High or Intermediate Risk, Untreated, Clinically Localised Prostate Cancer
Conditions
Interventions
Product Name: Orteronel
Product Code: TAK700
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Proposed INN - Orteronel
CAS Number: 566939853
Current Sponsor code: TAK-700
Other descriptive
Sponsors
Queen Mary, University of London
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent 2. No previous treatment for prostate cancer (including surgery, any hormone therapy, radiotherapy, cryotherapy). 3. Age = 18 years and male 4. Histologically or cytologically confirmed adenocarcinoma of the prostate with Gleason score. 5. A prostate biopsy within 8 weeks from screening is allowed for entry requirements. 6. Intermediate or high risk prostate cancer according to National Comprehensive Cancer Network (NCCN) risk stratification criteria: Intermediate: PSA >10 & 20 or Gleason 8-10 or clinical stage >T2c 7. Serum testosterone > 200 ng/dL 8. Prostatectomy is the planned treatment option. 9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 10. Adequate organ function, defined as follows: Haemoglobin >10.0g/dL Absolute neutrophil count > 1.5 x 109/L Platelet count >100 x 109/L AST and /or ALT =65 years) yes F.1.3.1 Number of subjects for this age range 91
Exclusion criteria
Exclusion criteria: 1. Serious co-existent medical conditions, such as chronic active autoimmune disease, (within the last 6 months) or infection (such as hepatitis). 2. Uncontrolled hypertension within the screening period (systolic BP = 160 mmHg or diastolic BP = 95 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy. 3. Patients taking regular oral steroids for any reason. 4. Previously treated prostate cancer (including radiotherapy, hormone therapy or surgery). 5. History of pituitary or adrenal dysfunction 6. Other active malignancy over the last 5 years that has required systemic therapy excluding: a. Adjuvant therapy in the curative setting b. Non-melanoma skin cancer c. Superficial transitional cell carcinoma (CIS-T1). 7. History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug 8. Current enrolment in an investigational drug or device study or participation in such a study within 30 days of Day 1 9. Not willing to comply with the procedural requirements of this protocol. 10. Patients who have partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 16 weeks after last study drug administration. 11. Uncontrolled diabetes mellitus, in the opinion of the treating physician. 12. Known hypersensitivity to compounds related to TAK-700 or to TAK-700 excipients. 13. Hypersensitivity to any of the ingredients or to synthetic Gn-RH or Gn-RH derivatives. 14. Screening calculated ejection fraction of = 50% by echocardiogram. 15. History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade > 2 (NCI CTCAE, version 4.02), thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g., pericardial effusion restrictive cardiomyopathy) within 6 months prior to first dose of study drug. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed. 16. New York Heart Association Class III or IV heart failure 17. ECG abnormalities of Q-wave infarction, unless identified 6 or more months prior to screening 18. QTc interval > 460 msec on ECG
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if neoadjuvant TAK-700 with LHRH agonists and prostatectomy is associated with a delay in progression- free survival compared to prostatectomy alone. The primary endpoint will assess the 3 year biochemical progression free survival (PSA);Secondary Objective: To evaluate response (Complete Response and Partial Response) after at least 12 and 24 weeks of treatment with the study drugs;Primary end point(s): Assess the 3 year biochemical progression free survival (PSA) defined as a post-operative serum PSA of greater or equal to 0.2 ng/dl on 2 separate occasions as defined by the AUA. ;Timepoint(s) of evaluation of this end point: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The proportion of men with an undetectable serum PSA following surgery • Response rate as determined by MRI (T2 sequence) after 12 and 24 weeks of therapy (study arm only) • Positive margin rate post surgery. • Proportion of patients receiving post operative radiotherapy. • Pathological complete response rate. ;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
United Kingdom
Contacts
Public ContactNeera Maroo
Queen Mary University of London
Outcome results
None listed