Clinical trial · Interventional
Cabazitaxel and Prednisone in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
A Selective Frontline Cabazitaxel Therapeutic Pathway for Castration-Resistant Prostate Cancer With Integrated Biomarkers
NCT02844582CI-TRIAL-00049603terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual of subjects onto study
Summary
Brief summary (as posted)
This phase II trial studies how well cabazitaxel and prednisone work in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as cabazitaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone-Resistant Prostate Cancer | — | UNRESOLVED | — |
| Stage IV Prostate Adenocarcinoma | Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabazitaxel | Drug | Cabazitaxel | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (cabazitaxel, prednisone)
- description
- Patients receive cabazitaxel IV over 1 hour on day 1 and prednisone PO BID on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Cabazitaxel
- Drug: Prednisone
Primary outcomes (1)
- measure
- PSA Response Rate, Defined as >= 50% Decline in PSA From Baseline Maintained for at Least 3 Weeks and Measured by the Same Laboratory, and Without Evidence of Other Disease Progression Documented at Time of Confirmatory Values
- timeFrame
- Up to 18 months.
- description
- The response rate will be compared to a historical response rate of 20% using the exact binomial test for a single proportion. Confidence intervals for the response rate will be calculated using Wilson's method.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed prostate adenocarcinoma * Metastatic disease * Able and willing to provide informed consent and to comply with the study procedures * Castration resistant disease defined as evidence of radiological and/or prostate specific antigen (PSA) progression despite castrate levels of testosterone (serum testosterone \< 50 ng/dL \[1.7 nmol/L\]); for PSA progression, there must be at least 2 sequential rises at a minimum of 1-week intervals; the first PSA value must be \>= 4 (Prostate Cancer Working Group 2 \[PCWG2\] criteria) * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * At least 21 days have passed since completing radiotherapy (exception for radiotherapy: at least 7 days since completing a single fraction of =\< 800 cGy to a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit) at the time of registration * At least 21 days have passed since receiving any investigational agent at the time of registration * At least 21 days have passed since major surgery * Neuropathy =\< grade 1 at the time of registration * Has recovered from all therapy-related toxicity to =\< grade 2 (except alopecia, anemia and any signs or symptoms of androgen deprivation therapy) at the time of registration * Poor prognosis disease as defined by any of the following: * PSA nadir \>=4.0, or * Gleason score 8-10, or * Time from ADT initiation to CRPC of =\< 16 months * Hemoglobin \>= 90 g/L * Neutrophils \>= 1.5 x 10\^9 /L * Platelets \>= 100 x 10\^9/L * Aspartate aminotransferase (AST) \< 1.5 x upper limit of normal (ULN) * Alanine aminotransferase (ALT) \< 1.5 x ULN * Bilirubin =\< 1.0 x ULN (exceptions for Gilbert's syndrome) * Creatinine =\< 1.5 x ULN Exclusion Criteria: * Prior therapy with cabazitaxel or to other drugs formulated with polysorbate 80 * Prior taxanes for CRPC * Prior enzalutamide, abiraterone or ketoconazole * Other condition, illness, psychiatric condition, or laboratory abnormality that may increase the risk associated with administration of cabazitaxel, study participation, or may interfere with the interpretation of study results and in the judgment of the investigator would make the patient inappropriate for entry into this study * Histologic evidence of small cell/neuroendocrine prostate cancer * Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period and up to 6 months after the last administered dose; the definition of "effective method of contraception" will be based on the investigator's judgment
References
Publications (0)
Data not yet available
No reference posted for this study.