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NCT01715285 · CITED IN SOURCE DOCUMENTS

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)

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2025-02-04

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 plus low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone \[LHRH\] agonists or surgical castration).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Radiographic Progression-Free Survival (PFS)

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Time to Initiation of Chemotherapy

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outcome · POSTED

Time to Subsequent Therapy for Prostate Cancer

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outcome · POSTED

Time to Pain Progression

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outcome · POSTED

Time to Skeletal-Related Event

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outcome · POSTED

Time to Prostate-Specific Antigen (PSA) Progression

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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)
healthy Volunteers
false
minimum Age
18 Years
sex
MALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants will receive abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 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.
    intervention Names
    1. Drug: Abiraterone acetate
    2. Drug: Prednisone
    3. Other: Androgen deprivation therapy (ADT)
    label
    Abiraterone acetate + Prednisone + ADT
    type
    EXPERIMENTAL
  2. description
    Participants will receive placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT will be administered.
    intervention Names
    1. Other: Androgen deprivation therapy (ADT)
    2. Drug: Abiraterone acetate Placebo
    3. Drug: Prednisone Placebo
    label
    Placebo + Androgen Deprivation Therapy (ADT)
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Abiraterone acetate + Prednisone + ADT
    description
    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.
    name
    Abiraterone acetate
    other Names
    1. Zytiga
    type
    DRUG
  2. arm Group Labels
    1. Abiraterone acetate + Prednisone + ADT
    description
    Prednisone 5 mg capsule will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
    name
    Prednisone
    type
    DRUG
  3. arm Group Labels
    1. Abiraterone acetate + Prednisone + ADT
    2. Placebo + Androgen Deprivation Therapy (ADT)
    description
    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.
    name
    Androgen deprivation therapy (ADT)
    type
    OTHER
  4. arm Group Labels
    1. Placebo + Androgen Deprivation Therapy (ADT)
    description
    Placebo matched to abiraterone acetate will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
    name
    Abiraterone acetate Placebo
    type
    DRUG
  5. arm Group Labels
    1. Placebo + Androgen Deprivation Therapy (ADT)
    description
    Placebo matched to prednisone will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
    name
    Prednisone Placebo
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
TRIPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
primary Purpose
TREATMENT
Enrollment
count
1209
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Radiographic PFS was defined as the time (in months) interval from randomization to the first date of radiographic progression or death. Radiographic progression included progression by bone scan (according to modified Prostate Cancer Working Group 2 \[PCWG2\] criteria), defined as at least 2 new lesions on bone scan and progression of soft tissue lesions by computed tomography (CT) or magnetic resonance imaging (MRI) (according to Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 criteria). As per the RECIST 1.1 guideline, progression requires a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum as compared to nadir sum of diameter.
    measure
    Radiographic Progression-Free Survival (PFS)
    time Frame
    Up to 44 months
  2. description
    Overall survival was defined as the time from randomization to date of death from any cause.
    measure
    Overall Survival (OS)
    time Frame
    Up to 66 months
secondary Outcomes
  1. description
    Time to initiation of chemotherapy was defined as the time (in months) interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.
    measure
    Time to Initiation of Chemotherapy
    time Frame
    Up to 66 months
  2. description
    Time to subsequent therapy was defined as the time (in months) interval from the date of randomization to the date of initiation of subsequent therapy for prostate cancer.
    measure
    Time to Subsequent Therapy for Prostate Cancer
    time Frame
    Up to 66 months
  3. description
    Time to pain progression was defined as the time (in months) interval from randomization to the first date a participant experienced a greater than or equal to (\>=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (\>=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing "no pain" and 10 representing" pain as bad as you can imagine.
    measure
    Time to Pain Progression
    time Frame
    Up to 66 months
  4. description
    Time to skeletal-related event was defined as the earliest of the following: clinical or pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone.
    measure
    Time to Skeletal-Related Event
    time Frame
    Up to 66 months
  5. description
    Time to PSA progression was defined as the time (in months) interval from the date of randomization to the date of PSA progression, according to PCWG2 criteria. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.
    measure
    Time to Prostate-Specific Antigen (PSA) Progression
    time Frame
    Up to 66 months
Full study description
brief Summary
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 plus low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone \[LHRH\] agonists or surgical castration).
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 plus 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 \[mg\] plus 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.
Source references
references
  1. citation
    Koroki Y, Taguri M. Clinical Outcomes of First Subsequent Therapies After Abiraterone Acetate Plus Prednisone for High-Risk Metastatic Castration-Sensitive Prostate Cancer in the LATITUDE Study. Target Oncol. 2023 Jan;18(1):119-128. doi: 10.1007/s11523-022-00929-3. Epub 2022 Nov 28.
    pmid
    36443540
    type
    DERIVED
  2. citation
    Koroki Y, Taguri M, Matsubara N, Fizazi K. Estimation of Overall Survival with Subsequent Treatment Effect by Applying Inverse Probability of Censoring Weighting in the LATITUDE Study. Eur Urol Open Sci. 2022 Jan 6;36:51-58. doi: 10.1016/j.euros.2021.11.012. eCollection 2022 Feb.
    pmid
    35098170
    type
    DERIVED
  3. citation
    Baciarello G, Ozguroglu M, Mundle S, Leitz G, Richarz U, Hu P, Feyerabend S, Matsubara N, Chi KN, Fizazi K. Impact of abiraterone acetate plus prednisone in patients with castration-sensitive prostate cancer and visceral metastases over four years of follow-up: A post-hoc exploratory analysis of the LATITUDE study. Eur J Cancer. 2022 Feb;162:56-64. doi: 10.1016/j.ejca.2021.11.026. Epub 2021 Dec 23.
    pmid
    34953443
    type
    DERIVED
  4. citation
    Azad AA, Armstrong AJ, Alcaraz A, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Alekseev B, Iguchi T, Shore ND, Gomez-Veiga F, Rosbrook B, Lee HJ, Haas GP, Stenzl A. Efficacy of enzalutamide in subgroups of men with metastatic hormone-sensitive prostate cancer based on prior therapy, disease volume, and risk. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):274-282. doi: 10.1038/s41391-021-00436-y. Epub 2021 Aug 21.
    pmid
    34420037
    type
    DERIVED
  5. citation
    Feyerabend S, Saad F, Perualila NJ, Van Sanden S, Diels J, Ito T, De Porre P, Fizazi K. Adjusting Overall Survival Estimates for Treatment Switching in Metastatic, Castration-Sensitive Prostate Cancer: Results from the LATITUDE Study. Target Oncol. 2019 Dec;14(6):681-688. doi: 10.1007/s11523-019-00685-x.
    pmid
    31754962
    type
    DERIVED
  6. citation
    Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Ozguroglu M, Ye D, Feyerabend S, Protheroe A, Sulur G, Luna Y, Li S, Mundle S, Chi KN. Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial. Lancet Oncol. 2019 May;20(5):686-700. doi: 10.1016/S1470-2045(19)30082-8. Epub 2019 Apr 12.
    pmid
    30987939
    type
    DERIVED
  7. citation
    Li T, Franco-Villalobos C, Proskorovsky I, Sorensen SV, Tran N, Sulur G, Chi KN. Medical resource utilization of abiraterone acetate plus prednisone added to androgen deprivation therapy in metastatic castration-naive prostate cancer: Results from LATITUDE. Cancer. 2019 Feb 15;125(4):626-632. doi: 10.1002/cncr.31847. Epub 2018 Dec 6.
    pmid
    30521063
    type
    DERIVED
  8. citation
    Chi KN, Protheroe A, Rodriguez-Antolin A, Facchini G, Suttman H, Matsubara N, Ye Z, Keam B, Damiao R, Li T, McQuarrie K, Jia B, De Porre P, Martin J, Todd MB, Fizazi K. Patient-reported outcomes following abiraterone acetate plus prednisone added to androgen deprivation therapy in patients with newly diagnosed metastatic castration-naive prostate cancer (LATITUDE): an international, randomised phase 3 trial. Lancet Oncol. 2018 Feb;19(2):194-206. doi: 10.1016/S1470-2045(17)30911-7. Epub 2018 Jan 8.
    pmid
    29326030
    type
    DERIVED
  9. citation
    Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Ozguroglu 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.
    pmid
    28578607
    type
    DERIVED
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        orted by a delay in patient reported pain progression favoring the ZYTIGA arm. Figure 2 Figure 3 LATITUDE: Patients with metastatic high-risk CSPC In LATITUDE (NCT01715285), 1199 patients with metastatic high-risk CSPC were randomized 1:1 to receive either ZYTIGA orally at a dose of 1,000 mg once daily with prednisone 5 mg once d
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        alone. </p> <div class="pdq-content-list"><ol id="_3002"><li> In the randomized double-blind <a href="/clinicaltrials/NCT01715285">LATITUDE</a> trial (NCT01715285), 1,199 men with high-risk metastatic castration-sensitive prostate cancer were given ADT plus either abiraterone acetate (1,000 mg PO qd) and prednisone (5 mg
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        Updated: May 14, 2025
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    Preserved source evidence · Not medical advice