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Study · Non-randomized trial · n = 134 · 2011

7 results

Efficacy and safety of androgen deprivation therapy after switching from monthly leuprolide to monthly degarelix in patients with prostate cancer.

de la Rosette J, Davis R 3rd, Frankel D, Kold Olesen T

International journal of clinical practice22 Feb 2011Cited by 16 (Europe PMC)

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 study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In prostate cancer patients switching to degarelix, testosterone, LH and PSA levels remained sustained in both dose groups.

    In plain wordsIn prostate cancer patients switching to degarelix, testosterone, LH and PSA levels remained sustained in both dose groups.

    Peptide
    Degarelix
    Outcome
    No significant changeMaintenance of testosterone, LH and PSA
    Study

    n = 134

    Comparator
    Before switch from leuprolide
    Outcome group
    Biochemical Disease Control · Cancer
    Studied dose
    240 mg initial, then 80 or 160 mg monthly · 3 monthsAs given in this study (human).

    Source sentences

    Summary
    Serum testosterone, LH, and PSA levels were all sustained in both treatment arms during the observation period.
    2 context sentences
    Summary · context
    Participants were 134 patients with histologically confirmed PCa who had completed 1 year of treatment with leuprolide 7.5 mg monthly before being switched to degarelix.
    Summary · context
    These patients were re-randomised for the extension trial to receive a starting dose of 240 mg degarelix followed by monthly maintenance doses of either 80 (n = 69) or 160 mg (n = 65).
  2. 02HumanNon-randomized trialEfficacy outcome

    In prostate cancer patients, switching from leuprolide to degarelix further reduced FSH by 30%.

    In plain wordsIn prostate cancer patients, switching from leuprolide to degarelix further reduced FSH by 30%.

    Peptide
    Degarelix
    Outcome
    DecreaseFSH reduction after switch
    Study

    n = 134

    Comparator
    Before switch from leuprolide
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    240 mg initial, then 80 or 160 mg monthly · 3 monthsAs given in this study (human).

    Measurements

    FSH reduction
    30%
    after switch to degarelix

    Source sentences

    Summary
    Interestingly, FSH levels were further decreased by 30% following the switch to degarelix.
    2 context sentences
    Summary · context
    Participants were 134 patients with histologically confirmed PCa who had completed 1 year of treatment with leuprolide 7.5 mg monthly before being switched to degarelix.
    Summary · context
    These patients were re-randomised for the extension trial to receive a starting dose of 240 mg degarelix followed by monthly maintenance doses of either 80 (n = 69) or 160 mg (n = 65).
  3. 03HumanNon-randomized trialSafety outcome

    In prostate cancer patients switching to degarelix, adverse event prevalence and pattern were comparable to prior leuprolide treatment, except injection site reactions.

    In plain wordsIn prostate cancer patients, adverse events were comparable after switching to degarelix from leuprolide, except injection site reactions.

    Peptide
    Degarelix
    Outcome
    No significant changeOverall adverse event prevalence and pattern
    Study

    n = 134

    Comparator
    Last 3 months of prior leuprolide treatment
    Outcome group
    Adverse events · Whole body
    Studied dose
    240 mg initial, then 80 or 160 mg monthly · 3 monthsAs given in this study (human).

    Source sentences

    Summary
    With the exception of injection site reactions, the overall prevalence and pattern of AEs during the first 3 months after the switch was comparable to that during the last 3 months leuprolide treatment in the main trial.
    2 context sentences
    Summary · context
    Participants were 134 patients with histologically confirmed PCa who had completed 1 year of treatment with leuprolide 7.5 mg monthly before being switched to degarelix.
    Summary · context
    These patients were re-randomised for the extension trial to receive a starting dose of 240 mg degarelix followed by monthly maintenance doses of either 80 (n = 69) or 160 mg (n = 65).
  4. 04HumanNon-randomized trialSafety outcome

    In prostate cancer patients switching to degarelix, injection site reactions were the exception to the comparable adverse event pattern during prior leuprolide treatment.

    In plain wordsIn prostate cancer patients, injection site reactions differed after switching from leuprolide to degarelix.

    Peptide
    Degarelix
    Outcome
    Direction not reportedInjection site reactions after switch
    Study

    n = 134

    Comparator
    Last 3 months of prior leuprolide treatment
    Outcome group
    Adverse events · Skin and wound
    Studied dose
    240 mg initial, then 80 or 160 mg monthly · 3 monthsAs given in this study (human).

    Source sentences

    Summary
    With the exception of injection site reactions, the overall prevalence and pattern of AEs during the first 3 months after the switch was comparable to that during the last 3 months leuprolide treatment in the main trial.
    2 context sentences
    Summary · context
    Participants were 134 patients with histologically confirmed PCa who had completed 1 year of treatment with leuprolide 7.5 mg monthly before being switched to degarelix.
    Summary · context
    These patients were re-randomised for the extension trial to receive a starting dose of 240 mg degarelix followed by monthly maintenance doses of either 80 (n = 69) or 160 mg (n = 65).
  5. 05HumanNon-randomized trialSafety outcome

    In prostate cancer patients receiving degarelix after leuprolide, five patients (4%) discontinued due to treatment-related adverse events.

    In plain wordsIn prostate cancer patients receiving degarelix after leuprolide, five patients discontinued due to treatment-related adverse events.

    Peptide
    Degarelix
    Outcome
    Not applicableTreatment-related adverse event discontinuations
    Study

    n = 134

    Outcome group
    Adverse events · Whole body
    Studied dose
    240 mg initial, then 80 or 160 mg monthly · 3 monthsAs given in this study (human).

    Measurements

    Treatment-related discontinuations
    5 patients
    treatment-related AEs
    Treatment-related discontinuations
    4%
    treatment-related AEs

    Source sentences

    Summary
    There were five (4%) patients discontinued to treatment-related AEs including injection site pain (n = 3) and fatigue (n = 2).
    2 context sentences
    Summary · context
    Participants were 134 patients with histologically confirmed PCa who had completed 1 year of treatment with leuprolide 7.5 mg monthly before being switched to degarelix.
    Summary · context
    These patients were re-randomised for the extension trial to receive a starting dose of 240 mg degarelix followed by monthly maintenance doses of either 80 (n = 69) or 160 mg (n = 65).
  6. 06HumanNon-randomized trialSafety outcome

    In prostate cancer patients receiving degarelix after leuprolide, injection site pain caused discontinuation in 3 patients.

    In plain wordsIn prostate cancer patients receiving degarelix after leuprolide, injection site pain caused discontinuation in 3 patients.

    Peptide
    Degarelix
    Outcome
    Not applicableInjection site pain leading to discontinuation
    Study

    n = 134

    Outcome group
    Adverse events · Skin and wound
    Studied dose
    240 mg initial, then 80 or 160 mg monthly · 3 monthsAs given in this study (human).

    Measurements

    Injection site pain discontinuations
    3 patients
    degarelix

    Source sentences

    Summary
    There were five (4%) patients discontinued to treatment-related AEs including injection site pain (n = 3) and fatigue (n = 2).
    2 context sentences
    Summary · context
    Participants were 134 patients with histologically confirmed PCa who had completed 1 year of treatment with leuprolide 7.5 mg monthly before being switched to degarelix.
    Summary · context
    These patients were re-randomised for the extension trial to receive a starting dose of 240 mg degarelix followed by monthly maintenance doses of either 80 (n = 69) or 160 mg (n = 65).
  7. 07HumanNon-randomized trialSafety outcome

    In prostate cancer patients receiving degarelix after leuprolide, fatigue caused discontinuation in 2 patients.

    In plain wordsIn prostate cancer patients receiving degarelix after leuprolide, fatigue caused discontinuation in 2 patients.

    Peptide
    Degarelix
    Outcome
    Not applicableFatigue leading to discontinuation
    Study

    n = 134

    Outcome group
    Adverse events · Whole body
    Studied dose
    240 mg initial, then 80 or 160 mg monthly · 3 monthsAs given in this study (human).

    Measurements

    Fatigue discontinuations
    2 patients
    degarelix

    Source sentences

    Summary
    There were five (4%) patients discontinued to treatment-related AEs including injection site pain (n = 3) and fatigue (n = 2).
    2 context sentences
    Summary · context
    Participants were 134 patients with histologically confirmed PCa who had completed 1 year of treatment with leuprolide 7.5 mg monthly before being switched to degarelix.
    Summary · context
    These patients were re-randomised for the extension trial to receive a starting dose of 240 mg degarelix followed by monthly maintenance doses of either 80 (n = 69) or 160 mg (n = 65).

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 3Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 2

    27 Oct 2026, 16:37 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    27 Oct 2026, 16:34 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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