Study version 1 · Published 2026-09-20

NCT03085095: preserved study context

This version preserves its selected source observations and article-review references. Open the current study collection →

Oncology · Phase 3

HERO: androgen suppression in prostate cancer

NCT03085095 ↗

Leuprolide

What was tested?

Relugolix versus leuprolide in men with advanced prostate cancer; leuprolide was the active comparator. ↗

Registered primary question: Sustained testosterone suppression from day 29 through day 337. ↗

What the reviewed report found

Journal year 2020 · Article summary reviewed 2026-09-20

Sustained testosterone suppression was reported for 96.7% of the relugolix group and 88.8% of the leuprolide group, meeting the trial's noninferiority and superiority criteria for that endpoint.↗

Keep in context: The paper describes 930 treated participants, while the registry lists 1,134 enrolled across the registered study. The primary endpoint concerns testosterone suppression rather than cancer survival. ↗↗

Participants, design, limitations and sources

Registry snapshot

Registry enrollment
1,134 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Open label
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Posted in this snapshot

Registry source ↗ · Updated 2022-01-18; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.

HERO androgen-deprivation trial

Design in the report
A sponsor-funded, randomized Phase 3 trial compared oral relugolix with leuprolide for 48 weeks; sustained testosterone suppression was the primary endpoint.↗
Participants in the report
The report describes 930 men with advanced prostate cancer who received treatment: 622 received relugolix and 308 received leuprolide. These are treated-participant counts, not a stated count of everyone randomized.↗
Limitations
Leuprolide was the comparator, not the experimental treatment, and the primary result concerned testosterone suppression rather than cancer progression or survival.↗

This reading covers the article abstract and record metadata. Read its preserved Human Evidence Review →

How the study identity and sources were checked

Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.

Registry

A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer ↗
Protocol identifier: MVT-601-3201. Sponsor: Myovant Sciences GmbH.
Retrieved 2026-09-20; SHA-256 1d2bc0c45eccceb3b1b80915f7bbc5420736a661ae1b7b89d1fc1baab9afbf6f.

PMID 32469183

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

Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference BACKGROUND. These source labels do not establish that every result in a paper applies to this trial.

Identity metadata retrieved 2026-09-20. EFetch batch XML; locate MedlineCitation/PMID 32469183. SHA-256 b9b2737876819a52052ecd9dc7208be1ad5712f7a133c5c13d04f6663f02d118.

Scientific summary uses the original 2026-09-20 source snapshot: SHA-256 ff23e8f570d660744b13fbe1420af8f24b062e1dad2ce2b36eee4e240dd2a36b.