Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Kennedy Disease

All Drugs and Chemicals

Antineoplastic Agents

Anti-Inflammatory Agents

Androgens

Abiraterone Acetate

Prednisone

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Participants received Cabazitaxel 25 mg/m\^2, intravenously for 1 hour along with prednisone 10 mg orally on Day 1 of every treatment cycle (each cycle was of 3 weeks) until disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally, until disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Cabazitaxel XRP6258

Ezalutamide

Abiraterone acetate

Clinical Sciences & Operations

Primary Objective:

To demonstrate the superiority in term of radiographic Progression-Free Survival (rPFS) of cabazitaxel at at 25 milligram per meter square (mg/m\^2) plus prednisone (Arm A) versus either enzalutamide at 160 milligram (mg) once daily or abiraterone acetate at 1000 mg once daily plus prednisone (Arm B) in chemotherapy-naïve participants with metastatic Castration-Resistant Prostate Cancer (mCRPC) who have disease progression while receiving androgen receptor (AR) targeted therapy (abiraterone plus prednisone or enzalutamide) within 12 months of treatment initiation (≤12 months).

Secondary Objective:

* To compare efficacy for:
* Prostate-specific antigen (PSA) response rate and Time to PSA progression (TTPP).
* Progression Free Survival (PFS).
* Overall Survival (OS).
* Tumor response rate in participants with measurable disease (RECIST 1.1)
* Pain response and time to pain progression.
* Symptomatic skeletal events (SSE) rate and time to occurrence of any SSE.
* To analyze messenger ribonucleic acids (mRNAs) including androgen-receptor splice variant 7 messenger RNA (AR-V7) as a biomarker in Circulating Tumor Cells (CTCs).
* To evaluate safety in the 2 treatment arms.

The duration of the study per participant was approximately 2 years. Each participant was treated until radiographic disease progression, unacceptable toxicity, or participants refusal of further study treatment, and each participant was followed after completion of study treatment until death, study cutoff date, or withdrawal of participant consent.

Cabazitaxel Versus the Switch to Alternative AR Targeted Therapy Enzalutamide or Abiraterone in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Primary Resistant Patients to Abiraterone or Enzalutamide

Phase II, Randomized, Open-label, Multicenter Study in Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Who Have PRIMary Resistance to Abiraterone Acetate or Enzalutamide Treatment Comparing the Anti-tumor Effect of CABazitaxel to Alternative Androgen Receptors (AR) Targeted Therapy

rPFS was defined as the time from randomization to the first occurrence of radiological tumor progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or progression of bone lesions using prostate cancer working group 2 (PCWG2) criteria or death due to any cause.

PSA response was defined as decline of serum PSA from baseline by \>= 50 percent (%).

PFS: time interval between date of randomization to first documentation of tumor progression as per RECIST 1.1.

Overall Survival was defined as the time interval from the date of randomization to the date of death due to any cause.

Time to PSA progression was defined as the time interval between the date of randomization and the date of first documented PSA progression as per PCWG2 criteria.

Tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1.

Duration of tumor response was defined as the time between the first evaluation at which the tumor response criteria were met and the first documentation of tumor progression.

Pain response was analyzed using the brief pain inventory-short form (BPI-SF).

Time to pain progression was defined as the time interval between the date of randomization and the date of the first documented pain progression.

SSE was the occurrence of a new symptomatic pathological fracture, or the use of external beam radiation to relieve bone pain, or the occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention.

Time to SSE was defined as the time interval between the date of randomization and the date of the occurrence of the first event defining a SSE, whichever is earlier.

Sanofi

Participants received Cabazitaxel 25 mg/m\^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Cabazitaxel

Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Enzalutamide or Abiraterone

Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Abiraterone

Participants received enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Enzalutamide

Abiraterone Acetate or Enzalutamide

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

All randomized participants who were exposed to at least one dose of study treatment.

Trial Transparency Team

Planned analysis could not be performed due to early study termination.

Radiographic Progression-Free Survival (rPFS)

Number of Participants With Prostate Specific Antigen (PSA) Response

Progression-free Survival (PFS)

Overall Survival

Time to PSA Progression

Number of Participants Achieving Tumor Response

Duration of Tumor Response

Pain Response Using Brief Pain Inventory-Short Form (BPI-SF) for Pain Intensity Score

Time to Pain Progression

Percentage of Participants With Symptomatic Skeletal Event (SSE)

Time to Occurrence of Any Symptomatic Skeletal Events (SSE)

Participants received Cabazitaxel 25 milligrams per meter square (mg/m\^2), intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 milligrams (mg) orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Spots Global Cancer Trial Database for ezalutamide

Every month we try and update this database with for ezalutamide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ezalutamide

Every month we try and update this database with for ezalutamide cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ezalutamide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.