Clinical trial NCT02217566: Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy
Official title: Abiraterone Acetate in Patients With Metastatic Castration-Resistant Prostate Cancer, Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Keywords: Prostatic neoplasms
Diethylstilbestrol therapy
Abiraterone acetate
Prednisone
Androgen deprivation therapy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2014-08-15
Enrollment: 46
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, based on prostate-specific antigen (PSA) progression, of abiraterone acetate in participants with metastatic (spread of cancer cells from one part of the body to another) castration (any action, surgical, chemical, or otherwise, by which a male loses the functions of the testes) resistant prostate cancer (cancer in prostrate; a gland that makes fluid that aids movement of sperm) (mCRPC), chemo-naive (treatment of cancer is not done using drugs), who received a prior diethylstilbestrol therapy (DES).

Detailed description: This is a Phase 2, multinational (when medical research study takes place in more than one country), multicenter (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), and single arm study to determine benefits of abiraterone acetate and low-dose prednisone to androgen deprivation therapy (ADT) in mCRPC participants who failed to prior DES therapy. The study will consist of a Screening Phase of up to 28 days before enrollment; a PSA Evaluation Phase; and a Follow-up Phase of up to 24 months. Each cycle of abiraterone therapy will be of 28 days. Participants will receive 1000 milligram (mg) abiraterone acetate orally once daily plus prednisone 5 mg orally once daily plus stable regimen of ADT (luteinizing hormone-releasing hormone \[LHRH\] agonists) as per Investigator's discretion. Treatment will continue until PSA progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity. Efficacy will primarily be assessed by time to PSA progression. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
* Prior therapy with diethylstilbestrol (DES) for castration resistant prostate cancer. Participants should demonstrate evidence of progression on DES or evidence of grades 3/4 toxicities on DES
* Metastatic disease documented by positive bone scan or metastatic lesions on computerized tomography (CT) or magnetic resonance imaging (MRI)
* May have received prior androgen blockage (bicalutamide or flutamide) but must have been discontinued for least 28 days
* Ongoing androgen deprivation therapy (ADT) (luteinizing hormone-releasing hormone \[LHRH\] agonist or orchiectomy), with serum testosterone level of less than 50 nanogram per deciliter (1.7 nanomole per liter) and eligible participants must maintain ADT

Exclusion Criteria:

* Active infection or other medical condition that would make prednisone use contraindicated
* Any chronic medical condition requiring a higher systemic dose of corticosteroid than 5 milligram (mg) prednisone per day
* Pathological finding consistent with small cell carcinoma of the prostate
* Known brain metastasis
* Has had prior cytotoxic chemotherapy or biologic therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC)

Primary outcomes:
measure: Time to Prostate-specific Antigen (PSA) Progression
timeFrame: Up to 2 years
Secondary outcomes:
measure: Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response
timeFrame: Week 12 to any time up to 2 years
measure: Overall Survival
timeFrame: Up to 4 years
measure: Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Severity Score
timeFrame: Up to 2 years
measure: Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Interference Score
timeFrame: Up to 2 years
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
city: Rio De Janeiro
country: Brazil
city: Santo Andre
country: Brazil
city: Sao Paulo
country: Brazil
city: São Paulo
country: Brazil
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: