Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer.

Shore ND, Saad F, Cookson MS, George DJ, Saltzstein DR, Tutrone R, Akaza H, Bossi A, van Veenhuyzen DF, Selby B, Fan X, Kang V, Walling J, Tombal B

The New England journal of medicine29 May 2020Cited by 346 (Europe PMC)

PMID32469183DOI10.1056/nejmoa2004325PepBankPUB-32469183

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In men with advanced prostate cancer, sustained castration occurred in 88.8% with leuprolide versus 96.7% with relugolix.
In plain wordsIn men with advanced prostate cancer, sustained testosterone suppression was less frequent with leuprolide than relugolix.
Peptide
Leuprolide
Outcome
DecreaseSustained testosterone suppression
Study
n = 930
Comparator
Relugolix
Analysis
Primary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · injection every 3 months · 48 weeksAs given in this study (human).
Measurements
Sustained castration
88.8%
leuprolide
95% CI range
84.6 to 91.8%
leuprolide
Sustained castration
96.7%
relugolix
95% CI range
94.9 to 97.9%
relugolix
Difference
7.9 percentage points
relugolix minus leuprolide
95% CI range
4.1 to 11.8 percentage points
difference
P for superiority
< 0.001
relugolix vs leuprolide
Source sentences
Summary
Of men who received relugolix, 96.7% (95% confidence interval [CI], 94.9 to 97.9) maintained castration through 48 weeks, as compared with 88.8% (95% CI, 84.6 to 91.8) of men receiving leuprolide.
2 context sentences(design, population, supporting numbers)
Summary · context
The difference of 7.9 percentage points (95% CI, 4.1 to 11.8) showed noninferiority and superiority of relugolix (P<0.001 for superiority).
Summary · context
In this phase 3 trial, we randomly assigned patients with advanced prostate cancer, in a 2:1 ratio, to receive relugolix (120 mg orally once daily) or leuprolide (injections every 3 months) for 48 weeks.
Report a problemFND-3246918301
02HumanRandomized controlled trialEfficacy outcome
In men with advanced prostate cancer, day 4 castrate testosterone occurred in 0% with leuprolide versus 56.0% with relugolix.
In plain wordsIn men with advanced prostate cancer, day 4 testosterone suppression was less frequent with leuprolide than relugolix.
Peptide
Leuprolide
Outcome
DecreaseCastrate testosterone on day 4
Study
n = 930
Comparator
Relugolix
Analysis
Secondary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · injection every 3 months · 48 weeksAs given in this study (human).
Measurements
Castrate testosterone on day 4
0%
leuprolide
Castrate testosterone on day 4
56%
relugolix
Source sentences
Summary
The percentage of patients with castrate levels of testosterone on day 4 was 56.0% with relugolix and 0% with leuprolide.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3 trial, we randomly assigned patients with advanced prostate cancer, in a 2:1 ratio, to receive relugolix (120 mg orally once daily) or leuprolide (injections every 3 months) for 48 weeks.
Report a problemFND-3246918302
03HumanRandomized controlled trialSafety outcome
In men with advanced prostate cancer, major cardiovascular events occurred in 6.2% with leuprolide versus 2.9% with relugolix.
In plain wordsIn men with advanced prostate cancer, major cardiovascular events were more frequent with leuprolide than relugolix.
Peptide
Leuprolide
Outcome
IncreaseMajor adverse cardiovascular events
Study
n = 930
Comparator
Relugolix
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
Dose not stated · injection every 3 months · 48 weeksAs given in this study (human).
Measurements
MACE
6.2%
leuprolide
MACE
2.9%
relugolix
Hazard ratio
0.46
relugolix versus leuprolide
95% CI
0.24 to 0.88
hazard ratio
Source sentences
Summary
Among all the patients, the incidence of major adverse cardiovascular events was 2.9% in the relugolix group and 6.2% in the leuprolide group (hazard ratio, 0.46; 95% CI, 0.24 to 0.88).
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3 trial, we randomly assigned patients with advanced prostate cancer, in a 2:1 ratio, to receive relugolix (120 mg orally once daily) or leuprolide (injections every 3 months) for 48 weeks.
Report a problemFND-3246918305
04HumanRandomized controlled trialEfficacy outcome
In men followed for testosterone recovery, mean testosterone at 90 days after discontinuation was 58.6 ng per deciliter with leuprolide versus 288.4 with relugolix.
In plain wordsAfter treatment ended, testosterone recovery was lower with leuprolide than relugolix in men with prostate cancer.
Peptide
Leuprolide
Outcome
DecreaseTestosterone recovery after discontinuation
Study
n = 184
Comparator
Relugolix
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · injection every 3 months · 48 weeksAs given in this study (human).
Measurements
Mean testosterone 90 days after discontinuation
58.6 ng per deciliter
leuprolide
Mean testosterone 90 days after discontinuation
288.4 ng per deciliter
relugolix
Source sentences
Summary
In the subgroup of 184 patients followed for testosterone recovery, the mean testosterone levels 90 days after treatment discontinuation were 288.4 ng per deciliter in the relugolix group and 58.6 ng per deciliter in the leuprolide group.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 3 trial, we randomly assigned patients with advanced prostate cancer, in a 2:1 ratio, to receive relugolix (120 mg orally once daily) or leuprolide (injections every 3 months) for 48 weeks.
Report a problemFND-3246918304

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 1 not yet recruiting · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

Not yet recruitingPhase not statedNCT07460726

PRIAPUS-PCa Study: Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (ADT) Impact on Sexual Function on Men With Unfavorable Intermediate Risk Prostate Cancer

CancerCare Manitoban = 130est. 16 Mar 2026 to est. 31 Dec 2029

Prostate Cancer (Adenocarcinoma) · Erectile Abnormalities · Sexual Dysfunction Male

Trial page ClinicalTrials.govUpdated 10 Mar 2026

CompletedPhase 3Results postedNCT03085095

A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer

Myovant Sciences GmbHn = 1,13418 Apr 2017 to 26 Nov 2021

Prostate Cancer

Trial page ClinicalTrials.govUpdated 18 Jan 2022

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

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