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Phase 2 Study Assessing the Safety and Efficacy of a Monthly Dosing Regimen of Ozarelix Versus Goserelin Depot (Zoladex®) in Men With Prostate Cancer

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Phase 2 Study Assessing the Safety and Efficacy of a Monthly Dosing Regimen of Ozarelix Versus Goserelin Depot (Zoladex®) in Men With Prostate Cancer

Prospective study subjects will undergo screening procedures. Approximately 214 eligible
patients will enter the study. Patients will be randomized in a 1:1 ratio to one of two
treatment arms (Ozarelix or Goserelin). Eligible patients randomized to the ozarelix group
will receive two SC injections of ozarelix 65 mg in the abdomen on Day 1 (left lower
quadrant, LLQ and right lower quadrant, RLQ), followed by a SC injection of 65 mg of
Ozarelix (abdomen LLQ) on day 8 and will receive 2 additional SC injections of Ozarelix on
days 28 and 56 (alternating injection sites). Eligible patients randomized to Goserelin will
receive one 3.6 mg SC injection in the abdomen (LLQ or RLQ), followed by a 3.6 mg SC
injection on Days 28 and 56 (alternating injection sites). Ozarelix will be reconstituted
and administered as a 65 mg injection. Patients will receive two Ozarelix 65 mg subcutaneous
injections (SC) on Day 1, and one 65 mg SC injection on day 8, followed by one 65 mg
injection on days 28 and 56. The patients will receive one Goserelin 3.6 mg SC injection at
baseline, Day 28 and Day 56.

Inclusion Criteria:

- Patients, aged 18 years or older, with histologically proven prostate cancer of any
stages, for whom endocrine treatment is indicated.

- Screening testosterone > 1.5 ng/ml

- Life expectancy of at least 12 months

- ECOG score of ≤ 2

- Patient has reviewed and signed Informed consent form

- Patient understands and is willing to comply with the protocol

Exclusion Criteria:

- Any hormone therapy prior to study entrance

- Any patient at risk of urinary tract obstruction or spinal cord compression due to
potential testosterone surge

- History of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria
and/or angioedema

- History of hypersensitivity towards any components of the study drug

- History or presence of any other malignancy other than treated squamous cell /basal
cell carcinoma of the skin within the last five years

- ECG at screening showing QTc >450 ms, or family history of long QT syndrome

- Abnormal laboratory results which in the judgment of the investigator would affect
the patient's health or the outcome of the trial

• - Has a clinically significant medical condition (other than prostate cancer)
including but not limited to: renal, hematological, gastrointestinal, endocrine,
cardiac, neurological or psychiatric disease, alcohol or drug abuse or any other
condition that may affect the patient's health or the outcome of the trial as judged
by the investigator

- Taking Class IA or Class III antiarrhythmic medication

- Has an intellectual incapacity or language barrier precluding adequate understanding
or co-operation

- Has received investigational drug within the last 28 days before the Screening visit
or longer if considered to possibly influence the outcome of this trial

- Has previously participated in any Ozarelix trials

- Is part of an ongoing trial.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the percentage of patients with testosterone <=0.5ng/mL.

Outcome Time Frame:

From Day 28 through Day 84, in men receiving Ozarelix versus Goserelin

Safety Issue:


Principal Investigator

Pankaj Sharma, MD

Investigator Role:

Study Director

Investigator Affiliation:

Spectrum Pharmaceuticals, Inc


United States: Food and Drug Administration

Study ID:




Start Date:

November 2010

Completion Date:

September 2014

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



Urology San Antonio Research San Antonio, Texas  78229
Urology Clinics of North Texas Dallas, Texas  75231
The Urology Center of Colorado Denver, Colorado  80211