Skip to content

Study · Randomized controlled trial · n = 379 · 2025

5 results

Radiotherapy plus Long-term Adjuvant Androgen Deprivation with a Luteinizing Hormone-releasing Hormone Antagonist Versus Agonist in Patients with Very High-risk Localized or Locally Advanced Prostate Cancer: The EORTC GUCG-1414 Phase 3 Randomized Trial.

Zilli T, Böhmer D, Roeder A, Lauffer D, Villafranca Iturre AE, Jové-Teixidó JJ, Supiot S, Latorzeff I, Dirix P, Otte FX, Francolini G, Roumeguère T and 5 more

Show all authors

Simon JM, Fournier B, Fortpied C, Lara PC, Tombal B

European urology oncology7 Nov 2025Cited by 2 (Europe PMC)

PMID41206286 (opens in a new tab)DOI10.1016/j.euo.2025.10.009 (opens in a new tab)PepBankPUB-41206286
Publisher pagePubMedAsk about this study
Jump to 5 results

Summary

Background and objectiveExternal beam radiotherapy (EBRT) combined with long-term androgen deprivation therapy (ADT) is standard for high-risk prostate cancer. EORTC 1414 compared ADT with a luteinizing hormone-releasing hormone (LHRH) antagonist (degarelix) or an LHRH agonist in patients who received EBRT.MethodsBetween 2017 and 2023, 379 patients with prostate cancer with at least two high-risk features (prostate-specific antigen [PSA] ≥20 ng/ml, Gleason score ≥8, cN1, or cT3-4) and stage M0 on conventional imaging or stage M1a/b (n = ≤3 lesions) on advanced imaging were enrolled. Patients were randomized to receive 18, 24, or 36 mo of ADT (degarelix, n = 190; LHRH agonist, n = 189) with pelvic EBRT and treatment of all metastases. Owing to low accrual, the primary endpoint was changed from progression-free survival (PFS) to the PSA nadir response (<0.1 vs ≥0.1 ng/ml) within 6 mo after EBRT.Key findings and limitationsMedian age was 72 yr. A PSA nadir of <0.1 ng/ml was achieved by 60% of patients in the agonist arm and 52% in the degarelix arm (odds ratio 0.73, 95% confidence interval 0.43-1.22; p = 0.9). Two-year PFS was 88% in both arms. Adverse events occurred in 89% of agonist and 88% of degarelix patients. Among 41 patients with baseline cardiovascular (CV) disease, four in the agonist arm and one in the degarelix group experienced a CV event. Two CV-related deaths occurred in the agonist arm. Degarelix improved lower urinary tract symptoms, particularly in patients with a baseline International Prostate Symptom Score of ≥13. Limitations include early closure and insufficient power to assess PFS.Conclusions and clinical implicationsDegarelix did not improve the PSA nadir response within 6 mo after EBRT in comparison to LHRH agonists, but was associated with lower incidence of CV events among patients with pre-existing CV disease.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    After radiotherapy for prostate cancer, PSA nadir <0.1 ng/ml occurred in 52% with degarelix versus 60% with agonist (odds ratio 0.73, 95% CI 0.43-1.22; p = 0.9).

    In plain wordsDegarelix did not significantly improve PSA response compared with an LHRH agonist.

    Peptide
    Degarelix
    Outcome
    No significant changePSA nadir response
    Study

    n = 379

    Comparator
    LHRH agonist
    Analysis
    Primary
    Outcome group
    Tumor growth · Cancer
    Studied dose
    Dose not stated · 18, 24, or 36 monthsAs given in this study (human).

    Measurements

    PSA nadir <0.1 ng/ml response
    52%
    Degarelix arm, within 6 months after EBRT
    PSA nadir <0.1 ng/ml response
    60%
    LHRH agonist arm, within 6 months after EBRT
    Odds ratio for PSA nadir <0.1 ng/ml
    0.73 ratio
    Degarelix versus LHRH agonist; 95% CI 0.43-1.22

    Source sentences

    Summary
    A PSA nadir of <0.1 ng/ml was achieved by 60% of patients in the agonist arm and 52% in the degarelix arm (odds ratio 0.73, 95% confidence interval 0.43-1.22; p = 0.9).
    2 context sentences
    Summary · context
    EORTC 1414 compared ADT with a luteinizing hormone-releasing hormone (LHRH) antagonist (degarelix) or an LHRH agonist in patients who received EBRT.
    Summary · context
    Patients were randomized to receive 18, 24, or 36 mo of ADT (degarelix, n = 190; LHRH agonist, n = 189) with pelvic EBRT and treatment of all metastases.
  2. 02HumanRandomized controlled trialEfficacy outcome

    Two-year progression-free survival was 88% in both degarelix and agonist arms in prostate cancer.

    In plain wordsTwo-year progression-free survival was the same with degarelix and an LHRH agonist.

    Peptide
    Degarelix
    Outcome
    Not applicableTwo-year progression-free survival
    Study

    n = 379

    Comparator
    LHRH agonist
    Outcome group
    Tumor growth · Cancer
    Studied dose
    Dose not stated · 18, 24, or 36 monthsAs given in this study (human).

    Measurements

    Two-year progression-free survival
    88%
    Degarelix arm
    Two-year progression-free survival
    88%
    LHRH agonist arm

    Source sentences

    Summary
    Two-year PFS was 88% in both arms.
    2 context sentences
    Summary · context
    EORTC 1414 compared ADT with a luteinizing hormone-releasing hormone (LHRH) antagonist (degarelix) or an LHRH agonist in patients who received EBRT.
    Summary · context
    Patients were randomized to receive 18, 24, or 36 mo of ADT (degarelix, n = 190; LHRH agonist, n = 189) with pelvic EBRT and treatment of all metastases.
  3. 03HumanRandomized controlled trialSafety outcome

    Adverse events occurred in 88% with degarelix versus 89% with agonist in prostate cancer.

    In plain wordsAdverse events occurred in 88% with degarelix and 89% with an LHRH agonist.

    Peptide
    Degarelix
    Outcome
    Not applicableAdverse events
    Study

    n = 379

    Comparator
    LHRH agonist
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 18, 24, or 36 monthsAs given in this study (human).

    Measurements

    Adverse event rate
    88%
    Degarelix arm
    Adverse event rate
    89%
    LHRH agonist arm

    Source sentences

    Summary
    Adverse events occurred in 89% of agonist and 88% of degarelix patients.
    2 context sentences
    Summary · context
    EORTC 1414 compared ADT with a luteinizing hormone-releasing hormone (LHRH) antagonist (degarelix) or an LHRH agonist in patients who received EBRT.
    Summary · context
    Patients were randomized to receive 18, 24, or 36 mo of ADT (degarelix, n = 190; LHRH agonist, n = 189) with pelvic EBRT and treatment of all metastases.
  4. 04HumanRandomized controlled trialSafety outcome

    Among prostate cancer patients with baseline cardiovascular disease, one degarelix recipient versus four agonist recipients experienced a cardiovascular event.

    In plain wordsAmong patients with existing cardiovascular disease, fewer cardiovascular events occurred with degarelix than an LHRH agonist.

    Peptide
    Degarelix
    Outcome
    DecreaseCardiovascular events with baseline cardiovascular disease
    Study

    n = 41

    Comparator
    LHRH agonist
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    Dose not stated · 18, 24, or 36 monthsAs given in this study (human).

    Measurements

    Cardiovascular events
    1 patients
    Degarelix group, patients with baseline CV disease (41 total)
    Cardiovascular events
    4 patients
    LHRH agonist arm, patients with baseline CV disease (41 total)

    Source sentences

    Summary
    Among 41 patients with baseline cardiovascular (CV) disease, four in the agonist arm and one in the degarelix group experienced a CV event.
    2 context sentences
    Summary · context
    EORTC 1414 compared ADT with a luteinizing hormone-releasing hormone (LHRH) antagonist (degarelix) or an LHRH agonist in patients who received EBRT.
    Summary · context
    Patients were randomized to receive 18, 24, or 36 mo of ADT (degarelix, n = 190; LHRH agonist, n = 189) with pelvic EBRT and treatment of all metastases.
  5. 05HumanObservational studyEfficacy outcome

    Degarelix improved lower urinary tract symptoms in prostate cancer, particularly with baseline International Prostate Symptom Score ≥13.

    In plain wordsDegarelix improved urinary symptoms, particularly in patients with higher baseline symptom scores.

    Peptide
    Degarelix
    Outcome
    Direction not reportedLower urinary tract symptoms
    Study

    n: not reported in source

    Outcome group
    Urinary continence and bladder function · Kidney and urinary
    Studied dose
    Dose not stated · 18, 24, or 36 monthsAs given in this study (human).

    Source sentences

    Summary
    Degarelix improved lower urinary tract symptoms, particularly in patients with a baseline International Prostate Symptom Score of ≥13.
    2 context sentences
    Summary · context
    EORTC 1414 compared ADT with a luteinizing hormone-releasing hormone (LHRH) antagonist (degarelix) or an LHRH agonist in patients who received EBRT.
    Summary · context
    Patients were randomized to receive 18, 24, or 36 mo of ADT (degarelix, n = 190; LHRH agonist, n = 189) with pelvic EBRT and treatment of all metastases.

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, 16:34 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.