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Study · Randomized controlled trial · n = 184 · 2024

4 results

Testosterone Recovery for Relugolix Versus Leuprolide in Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study.

Tutrone R, Saad F, George DJ, Tombal B, Bailen JL, Cookson MS, Saltzstein DR, Hanson S, Brown B, Lu S, Fallick M, Shore ND

European urology oncology23 Dec 2023Cited by 21 (Europe PMC)

PMID38143206 (opens in a new tab)DOI10.1016/j.euo.2023.11.024 (opens in a new tab)PepBankPUB-38143206
Publisher pagePubMedAsk about this study
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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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study4

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In men with prostate cancer, testosterone recovery above 280 ng/dl at 90 d was lower after leuprolide than relugolix (3.2% versus 54%; nominal p = 0.002).

    In plain wordsIn men with prostate cancer, testosterone recovery at 90 d was lower after leuprolide than relugolix.

    Peptide
    Leuprolide
    Outcome
    DecreaseTestosterone recovery above 280 ng/dl
    Study

    n = 184

    Comparator
    Relugolix
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    Dose not stated · injection · 48 wkAs given in this study (human).

    Measurements

    Cumulative incidence of testosterone recovery above 280 ng/dl at 90 d
    3.2%
    leuprolide acetate
    Cumulative incidence of testosterone recovery above 280 ng/dl at 90 d
    54%
    relugolix
    Nominal P value
    0.002
    relugolix versus leuprolide acetate

    Source sentences

    Summary
    The cumulative incidence rate of testosterone recovery to >280 ng/dl at 90 d following drug discontinuation was significantly higher in the relugolix cohort (n = 137) than in the leuprolide acetate cohort (n = 47; 54% vs 3.2%; nominal p = 0.002).
    2 context sentences
    Summary · context
    Men (N = 934) were randomized (2:1) to receive relugolix 120 mg orally daily or leuprolide acetate injections every 12 wk for 48 wk.
    Summary · context
    Testosterone recovery was assessed in 184 men who completed 48 wk of treatment.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In men with prostate cancer, median testosterone recovery time was 112.0 d after leuprolide versus 86.0 d after relugolix.

    In plain wordsIn men with prostate cancer, testosterone recovery took longer after leuprolide than relugolix.

    Peptide
    Leuprolide
    Outcome
    IncreaseMedian time to testosterone recovery
    Study

    n = 184

    Comparator
    Relugolix
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    Dose not stated · injection · 48 wkAs given in this study (human).

    Measurements

    Median time to testosterone recovery
    112 d
    leuprolide acetate
    Median time to testosterone recovery
    86 d
    relugolix

    Source sentences

    Summary
    The median time to testosterone recovery was faster following relugolix treatment than with leuprolide acetate treatment (86.0 d vs 112.0 d).
    2 context sentences
    Summary · context
    Men (N = 934) were randomized (2:1) to receive relugolix 120 mg orally daily or leuprolide acetate injections every 12 wk for 48 wk.
    Summary · context
    Testosterone recovery was assessed in 184 men who completed 48 wk of treatment.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In men with prostate cancer, 2.1% after leuprolide versus 39% after relugolix reached at least 80% of baseline testosterone.

    In plain wordsIn men with prostate cancer, fewer men reached at least 80% of baseline testosterone after leuprolide than relugolix.

    Peptide
    Leuprolide
    Outcome
    DecreaseRecovery to at least 80% of baseline testosterone
    Study

    n = 184

    Comparator
    Relugolix
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    Dose not stated · injection · 48 wkAs given in this study (human).

    Measurements

    Men reaching at least 80% of baseline testosterone
    2.1%
    leuprolide acetate
    Men reaching at least 80% of baseline testosterone
    39%
    relugolix

    Source sentences

    Summary
    Compared with leuprolide acetate, more men treated with relugolix achieved ≥80% of baseline testosterone levels (39% vs 2.1%).
    2 context sentences
    Summary · context
    Men (N = 934) were randomized (2:1) to receive relugolix 120 mg orally daily or leuprolide acetate injections every 12 wk for 48 wk.
    Summary · context
    Testosterone recovery was assessed in 184 men who completed 48 wk of treatment.
  4. 04HumanRandomized controlled trialSafety outcome

    In men with prostate cancer, adverse events were generally similar between leuprolide and relugolix groups.

    In plain wordsIn men with prostate cancer, adverse events were generally similar between leuprolide and relugolix groups.

    Peptide
    Leuprolide
    Outcome
    Direction not reportedAdverse events
    Study

    n = 184

    Comparator
    Relugolix
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    Dose not stated · injection · 48 wkAs given in this study (human).

    Source sentences

    Summary
    Adverse events were generally similar between treatment groups.
    2 context sentences
    Summary · context
    Men (N = 934) were randomized (2:1) to receive relugolix 120 mg orally daily or leuprolide acetate injections every 12 wk for 48 wk.
    Summary · context
    Testosterone recovery was assessed in 184 men who completed 48 wk of treatment.

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

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.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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