Phase 3
Completed N=1,199
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)
Source: ClinicalTrials.gov NCT01715285 ↗Enrolled (actual)
1,199
Serious AEs
27.3%
Results posted
Oct 2018
Primary outcomePrimary: Radiographic Progression-Free Survival (PFS) — 33.02; 14.78 Months — p=<0.0001
◆ Published Evidence
Established
29citations · ~7 / year
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.
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).
Linked Publications (5)
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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.
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Efficacy of enzalutamide in subgroups of men with metastatic hormone-sensitive prostate cancer based on prior therapy, disease volume, and risk.
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Adjusting Overall Survival Estimates for Treatment Switching in Metastatic, Castration-Sensitive Prostate Cancer: Results from the LATITUDE Study.
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Clinical Outcomes of First Subsequent Therapies After Abiraterone Acetate Plus Prednisone for High-Risk Metastatic Castration-Sensitive Prostate Cancer in the LATITUDE Study.
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Estimation of Overall Survival with Subsequent Treatment Effect by Applying Inverse Probability of Censoring Weighting in the LATITUDE Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiographic Progression-Free Survival (PFS) |
33.02; 14.78 | <0.0001 sig |
| PRIMARY Overall Survival (OS) |
53.32; 36.53 | < 0.0001 sig |
| SECONDARY Time to Initiation of Chemotherapy |
NA; 57.59 | — |
| SECONDARY Time to Subsequent Therapy for Prostate Cancer |
54.87; 21.22 | — |
| SECONDARY Time to Pain Progression |
47.41; 16.62 | — |
| SECONDARY Time to Skeletal-Related Event |
NA; NA | — |
| SECONDARY Time to Prostate-Specific Antigen (PSA) Progression |
33.31; 7.43 | — |
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)
Data sourced from ClinicalTrials.gov (NCT01715285) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.