Clinical trialPhase 3Prostate cancer

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 · 20191199 patients

Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, et al. Lancet Oncol. 2019. 20:686-700

Study type: Clinical trial
Study name: LATITUDE
Phase: Phase 3
Design: Multicentre, randomised, double-blind, placebo-controlled trial (235 centres in 34 countries)
Sample size: 1199 patients
Source: Lancet Oncol · 2019
Trial registration: NCT01715285

In plain words

In this final analysis, men whose prostate cancer had already spread to the bones or other organs at diagnosis and who had high-risk features took abiraterone tablets with prednisone, or a placebo, on top of the usual hormone therapy. Adding abiraterone increased median survival from about 36.5 months to about 53.3 months. High blood pressure and low blood potassium were important side effects that need monitoring.

Key results

53.3 vs 36.5 months

Median overall survival

HR 0.66 (95% CI 0.56–0.78); p<0.0001

51.8 months

Median follow-up

618 deaths

21% vs 10%

Grade 3–4 hypertension

12% vs 2%

Grade 3–4 hypokalaemia

Drugs in this study:Abiraterone (Zytiga)

Dose and schedule cards

ADT + abiraterone + prednisone (LATITUDE)

mHSPC; in LATITUDE, newly diagnosed disease with at least 2 high-risk factors (Gleason ≥8, ≥3 bone lesions, measurable visceral metastases); ECOG 0 to 2Cycle length: ContinuousOn the page “Prostate cancer” · Metastatic hormone-sensitive disease (mHSPC)

mHSPC; in LATITUDE, newly diagnosed disease with at least 2 high-risk factors (Gleason ≥8, ≥3 bone lesions, measurable visceral metastases); ECOG 0 to 2

Drug	Dose	Route	Schedule
Abiraterone acetate	1000 mg once daily	Oral, fasting (no food for 2 h before and 1 h after the dose); swallow tablets whole	Daily
Prednisone	5 mg once daily	Oral	Daily
ADT (GnRH agonist or antagonist, or prior orchiectomy)	Per formulation	—	Continuous

Cycle length: Continuous
Duration: Until progression or unacceptable toxicity

Dose per the FDA label and the trial.

On the page “Prostate cancer” · Metastatic hormone-sensitive disease (mHSPC)

Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.

Treatment arms and regimens

1Abiraterone + prednisone + ADT

Abiraterone acetate 1000 mg orally once daily plus prednisone 5 mg orally once daily and androgen deprivation therapy (ADT); 28-day cycles.

2Placebo + ADT

Matching placebos plus ADT; after the first interim analysis, patients in the placebo group were allowed to cross over to abiraterone.

Source of the regimen details: ClinicalTrials.gov NCT01715285 and the abstract of the paper

Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.

Study population

Men aged 18 years or older with newly diagnosed metastatic prostate cancer, ECOG performance status 0 to 2 and at least two of three high-risk factors: Gleason score 8 or higher, three or more lesions on bone scan, or measurable visceral metastasis (excluding lymph nodes).

Endpoints

Overall survival (co-primary endpoint) in the intention-to-treat population; safety.

Safety and side effects

The most common grade 3–4 adverse events were hypertension (21% vs 10%) and hypokalaemia (12% vs 2%). Serious adverse events occurred in 32% versus 25%; treatment-related deaths numbered three in each group (less than 1%).

Clinical significance and place in guidelines

This final analysis confirmed the survival benefit of abiraterone plus prednisone and ADT in high-risk mCSPC despite crossover, and the authors considered it support for using this combination as standard treatment. Newer guidelines (such as ESMO 2026) recommend adding an ARPI to ADT in mCSPC.

Limitations

Only newly diagnosed patients with high-risk features were enrolled; after the interim analysis the study was unblinded and part of the placebo group crossed over to abiraterone. There was no comparison with docetaxel or other ARPIs.

Original article (DOI)PubMed ClinicalTrials.gov

This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.