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Peptide

Goserelin (Zoladex)

Goserelin is a synthetic decapeptide GnRH agonist. FDA-approved in 1989, it is used for prostate cancer, breast cancer, and endometriosis. Clinical trials show 82% objective response in metastatic prostate cancer and 10-year survival rates of 42-87% depending on setting. Available as 3.6mg (monthly) and 10.8mg (3-month) subcutaneous implants.

Research notice. This page is for education and research. Peptides may not be FDA-approved for human use and may only be legally available for research. Talk to a qualified clinician before considering any peptide.

Best evidence
Grade A
Conditions studied
2
Outcomes
11
Graded outcomes
6230

Evidence by condition

  • Strong
  • Moderate
  • Limited
  • Very limited

2 conditions, plus general outcomes

Breast Cancer

Breast Cancer: outcomes studied for Goserelin (Zoladex)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Disease Control (Breast)

Effective for HR-positive breast cancer. Monthly and 3-monthly formulations show equivalent efficacy.

Improves (the measure goes up)Moderate effect9 studies

Studies that measured disease control (breast)

Ovarian Function Suppression

Preferred option for OFS in premenopausal breast cancer. Established safety profile in clinical trials.

Improves (the measure goes down)Large effect4 studies

Studies that measured ovarian function suppression

Estrogen Suppression

Achieves effective estrogen suppression in premenopausal women for hormone receptor-positive breast cancer.

Improves (the measure goes down)Large effect4 studies

Studies that measured estrogen suppression

Prostate Cancer

Prostate Cancer: outcomes studied for Goserelin (Zoladex)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Testosterone Suppression

Achieves T ≤50 ng/dL in 1 month, ≤20 ng/dL in 3 months. Lower testosterone escape rates compared to some GnRH agonists.

Improves (the measure goes down)Large effect5 studies

Studies that measured testosterone suppression

PSA Suppression

Maximum benefit in PSA suppression among GnRH agonists. 82% objective response rate in metastatic disease.

Improves (the measure goes down)Large effect5 studies

Studies that measured psa suppression

Overall Survival (Prostate)

10-year OS 42.6-86% neoadjuvant, 87% adjuvant to prostatectomy, 49% absolute survival adjuvant to radiotherapy.

Improves (the measure goes up)Large effect5 studies

Studies that measured overall survival (prostate)

General

General: outcomes studied for Goserelin (Zoladex)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Anti-Cancer Activity

57 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Moderate effect16 studies

Studies that measured anti-cancer activity

and 6 more in the citations list

Safety/Tolerability

6 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Small effect7 studies

Studies that measured safety/tolerability

Seizure Activity

3 preclinical studies support this finding. Primarily preclinical evidence.

Improves (the measure goes down)Small effect5 studies

Studies that measured seizure activity

Mortality

3 human trials support this finding. Human clinical trial data available.

Improves (the measure goes down)Small effect5 studies

Studies that measured mortality

Hormone Levels

3 human trials support this finding. Human clinical trial data available.

Improves (the measure goes up)Small effect5 studies

Studies that measured hormone levels

Key findings

  • Disease Control (Breast)Breast CancerImproves (the measure goes up)
  • Testosterone SuppressionProstate CancerImproves (the measure goes down)
  • PSA SuppressionProstate CancerImproves (the measure goes down)

Studies cited

32 studies from PubMed

  1. Real-world effectiveness and safety of goserelin 10.8-mg depot in Chinese patients with localized or locally advanced prostate cancer.Cancer biology & medicine, 2024 · PMID 38318809
  2. Multicenter, prospective, single-arm clinical study to investigate the efficacy and safety of Zoladex (Goserelin acetate) 10.8 mg prior to surgery in Chinese premenopausal women with symptomatic uterine fibroids.Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology, 2024 · PMID 39624028
  3. Clinical efficacy and safety of trimonthly administration of goserelin acetate 10.8 mg in premenopausal Chinese females with symptomatic adenomyosis: a prospective cohort study.Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology, 2023 · PMID 36563705
  4. Erythema nodosum caused by goserelin acetate sustained-release: Case report and literature review.International journal of rheumatic diseases, 2023 · PMID 37114900
  5. Gonadotropin-releasing hormone agonists in prostate cancer: A comparative review of efficacy and safetyIndian J Cancer, 2022 · PMID 35343198
  6. Twenty-Year Benefit From Adjuvant Goserelin and Tamoxifen in Premenopausal Patients With Breast Cancer in a Controlled Randomized Clinical Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022 · PMID 35862873
  7. Phase 3, open-label, randomized study comparing 3-monthly with monthly goserelin in pre-menopausal women with estrogen receptor-positive advanced breast cancer.Breast cancer (Tokyo, Japan), 2016 · PMID 26350351
  8. Spontaneous reports of seizure in association with leuprolide (lupron depot), goserelin (zoladex implant), and naferelin (synarel nasal spray).Obstetrics and gynecology, 2013 · PMID 23635751
  9. Failure of ovarian ablation with goserelin in a pre-menopausal breast cancer patient resulting in pregnancy: a case report and review of the literature.Breast cancer research and treatment, 2011 · PMID 21541703
  10. Goserelin: a review of its use in the treatment of early breast cancer in premenopausal and perimenopausal women.Drugs, 2005 · PMID 16392882
  11. Adjuvant goserelin improves clinical disease-free survival and reduces disease-related mortality in patients with locally advanced or localized prostate cancer.BJU international, 2004 · PMID 14678365
  12. Similar frequency of testosterone surge after repeat injections of goserelin (Zoladex) 3.6 mg and 10.8 mg: results of a randomized open-label trial.Urology, 2004 · PMID 15596193
  13. Survival analyses from the ZEBRA study. goserelin (Zoladex) versus CMF in premenopausal women with node-positive breast cancer.European journal of cancer (Oxford, England : 1990), 2003 · PMID 12888366
  14. Acute goserelin administration inhibits gonadotropin and androgen secretion in post-menopausal women with ovarian hyperandrogenism.Journal of endocrinological investigation, 2003 · PMID 12809169
  15. [Clinical uses of goserelin in gynecologic diseases and its safety].Zhonghua fu chan ke za zhi, 1998 · PMID 10682460
  16. Comparison of goserelin and leuprolide in combined androgen blockade therapy.Urology, 1998 · PMID 9671875
  17. Goserelin. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in benign gynaecological disorders.Drugs, 1996 · PMID 8808170
  18. Goserelin. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic efficacy in prostate cancerDrugs Aging, 1995 · PMID 7613021
  19. A phase II trial of goserelin (Zoladex) in relapsed epithelial ovarian cancer.British journal of cancer, 1992 · PMID 1314071
  20. Catamenial epilepsy and goserelin.Lancet (London, England), 1992 · PMID 1346217
  21. Zoladex (goserelin) in the treatment of benign gynaecological disorders: an overview of safety and efficacy.British journal of obstetrics and gynaecology, 1992 · PMID 1532509
  22. Goserelin. A review of its pharmacodynamic and pharmacokinetic properties, and clinical use in sex hormone-related conditionsDrugs, 1991 · PMID 1709853
  23. Goserelin acetate implant: a depot luteinizing hormone-releasing hormone analog for advanced prostate cancer.DICP : the annals of pharmacotherapy, 1991 · PMID 1835221
  24. Catamenial epilepsy and goserelin.Lancet (London, England), 1991 · PMID 1683955
  25. Goserelin (Zoladex) in premenopausal advanced breast cancer: duration of response and survival.British journal of cancer, 1990 · PMID 2147110
  26. Zoladex plus flutamide vs. orchidectomy for advanced prostatic cancer. Danish Prostatic Cancer Group (DAPROCA).European urology, 1990 · PMID 2151275
  27. Phase III studies to compare goserelin (Zoladex) with orchiectomy and with diethylstilbestrol in treatment of prostatic carcinoma.Urology, 1989 · PMID 2523611
  28. Goserelin, a depot gonadotrophin-releasing hormone agonist in the treatment of premenopausal patients with metastatic breast cancer. German Zoladex Trial Group.Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 1989 · PMID 2526863
  29. Zoladex in advanced breast cancer.Hormone research, 1989 · PMID 2533151
  30. Zoladex: therapeutic effects in postmenopausal breast cancer.Hormone research, 1989 · PMID 2533153
  31. Zoladex (ICI 118,630): clinical trial of new luteinizing hormone-releasing hormone analog in metastatic prostatic carcinoma.Urology, 1987 · PMID 2949417
  32. Zoladex: a sustained-release, monthly luteinizing hormone-releasing hormone analogue for the treatment of advanced prostate cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 1987 · PMID 2953870