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NCT Number: NCT02217566

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Porto Alegre, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: ZYTIGA®, JNJ-212082

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.

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.

Primary outcomes

  1. Time to Prostate-specific Antigen (PSA) Progression

    Time frame: Up to 2 years

    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).

Secondary outcomes

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

    Time frame: Week 12 to any time up to 2 years

    The PSA response according to Prostate Specific Antigen Working Group 3 criteria was defined as at least 50% decrease in PSA level from Baseline.

  2. Overall Survival

    Time frame: Up to 4 years

    Overall survival was defined as the time from date of the first dose of abiraterone acetate to the date of death due to any cause. For participants who did not die until the time of analysis, survival time was censored at the time of last contact alive.

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

    Time frame: Up to 2 years

    The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 [no pain] to 10 [pain as bad as you can imagine]). Pain severity progression was defined as an increase in score of 30% or greater from baseline without decrease in analgesic use.

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

    Time frame: Up to 2 years

    The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain interference score is mean value for the 7 BPI-SF questions (questions inquiring about the extent of interference with activities by pain) where the extent is ranked from 0 (does not interfere) to 10 (completely interferes). Pain interference progression was defined as an increase in score of 50% or greater from baseline without decrease in analgesic use.

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

    Time frame: Up to 4 years

    An AE is any untoward medical occurrence in a participant who will receive study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

Abiraterone Acetate in Patients With Metastatic Castration-Resistant Prostate Cancer, Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Aug 15, 2014
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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