Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy

NCT02217566 | Completed Phase 2 Results

• 2 other identifiers: CR103352212082PCR2036
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

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).

Conditions

Prostatic Neoplasms

Keywords

Prostatic neoplasms; Diethylstilbestrol therapy; Abiraterone acetate; Prednisone; Androgen deprivation therapy

Outcome Measures

Primary Outcomes (1)

• Time to Prostate-specific Antigen (PSA) Progression

  Time to PSA progression was calculated from date of enrollment to the date of first documentation of PSA progression. As per Prostate Cancer Clinical Trials Working Group (PCWG2) criteria, PSA progression was defined as greater than or equal to (\>=) 25 percent (%) and \>=2 nanogram/milliliter (ng/mL) after 12 weeks (in case of no decline in PSA from Baseline), or first PSA increase that is \>=25% and \>=2 ng/mL above the nadir, and which was confirmed by a second value 3 or more weeks later (in case of decline of PSA from Baseline).

  Up to 2 years

Secondary Outcomes (5)

• Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response

  Week 12 to any time up to 2 years

• Overall Survival

  Up to 4 years

• Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Severity Score

  Up to 2 years

• Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Interference Score

  Up to 2 years

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to 4 years

Study Arms (1)

Abiraterone Acetate

EXPERIMENTAL

Participants will receive abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.

Drug: Abiraterone acetate; Drug: Prednisone; Drug: Androgen deprivation therapy (ADT)

Interventions

Abiraterone acetate DRUG

Participants will receive abiraterone acetate 1000 mg (4\*250 mg tablets) orally once daily until PSA progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.

Also known as: ZYTIGA®, JNJ-212082

Abiraterone Acetate

Prednisone DRUG

Participants will prednisone 5 mg orally once daily from Day 1 of Cycle 1 and continues until PSA progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.

Abiraterone Acetate

Androgen deprivation therapy (ADT) DRUG

Participants will remain on a stable regimen of ADT, that is, luteinizing hormone-releasing hormone (LHRH) agonists including leuprolide acetate and goserelin acetate as per Investigator's discretion.

Abiraterone Acetate

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (4)

Unknown Facility

Porto Alegre, Brazil

Location

Unknown Facility

Rio de Janeiro, Brazil

Location

Unknown Facility

Santo André, Brazil

Location

Unknown Facility

São Paulo, Brazil

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; Prednisone; Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Regional Medical Affairs Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: August 15, 2014
• Study Start: September 23, 2014
• Primary Completion: October 26, 2018
• Study Completion: October 26, 2018
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2020-01

Locations

BR (4)