A Phase 2, Open-label, Single-arm Study of TAK-700 (orteronel) in Patients With Nonmetastatic Castration-resistant Prostate Cancer and Rising Prostate-specific Antigen

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221969

Enrollment

Registered

2012-11-27

Start date

2012-11-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonmetastatic castration-resistant prostate cancer (CRPC) with rising prostate-specific antigen (PSA)

Interventions

investigational material(s) Generic name etc : TAK-700 (Orteronel) INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigation

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma - No radiographic evidence of metastasis confirmed - PSA rising defined as the following: increase in PSA - Prior surgical castration or concurrent use of an agent for medical castration - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria

Exclusion criteria: - Received prior chemotherapy for prostate cancer - Current spinal cord compression, bilateral hydronephrosis or current bladder neck outlet obstruction - Uncontrolled cardiovascular condition as specified in study protocol - Uncontrolled nausea, vomiting or diarrhea

Design outcomes

Primary

Measure	Time frame
PSA 50% response rate	—

Secondary

Measure	Time frame
PSA 90% and 30% response rate	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026