Clinical trial · Interventional
Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.
A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Orteronel | Drug | — | UNRESOLVED |
| Orteronel Placebo | Drug | — | UNRESOLVED |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Orteronel + prednisone
- interventionNames
- Drug: Orteronel
- Drug: Prednisone
- type
- PLACEBO_COMPARATOR
- label
- Placebo + prednisone
- interventionNames
- Drug: Prednisone
- Drug: Orteronel Placebo
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Baseline until death (approximately up to 4.5 years)
- description
- Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Each participant must meet all of the following inclusion criteria: * Voluntary written consent * Male 18 years or older * Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma * Radiograph-documented metastatic disease * Progressive disease * Prior surgical castration or concurrent use of an agent for medical castration * Progressive disease during or following 1 or 2 regimens of cytotoxic chemotherapy, 1 of which must have included docetaxel. Must have received greater than or equal to (\>=) 360 milligram per square meter (mg/m\^2) of docetaxel within a 6-month period. Participants who were clearly intolerant to docetaxel or develop progressive disease before receiving \>= 360 mg/m\^2 are also eligible if they have received at least 225 mg/m\^2 of docetaxel within a 6-month period and meet the other study entry criteria. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Even if surgically sterilized, participants must practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, OR Abstain from heterosexual intercourse * Screening laboratory values as specified in protocol * Stable medical condition * Life expectancy of 6 months or more * Participants who have had up to 2 prior chemotherapy treatments are eligible to participate Exclusion Criteria: Participants meeting any of the following exclusion criteria are not to be enrolled in the study: * Known hypersensitivity to orteronel, prednisone or gonadotropin-releasing hormone (GnRH) analogue * Received prior therapy with orteronel, aminoglutethimide, ketoconazole or abiraterone * Any other therapies for prostate cancer, except for GnRH analogue therapy, must be discontinued 2 weeks before the first dose of study drug * Radioisotope therapy or external beam radiation therapy within 4 weeks of first dose of study drug * Documented central nervous system metastases * Treatment with any investigational compound within 30 days prior to first dose of study drug (Participants who are in long-term follow-up following active treatment in other trials are eligible) * Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected * Uncontrolled cardiovascular condition as specified in study protocol * Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C * Unwilling or unable to comply with protocol * Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of orteronel * Uncontrolled nausea, vomiting, or diarrhea despite appropriate medical therapy * Prostate cancer confined to just the prostrate bed or immediate adjacent tissue
References
Publications (3)
- DERIVEDHeller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22. PMID 29272162
- DERIVEDSuri A, Chapel S, Lu C, Venkatakrishnan K. Physiologically based and population PK modeling in optimizing drug development: A predict-learn-confirm analysis. Clin Pharmacol Ther. 2015 Sep;98(3):336-44. doi: 10.1002/cpt.155. Epub 2015 Jul 14. PMID 26031410
- DERIVEDFizazi K, Jones R, Oudard S, Efstathiou E, Saad F, de Wit R, De Bono J, Cruz FM, Fountzilas G, Ulys A, Carcano F, Agarwal N, Agus D, Bellmunt J, Petrylak DP, Lee SY, Webb IJ, Tejura B, Borgstein N, Dreicer R. Phase III, randomized, double-blind, multicenter trial comparing orteronel (TAK-700) plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer that has progressed during or after docetaxel-based therapy: ELM-PC 5. J Clin Oncol. 2015 Mar 1;33(7):723-31. doi: 10.1200/JCO.2014.56.5119. Epub 2015 Jan 26. PMID 25624429