FDA approved Zoladex (goserelin) for Locally Confined and Advanced Prostate CancerFDA approved Zoladex for prostate cancer treatment.

FDA From the archive Source published January 11, 1996 Summary added May 12, 2026 DOI ↗ Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

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Key Takeaway

Consider Zoladex 10.8 mg every 12 weeks for androgen deprivation in prostate cancer, with similar efficacy to the 3.6 mg monthly dose.

The FDA has approved Zoladex (goserelin), a gonadotropin-releasing hormone (GnRH) agonist, for two indications in prostate cancer. For locally confined stage T2b-T4 (stage B2-C) carcinoma of the prostate, Zoladex is indicated in combination with flutamide, starting 8 weeks prior to radiation therapy and continuing during radiation. For advanced prostate cancer, Zoladex is indicated as palliative treatment. The approval is based on studies showing similar long-term endocrine responses, objective responses, and survival compared to orchiectomy for the 3.6 mg dose, and pharmacodynamic equivalence for the 10.8 mg dose. The 10.8 mg implant is administered subcutaneously every 12 weeks, offering a convenient dosing schedule for clinicians.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

ZOLADEX is a Gonadotropin Releasing Hormone (GnRH) agonist. It suppresses serum testosterone levels.

Indication & Patient Population

ZOLADEX is indicated for: Use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate; Use as palliative treatment of advanced carcinoma of the prostate.

Dosing & Administration

ZOLADEX 10.8 mg should be administered subcutaneously every 12 weeks into the anterior abdominal wall below the navel line. For Stage B2-C prostatic carcinoma, treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy. A treatment regimen using one ZOLADEX 3.6 mg depot, followed in 28 days by one ZOLADEX 10.8 mg depot, should be administered. For advanced prostate cancer, ZOLADEX is intended for long-term administration unless clinically inappropriate. No dosage adjustment is necessary for patients with renal or hepatic impairment. ZOLADEX 10.8 mg implant is not indicated in women.

Key Clinical Trial Data

In controlled studies of patients with advanced prostatic cancer comparing ZOLADEX 3.6 mg to orchiectomy, the long-term endocrine responses and objective responses were similar between the two treatment arms. Duration of survival was similar between the two treatment arms in a major comparative trial. In controlled studies, ZOLADEX 10.8 mg implant produced pharmacodynamically similar effect in terms of suppression of serum testosterone to that achieved with ZOLADEX 3.6 mg implant. Clinical outcome similar to that produced with the use of the ZOLADEX 3.6 mg implant administered every 28 days is predicted with the ZOLADEX 10.8 mg implant administered every 12 weeks.

Warnings & Contraindications

Not reported in label.

Place in Therapy

ZOLADEX is a GnRH agonist used for androgen deprivation therapy in prostate cancer. It is indicated for both locally confined disease (in combination with flutamide and radiation) and advanced disease as palliative treatment. The 10.8 mg implant provides a 12-week dosing interval.

The FDA has approved a new drug called Zoladex (goserelin) to treat prostate cancer. It is used in two ways. For men with early stage prostate cancer (stage T2b to T4), Zoladex is given along with another drug called flutamide. Treatment starts 8 weeks before radiation therapy and continues during radiation. For men with advanced prostate cancer that has spread, Zoladex is used as palliative treatment to help relieve symptoms and slow the cancer's growth.

Zoladex works by lowering certain hormones that can fuel prostate cancer. It is given as a small implant under the skin. There are two doses: a 3.6 mg implant given every month and a 10.8 mg implant given every 12 weeks. The longer acting dose offers a more convenient schedule for patients and doctors.

The approval was based on studies that showed Zoladex works as well as surgical removal of the testicles (orchiectomy) in controlling the cancer. The 10.8 mg dose was shown to be pharmacodynamically equivalent to the 3.6 mg dose.

This approval gives men with prostate cancer another treatment option. However, it is important to remember that every patient is different. If you or a loved one has prostate cancer, talk to your doctor about whether Zoladex might be right for you. Your doctor can explain the benefits and risks based on your specific situation.

What this means for you:

Zoladex is a new hormone therapy for prostate cancer, but always discuss treatment options with your doctor.

Study Details

Study typeFda approval

PublishedJan 1996

View Original Abstract ↓

1 INDICATIONS AND USAGE ZOLADEX is a Gonadotropin Releasing Hormone (GnRH) agonist indicated for: Use in combination with flutamide for the management of locally confined carcinoma of the prostate ( 1.1 ) Use as palliative treatment of advanced carcinoma of the prostate ( 1.2 ) 1.1 Stage B2-C Prostatic Carcinoma ZOLADEX is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy [see Dosage and Administration ( 2.1 ) and Clinical Studies ( 14.1 )]. 1.2 Prostatic Carcinoma ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate [see Dosage and Administration ( 2.2 ) and Clinical Studies ( 14.2 )]. In controlled studies of patients with advanced prostatic cancer comparing ZOLADEX 3.6 mg to orchiectomy, the long-term endocrine responses and objective responses were similar between the two treatment arms. Additionally, duration of survival was similar between the two treatment arms in a major comparative trial. In controlled studies of patients with advanced prostatic cancer, ZOLADEX 10.8 mg implant produced pharmacodynamically similar effect in terms of suppression of serum testosterone to that achieved with ZOLADEX 3.6 mg implant. Clinical outcome similar to that produced with the use of the ZOLADEX 3.6 mg implant administered every 28 days is predicted with the ZOLADEX 10.8 mg implant administered every 12 weeks. The automatic safety feature of the syringe aids in the prevention of needlestick injury.

FDA approved Zoladex (goserelin) for Locally Confined and Advanced Prostate CancerFDA approved Zoladex for prostate cancer treatment.

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