A Phase 3 interventional study of TAK-700 and Bicalutamide in Prostate Cancer, sponsored by SWOG Cancer Research Network. Completed at 560 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by SWOG Cancer Research Network · Phase 3, Interventional, and Treatment
The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 1,313 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: TAK-700
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
Drug: Bicalutamide
300 mg, PO, twice daily
Also known as: Orteronel
50 mg, PO, q daily
Also known as: Casodex
Overall Survival
Overall survival is defined as the time from random assignment to the date of death from any cause
Time frame: Duration of treatment and follow-up until death or 9 years after study start
Progression Free Survival
Progression Free Survival (PFS) is defined as the time from random assignment to first documentation of PSA progression, radiologic progression, clinical progression, or death, whichever occurred first. PSA progression is defined as a ≥25% increase AND and absolute increase of at last 2 ng/mL from the nadir PSA (or from baseline PSA if there was no drop in PSA after starting treatment). Radiologic progression is defined as two or more new lesions on radionuclide bone scans. Clinical progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Duration of treatment and follow-up until death or 9 years after study start
PSA Response Rates
Prostate-specific antigen (PSA) response rates were 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 landmark after random assignment.
Time frame: 7 months after randomization
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Only adverse events that are possibly, probably or definitely related to study drug are reported. Adverse events are graded using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) where grade refers to the severity of the AE. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Time frame: Duration of treatment and follow-up until death or 9 years after study start
Long-term Survival
Long-term survival is defined as the time from random assignment to the date of death from any cause
Time frame: After 10 years of follow-up
| Milestone | LHRHa + TAK-700 | LHRHa + Bicalutamide |
|---|---|---|
| Started | 638 | 641 |
| Completed | 0 | 0 |
| Not completed | 638 | 641 |
| Withdrew: Currently on treatment | 192 | 100 |
| Withdrew: No protocol treatment | 10 | 11 |
| Withdrew: Adverse event | 80 | 21 |
| Withdrew: Disease progression | 226 | 372 |
| Withdrew: Death | 26 | 13 |
| Withdrew: Participant refusal | 70 | 72 |
| Withdrew: Other, not specified | 34 | 52 |
Overall survival is defined as the time from random assignment to the date of death from any cause
| months | LHRHa + TAK-700 | LHRHa + Bicalutamide |
|---|---|---|
| Overall Survival | 81.1 (68.0 to NA) | 70.2 (64.6 to 79.5) |
Progression Free Survival (PFS) is defined as the time from random assignment to first documentation of PSA progression, radiologic progression, clinical progression, or death, whichever occurred first. PSA progression is defined as a ≥25% increase AND and absolute increase of at last 2 ng/mL from the nadir PSA (or from baseline PSA if there was no drop in PSA after starting treatment). Radiologic progression is defined as two or more new lesions on radionuclide bone scans. Clinical progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
| months | LHRHa + TAK-700 | LHRHa + Bicalutamide |
|---|---|---|
| Progression Free Survival | 47.6 (42.2 to 54.2) | 23.0 (19.3 to 26.3) |
Prostate-specific antigen (PSA) response rates were 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 landmark after random assignment.
| percentage of participants | LHRHa + TAK-700 | LHRHa + Bicalutamide |
|---|---|---|
| Complete Response | 58 | 44 |
| Partial Response | 22 | 31 |
| No Response | 19 | 25 |
Only adverse events that are possibly, probably or definitely related to study drug are reported. Adverse events are graded using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) where grade refers to the severity of the AE. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
| Participants | LHRHa + TAK-700 | LHRHa + Bicalutamide |
|---|---|---|
| Abdominal pain | 4 | 0 |
| Acute coronary syndrome | 1 | 1 |
| Acute kidney injury | 0 | 2 |
| Adrenal insufficiency | 2 | 0 |
| Adult respiratory distress syndrome | 1 | 0 |
| Agitation | 0 | 1 |
| Alanine aminotransferase increased | 10 | 2 |
| Alkaline phosphatase increased | 9 | 3 |
| Allergic reaction | 2 | 0 |
| Anaphylaxis | 1 | 0 |
| Anemia | 1 | 2 |
| Anorexia | 4 | 1 |
| Anxiety | 1 | 2 |
| Arthralgia | 5 | 2 |
| Arthritis | 1 | 0 |
| Aspartate aminotransferase increased | 7 | 3 |
| Atrial fibrillation | 8 | 0 |
| Back pain | 1 | 0 |
| Blood bilirubin increased | 4 | 1 |
| Bone pain | 0 | 3 |
| Cardiac arrest | 0 | 1 |
| Cardiac disorders - Other, specify | 1 | 0 |
| Cardiac troponin I increased | 1 | 0 |
| Chest pain - cardiac | 4 | 0 |
| Colitis | 2 | 0 |
| Concentration impairment | 1 | 0 |
| Confusion | 1 | 1 |
| Constipation | 2 | 0 |
| Creatinine increased | 1 | 1 |
| Death NOS | 1 | 0 |
| Dehydration | 2 | 1 |
| Depression | 7 | 2 |
| Diarrhea | 10 | 2 |
| Dizziness | 3 | 1 |
| Dysphagia | 1 | 0 |
| Dyspnea | 9 | 1 |
| Edema limbs | 4 | 0 |
| Ejection fraction decreased | 1 | 0 |
| Encephalopathy | 1 | 1 |
| Erectile dysfunction | 4 | 4 |
| Esophagitis | 1 | 0 |
| Fall | 2 | 0 |
| Fatigue | 34 | 11 |
| Fever | 1 | 0 |
| Flank pain | 1 | 0 |
| Flu like symptoms | 1 | 0 |
| GGT increased | 1 | 0 |
| Gastric hemorrhage | 1 | 0 |
| Gastric ulcer | 1 | 0 |
| General disorders and admin site conditions - Other | 0 | 1 |
| Generalized muscle weakness | 4 | 1 |
| Gynecomastia | 1 | 0 |
| Headache | 3 | 1 |
| Heart failure | 6 | 2 |
| Hematuria | 1 | 2 |
| Hepatobiliary disorders - Other, specify | 1 | 0 |
| Hip fracture | 3 | 0 |
| Hoarseness | 0 | 1 |
| Hot flashes | 5 | 5 |
| Hyperglycemia | 11 | 6 |
| Hyperkalemia | 2 | 0 |
| Hypertension | 127 | 28 |
| Hypertriglyceridemia | 1 | 3 |
| Hyperuricemia | 1 | 0 |
| Hypokalemia | 20 | 1 |
| Hyponatremia | 5 | 1 |
| Hypophosphatemia | 0 | 1 |
| Hypotension | 2 | 1 |
| Hypoxia | 2 | 0 |
| Infections and infestations - Other, specify | 2 | 0 |
| Insomnia | 2 | 1 |
| Investigations - Other, specify | 1 | 0 |
| Joint infection | 1 | 0 |
| Laryngeal edema | 1 | 0 |
| Left ventricular systolic dysfunction | 2 | 0 |
| Leukocytosis | 1 | 0 |
| Lipase increased | 9 | 0 |
| Lung infection | 5 | 0 |
| Lymphocyte count decreased | 3 | 0 |
| Mucositis oral | 1 | 0 |
| Multi-organ failure | 0 | 1 |
| Muscle weakness lower limb | 0 | 2 |
| Musculoskeletal and connective tiss disorder - Other | 3 | 0 |
| Myalgia | 1 | 0 |
| Myocardial infarction | 5 | 0 |
| Nausea | 5 | 0 |
| Neutrophil count decreased | 1 | 1 |
| Obesity | 0 | 2 |
| Osteoporosis | 1 | 1 |
| Otitis media | 1 | 0 |
| Pain | 3 | 1 |
| Pancreatitis | 7 | 0 |
| Peripheral sensory neuropathy | 1 | 0 |
| Platelet count decreased | 0 | 1 |
| Pneumonitis | 1 | 0 |
| Pruritus | 1 | 0 |
| Pulmonary edema | 1 | 0 |
| Pulmonary hypertension | 1 | 0 |
| Renal calculi | 0 | 2 |
| Resp, thoracic and mediastinal disorders - Other | 2 | 0 |
| Serum amylase increased | 2 | 0 |
| Skin and subcutaneous tissue disorders - Other | 1 | 0 |
| Spinal fracture | 0 | 1 |
| Stroke | 2 | 1 |
| Supraventricular tachycardia | 1 | 0 |
| Syncope | 4 | 3 |
| Thromboembolic event | 6 | 0 |
| Thrombotic thrombocytopenic purpura | 1 | 0 |
| Urinary tract infection | 4 | 1 |
| Urostomy stenosis | 0 | 1 |
| Ventricular fibrillation | 1 | 0 |
| Ventricular tachycardia | 1 | 0 |
| Vomiting | 4 | 0 |
| Weight gain | 3 | 2 |
| Weight loss | 4 | 1 |
Long-term survival is defined as the time from random assignment to the date of death from any cause
Results for this outcome have not been posted.
Collected over Duration of treatment and follow-up until death or 9 years after study start. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LHRHa + TAK-700 | 251/638 (39.3%) | 235/627 (37.5%) | 615/627 (98.1%) |
| LHRHa + Bicalutamide | 274/641 (42.7%) | 15/629 (2.4%) | 609/629 (96.8%) |
| Event | LHRHa + TAK-700 | LHRHa + Bicalutamide |
|---|---|---|
| HypertensionVascular disorders | 44/627 | 0/629 |
| Lung infectionInfections and infestations | 24/627 | 0/629 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 23/627 | 0/629 |
| Thromboembolic eventVascular disorders | 20/627 | 0/629 |
| Atrial fibrillationCardiac disorders | 18/627 | 0/629 |
| Chest pain - cardiacCardiac disorders | 16/627 | 0/629 |
| Abdominal painGastrointestinal disorders | 16/627 | 0/629 |
| Urinary tract infectionInfections and infestations | 14/627 | 0/629 |
| SyncopeNervous system disorders | 13/627 | 0/629 |
| Heart failureCardiac disorders | 12/627 | 0/629 |
| Event | LHRHa + TAK-700 | LHRHa + Bicalutamide |
|---|---|---|
| Hot flashesVascular disorders | 448/627 | 453/629 |
| FatigueGeneral disorders | 445/627 | 346/629 |
| HypertensionVascular disorders | 364/627 | 222/629 |
| AnemiaBlood and lymphatic system disorders | 340/627 | 271/629 |
| HyperglycemiaMetabolism and nutrition disorders | 244/627 | 172/629 |
| ConstipationGastrointestinal disorders | 228/627 | 133/629 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 220/627 | 147/629 |
| NauseaGastrointestinal disorders | 214/627 | 86/629 |
| Back painMusculoskeletal and connective tissue disorders | 213/627 | 194/629 |
| PainGeneral disorders | 208/627 | 156/629 |
| Age, Continuous(years) | LHRHa + TAK-700 | LHRHa + Bicalutamide | Total |
|---|---|---|---|
| Median | 67.6 (46.1 to 90.0) | 68.1 (19.4 to 92.3) | 67.8 (19.4 to 92.3) |
| Sex: Female, Male(Participants) | LHRHa + TAK-700 | LHRHa + Bicalutamide | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 638 | 641 | 1279 |
| Race/Ethnicity, Customized(Participants) | LHRHa + TAK-700 | LHRHa + Bicalutamide | Total |
|---|---|---|---|
| White | 539 | 538 | 1077 |
| Black | 64 | 71 | 135 |
| Others | 35 | 32 | 67 |
| Zubrod Performance Status Score(Participants) | LHRHa + TAK-700 | LHRHa + Bicalutamide | Total |
|---|---|---|---|
| 0 | 416 | 442 | 858 |
| 1 | 197 | 175 | 372 |
| 2 | 21 | 21 | 42 |
| 3 | 3 | 2 | 5 |
| Missing | 1 | 1 | 2 |
| Gleason Score at Initial Diagnosis(Participants) | LHRHa + TAK-700 | LHRHa + Bicalutamide | Total |
|---|---|---|---|
| < 7 | 46 | 39 | 85 |
| 7 | 165 | 168 | 333 |
| 8 | 123 | 118 | 241 |
| 9-10 | 249 | 264 | 513 |
| Missing | 55 | 52 | 107 |
| Median PSA Level(ng/mL) | LHRHa + TAK-700 | LHRHa + Bicalutamide | Total |
|---|---|---|---|
| Median | 27.2 (2.0 to 6710.0) | 31.8 (2.0 to 6651.2) | 29.7 (2.0 to 6710.0) |
| Bone Pain(Participants) | LHRHa + TAK-700 | LHRHa + Bicalutamide | Total |
|---|---|---|---|
| Yes | 158 | 143 | 301 |
| No | 480 | 498 | 978 |
| Bone Metastases(Participants) | LHRHa + TAK-700 | LHRHa + Bicalutamide | Total |
|---|---|---|---|
| Yes | 470 | 482 | 952 |
| No | 168 | 159 | 327 |
7 further baseline measures are reported on the registry.
Showing the first 100 of 560 sites.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — https://swog.org/Visitors/Download/Policies/Policy43.pdf
This study is completed, as verified in Dec 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.
SWOG Cancer Research Network