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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)

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ClinicalTrials.gov Identifier: NCT01715285
Recruitment Status : Active, not recruiting
First Posted : October 26, 2012
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):

October 24, 2012
October 26, 2012
December 21, 2017
February 12, 2013
October 31, 2016   (Final data collection date for primary outcome measure)
  • 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.
Overall survival [ Time Frame: Up to the time of death from any cause (up to Month 60) ]
Complete list of historical versions of study NCT01715285 on ClinicalTrials.gov Archive Site
  • 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.
  • Radiographic progression-free survival [ Time Frame: Up to disease progression or death from any cause (up to 60 months after last dose of study drug) ]
  • Time to next skeletal-related event [ Time Frame: Up to 30 days after last dose of study drug ]
  • Time to prostate specific antigen progression [ Time Frame: Cycles 1-13 Day 1, Cycle 14 to end-of-treatment Day 1 up to disease progression ]
  • Time to next subsequent therapy for prostate cancer [ Time Frame: Up to 60 months after last dose of study drug ]
  • Time to initiation of chemotherapy [ Time Frame: Up to 60 months after last dose of study drug ]
  • Change in miRNA expression level [ Time Frame: Cycle 1 Day 1, Cycle 3 Day 1, and end-of-treatment up to 30 days of last dose of study drug ]
  • Change in mRNA expression level [ Time Frame: Cycle 1 Day 1, Cycle 3 Day 1, and end-of-treatment up to 30 days of last dose of study drug ]
  • Number of participants affected by an adverse event [ Time Frame: Up to 30 days after the last dose of study drug ]
Not Provided
Not Provided
 
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)
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)
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).
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Prostate Neoplasms
  • 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.
  • Drug: Prednisone Placebo
    Placebo matched to prednisone will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
  • 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.
    Interventions:
    • Drug: Abiraterone acetate
    • Drug: Prednisone
    • Other: Androgen deprivation therapy (ADT)
    • Drug: Abiraterone acetate Placebo
  • 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.
    Interventions:
    • Other: Androgen deprivation therapy (ADT)
    • Drug: Abiraterone acetate Placebo
    • Drug: Prednisone Placebo
Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Özgüroğlu M, Ye D, Feyerabend S, Protheroe A, De Porre P, Kheoh T, Park YC, Todd MB, Chi KN; LATITUDE Investigators. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2017 Jul 27;377(4):352-360. doi: 10.1056/NEJMoa1704174. Epub 2017 Jun 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1209
August 3, 2021
October 31, 2016   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Czechia,   Denmark,   Finland,   France,   Germany,   Hungary,   Israel,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Turkey,   Ukraine,   United Kingdom
Czech Republic,   Peru,   Singapore
 
NCT01715285
CR100900
212082PCR3011 ( Other Identifier: Janssen Research & Development, LLC )
2012-002940-26 ( EudraCT Number )
U1111-1135-7146 ( Other Identifier: Universal Trial Number )
Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP