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Goserelin plus Bicalutamide
Goserelin suppresses testosterone production via GnRH receptor agonism, while bicalutamide blocks androgen receptor signaling, providing dual hormonal suppression for androgen-dependent cancers.
Goserelin suppresses testosterone production via GnRH receptor agonism, while bicalutamide blocks androgen receptor signaling, providing dual hormonal suppression for androgen-dependent cancers. Used for Metastatic prostate cancer, Locally advanced prostate cancer, High-risk localized prostate cancer (neoadjuvant/adjuvant to radiotherapy).
At a glance
| Generic name | Goserelin plus Bicalutamide |
|---|---|
| Sponsor | Speciality European Pharma Limited |
| Drug class | Androgen deprivation therapy (combination: GnRH agonist + androgen receptor antagonist) |
| Target | GnRH receptor (goserelin); androgen receptor (bicalutamide) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Goserelin is a GnRH agonist that initially stimulates then desensitizes the pituitary, leading to sustained suppression of luteinizing hormone and follicle-stimulating hormone, thereby reducing testosterone production. Bicalutamide is a non-steroidal androgen receptor antagonist that blocks residual androgens from binding to and activating androgen receptors on cancer cells. Together, this combination achieves maximal androgen deprivation therapy (ADT).
Approved indications
- Metastatic prostate cancer
- Locally advanced prostate cancer
- High-risk localized prostate cancer (neoadjuvant/adjuvant to radiotherapy)
Common side effects
- Hot flashes
- Erectile dysfunction
- Gynecomastia
- Fatigue
- Decreased libido
- Injection site reactions (goserelin)
- Diarrhea (bicalutamide)
- Hepatotoxicity
Key clinical trials
- Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer (PHASE1, PHASE2)
- Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer (PHASE3)
- Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer (PHASE3)
- Contributions to Hypertension With Androgen Deprivation Therapy (PHASE4)
- Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer (PHASE2)
- Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer (PHASE2)
- Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery (PHASE2, PHASE3)
- Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Goserelin plus Bicalutamide CI brief — competitive landscape report
- Goserelin plus Bicalutamide updates RSS · CI watch RSS
- Speciality European Pharma Limited portfolio CI