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A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01715285
First received: October 24, 2012
Last updated: May 30, 2017
Last verified: May 2017
  Purpose
The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate and low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).

Condition Intervention Phase
Prostate Neoplasms Drug: Abiraterone acetate Drug: Prednisone Other: Androgen deprivation therapy (ADT) Drug: Abiraterone acetate Placebo Drug: Prednisone Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Up to Month 60 ]
    The OS is defined as the time from randomization to date of death from any cause.

  • Radiographic progression-free survival (PFS) [ Time Frame: Until End of Treatment (30 days after the final dose of study drug) ]
    Radiographic PFS is defined as the time from randomization to the occurrence of radiographic progression or death from any cause. Radiographic progression will be assessed for soft tissue lesion using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and bone lesion using modified Prostate Cancer Working Group 2 (PCWG2 ) criteria.


Secondary Outcome Measures:
  • Time to next skeletal-related event [ Time Frame: Up to Month 60 ]
    Time to next skeletal related event will be reported.

  • Time to prostate specific antigen (PSA) progression [ Time Frame: Cycles 1-13 Day 1, Day 1 every other cycle starting Cycle 14 to end-of-treatment up to disease progression ]
    Time to PSA progression will be calculated by PCWG2 criteria.

  • Time to subsequent therapy for prostate cancer [ Time Frame: Up to Month 60 ]
    Time to subsequent therapy for prostate cancer will be reported.

  • Time to initiation of chemotherapy [ Time Frame: Up to Month 60 ]
    Time to initiation of chemotherapy will be reported.

  • Time to Pain Progression [ Time Frame: Until End of Treatment (30 days after the final dose of study drug) ]
    Time to Pain Progression will be reported.


Enrollment: 1215
Actual Study Start Date: February 12, 2013
Estimated Study Completion Date: July 5, 2021
Estimated Primary Completion Date: July 10, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abiraterone acetate + Prednisone + ADT
Participants will receive abiraterone acetate tablet at a total dose of 1000 milligram (mg) along with 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) will be administered.
Drug: Abiraterone acetate
Abiraterone acetate tablets will be administered orally at a total dose of 1000 mg per day until disease progression, withdrawal of consent or unacceptable toxicity.
Other Name: Zytiga
Drug: Prednisone
Prednisone 5 mg capsule will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
Other: Androgen deprivation therapy (ADT)
All participants will receive stable regimen of ADT, that is, lutenizing hormone releasing hormone (LHRH) agonists or surgical castration according to local guidelines until disease progression, withdrawal of consent or unacceptable toxicity.
Drug: Abiraterone acetate Placebo
Placebo matched to abiraterone acetate will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
Placebo Comparator: Placebo + Androgen Deprivation Therapy (ADT)
Participants will receive placebo matched to abiraterone acetate and prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT will be administered.
Other: Androgen deprivation therapy (ADT)
All participants will receive stable regimen of ADT, that is, lutenizing hormone releasing hormone (LHRH) agonists or surgical castration according to local guidelines until disease progression, withdrawal of consent or unacceptable toxicity.
Drug: Abiraterone acetate Placebo
Placebo matched to abiraterone acetate will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
Drug: Prednisone Placebo
Placebo matched to prednisone will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.

Detailed Description:
This is a randomized (the treatment group is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study designed to determine the efficacy of abiraterone acetate and low-dose prednisone in participants with mHNPC. The study consists of 4 parts: Screening Phase (that is, 28 days before study commences on Day 1); Double-blind treatment Phase (consists of 4-week dosing cycles wherein abiraterone acetate will be administered as 1,000 milligram [mg] along with 5 mg prednisone or only placebo orally); Follow-up Phase (every 4 months up to 60 months or until death, lost to follow up, withdrawal of consent or study termination) Open-label Extension (OLE) Phase. Participants in the Double-blind Treatment Phase will have the opportunity to enroll into the OLE Phase. The OLE Phase will allow participants to receive active drug (abiraterone acetate plus prednisone) until Long-term Extension (LTE) Phase for an additional period of up to 3 years. Participants will discontinue study treatment at disease progression or unacceptable toxicity unless, in the Investigator's opinion, it is deemed that the participants will continue to derive benefit from study treatment. Participants will be randomized in a 1:1 ratio to the active treatment group (abiraterone acetate 1000 mg daily plus prednisone 5 mg daily plus ADT) or the control group (ADT plus placebos).Efficacy will be evaluated primarily by overall survival and radiographic progression-free survival. Participants' safety will be monitored throughout the study.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed metastatic prostate cancer within 3 months prior to randomization with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
  • Distant metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan
  • At least 2 of the following high-risk prognostic factors: Gleason score of greater than or equal to (>=8); presence of 3 or more lesions on bone scan; presence of measurable visceral (excluding lymph node disease) metastasis on CT or MRI Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 scan
  • Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2
  • Adequate hematologic, hepatic, and renal function
  • Agrees to protocol-defined use of effective contraception

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 mg prednisone per day
  • Pathological finding consistent with small cell carcinoma of the prostate
  • Known brain metastasis
  • Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer (the following exception are permitted): up to 3 months of androgen deprivation therapy (ADT) with lutenizing hormone releasing hormone agonists or antagonists or orchiectomy with or without concurrent anti-androgens prior Cycle 1 Day 1; participants may have one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 28 days prior to Cycle 1 Day 1)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715285

  Show 214 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01715285     History of Changes
Other Study ID Numbers: CR100900
212082PCR3011 ( Other Identifier: Janssen Research & Development, LLC )
2012-002940-26 ( EudraCT Number )
U1111-1135-7146 ( Other Identifier: Universal Trial Number )
Study First Received: October 24, 2012
Last Updated: May 30, 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:
Prostate neoplasms
Prostate cancer
Metastatic prostate cancer
Abiraterone acetate
ZYTIGA
Prednisone
Androgen deprivation therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Prednisone
Estrogens, Conjugated (USP)
Methyltestosterone
Abiraterone Acetate
Androgens
Ascorbic Acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors
Antioxidants
Protective Agents
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 23, 2017