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Study · Randomized controlled trial · n = 52 · 2004

9 results

Bicalutamide monotherapy versus leuprolide monotherapy for prostate cancer: effects on bone mineral density and body composition.

Smith MR, Goode M, Zietman AL, McGovern FJ, Lee H, Finkelstein JS

Journal of clinical oncology : official journal of the American Society of Clinical Oncology1 Jul 2004Cited by 130 (Europe PMC)

PMID15226323 (opens in a new tab)DOI10.1200/jco.2004.01.174 (opens in a new tab)PepBankPUB-15226323
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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 study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In men with prostate cancer, lumbar spine bone density decreased 2.5% with leuprolide but increased with bicalutamide over 12 months.

    In plain wordsMen with prostate cancer lost lumbar spine bone density with leuprolide, while density increased with bicalutamide.

    Peptide
    Leuprolide
    Outcome
    DecreasePosterior-anterior lumbar spine bone mineral density
    Study

    n = 52

    Comparator
    Bicalutamide monotherapy
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 12 monthsAs given in this study (human).

    Measurements

    Bone mineral density change
    −2.5%
    leuprolide, baseline to 12 months
    Standard error
    0.5%
    leuprolide
    Bone mineral density increase
    2.5
    bicalutamide, baseline to 12 months; unit not repeated in source
    Standard error
    0.5
    bicalutamide; unit not repeated in source
    P value
    < 0.001
    between groups

    Source sentences

    Summary
    Mean (+/- standard error) bone mineral density of the posterior-anterior lumbar spine decreased by 2.5% +/- 0.5% in the leuprolide group and increased by 2.5 +/- 0.5 in the bicalutamide group from baseline to 12 months (P <.001).
    1 context sentence
    Summary · context
    In a 12-month, open-label study, we randomly assigned 52 men with prostate cancer and no bone metastases to receive either leuprolide or bicalutamide (150 mg by mouth daily).
  2. 02HumanRandomized controlled trialActivity measurement

    In men with prostate cancer, bone density changes at four other sites differed significantly between leuprolide and bicalutamide, without stated directions.

    In plain wordsBone density changes at four other sites differed significantly between leuprolide and bicalutamide in men with prostate cancer.

    Peptide
    Leuprolide
    Outcome
    Direction not reportedTotal body, total hip, femoral neck, and lumbar trabecular bone density changes
    Study

    n = 52

    Comparator
    Bicalutamide monotherapy
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 12 monthsAs given in this study (human).

    Measurements

    P value
    ≤ 0.003
    each of the four site comparisons

    Source sentences

    Summary
    Mean changes in bone mineral density of the total body, total hip, femoral neck, and trabecular bone of the lumbar spine also differed significantly between groups (P < or =.003 for each comparison).
    1 context sentence
    Summary · context
    In a 12-month, open-label study, we randomly assigned 52 men with prostate cancer and no bone metastases to receive either leuprolide or bicalutamide (150 mg by mouth daily).
  3. 03HumanRandomized controlled trialSafety outcome

    In men with prostate cancer, fat mass increased 11.1% with leuprolide versus 6.4% with bicalutamide.

    In plain wordsMen with prostate cancer gained more fat with leuprolide than with bicalutamide.

    Peptide
    Leuprolide
    Outcome
    IncreaseFat mass
    Study

    n = 52

    Comparator
    Bicalutamide monotherapy
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 12 monthsAs given in this study (human).

    Measurements

    Fat mass increase
    11.1%
    leuprolide
    Standard error
    1.3%
    leuprolide
    Fat mass increase
    6.4%
    bicalutamide
    Standard error
    1.1%
    bicalutamide
    P value
    0.01
    between groups

    Source sentences

    Summary
    Fat mass increased by 11.1% +/- 1.3% in the leuprolide group and by 6.4% +/- 1.1% in the bicalutamide group (P =.01).
    1 context sentence
    Summary · context
    In a 12-month, open-label study, we randomly assigned 52 men with prostate cancer and no bone metastases to receive either leuprolide or bicalutamide (150 mg by mouth daily).
  4. 04HumanRandomized controlled trialActivity measurement

    In men with prostate cancer, changes in lean mass, muscle size, and muscle strength were similar with leuprolide and bicalutamide.

    In plain wordsChanges in lean mass, muscle size, and muscle strength were similar with leuprolide and bicalutamide in men with prostate cancer.

    Peptide
    Leuprolide
    Outcome
    No significant changeLean mass, muscle size, and muscle strength changes
    Study

    n = 52

    Comparator
    Bicalutamide monotherapy
    Outcome group
    Body composition · Musculoskeletal
    Studied dose
    Dose not stated · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    Changes in lean mass, muscle size, and muscle strength were similar between the groups.
    1 context sentence
    Summary · context
    In a 12-month, open-label study, we randomly assigned 52 men with prostate cancer and no bone metastases to receive either leuprolide or bicalutamide (150 mg by mouth daily).
  5. 05HumanRandomized controlled trialSafety outcome

    In men with prostate cancer, breast tenderness was less common with leuprolide than with bicalutamide.

    In plain wordsBreast tenderness was less common with leuprolide than with bicalutamide in men with prostate cancer.

    Peptide
    Leuprolide
    Outcome
    DecreaseBreast tenderness
    Study

    n = 52

    Comparator
    Bicalutamide monotherapy
    Outcome group
    Adverse events · Reproductive and sexual health
    Studied dose
    Dose not stated · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    Breast tenderness and enlargement were more common in the bicalutamide group than in the leuprolide group.
    1 context sentence
    Summary · context
    In a 12-month, open-label study, we randomly assigned 52 men with prostate cancer and no bone metastases to receive either leuprolide or bicalutamide (150 mg by mouth daily).
  6. 06HumanRandomized controlled trialSafety outcome

    In men with prostate cancer, breast enlargement was less common with leuprolide than with bicalutamide.

    In plain wordsBreast enlargement was less common with leuprolide than with bicalutamide in men with prostate cancer.

    Peptide
    Leuprolide
    Outcome
    DecreaseBreast enlargement
    Study

    n = 52

    Comparator
    Bicalutamide monotherapy
    Outcome group
    Adverse events · Reproductive and sexual health
    Studied dose
    Dose not stated · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    Breast tenderness and enlargement were more common in the bicalutamide group than in the leuprolide group.
    1 context sentence
    Summary · context
    In a 12-month, open-label study, we randomly assigned 52 men with prostate cancer and no bone metastases to receive either leuprolide or bicalutamide (150 mg by mouth daily).
  7. 07HumanRandomized controlled trialSafety outcome

    In men with prostate cancer, fatigue was more common with leuprolide than with bicalutamide.

    In plain wordsFatigue was more common with leuprolide than with bicalutamide in men with prostate cancer.

    Peptide
    Leuprolide
    Outcome
    IncreaseFatigue
    Study

    n = 52

    Comparator
    Bicalutamide monotherapy
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    Fatigue, loss of sexual interest, and vasomotor flushing were less common in the bicalutamide group than in the leuprolide group.
    1 context sentence
    Summary · context
    In a 12-month, open-label study, we randomly assigned 52 men with prostate cancer and no bone metastases to receive either leuprolide or bicalutamide (150 mg by mouth daily).
  8. 08HumanRandomized controlled trialSafety outcome

    In men with prostate cancer, loss of sexual interest was more common with leuprolide than with bicalutamide.

    In plain wordsLoss of sexual interest was more common with leuprolide than with bicalutamide in men with prostate cancer.

    Peptide
    Leuprolide
    Outcome
    IncreaseLoss of sexual interest
    Study

    n = 52

    Comparator
    Bicalutamide monotherapy
    Outcome group
    Sexual function · Reproductive and sexual health
    Studied dose
    Dose not stated · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    Fatigue, loss of sexual interest, and vasomotor flushing were less common in the bicalutamide group than in the leuprolide group.
    1 context sentence
    Summary · context
    In a 12-month, open-label study, we randomly assigned 52 men with prostate cancer and no bone metastases to receive either leuprolide or bicalutamide (150 mg by mouth daily).
  9. 09HumanRandomized controlled trialSafety outcome

    In men with prostate cancer, vasomotor flushing was more common with leuprolide than with bicalutamide.

    In plain wordsFlushing was more common with leuprolide than with bicalutamide in men with prostate cancer.

    Peptide
    Leuprolide
    Outcome
    IncreaseVasomotor flushing
    Study

    n = 52

    Comparator
    Bicalutamide monotherapy
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    Dose not stated · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    Fatigue, loss of sexual interest, and vasomotor flushing were less common in the bicalutamide group than in the leuprolide group.
    1 context sentence
    Summary · context
    In a 12-month, open-label study, we randomly assigned 52 men with prostate cancer and no bone metastases to receive either leuprolide or bicalutamide (150 mg by mouth daily).

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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