reached primary completion within 99 months of starting (the median), counting those still running; a quarter within 57 and three quarters within 144. This study's 114 months is above that.
Counting every sponsor, half of 265 studies reached it within 57 months; a quarter within 31 and three quarters within 100.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Orteronel
Radiation Therapy Oncology Group →