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Low Castrate T Levels

Low Castrate T Levels

ELIGARD® achieves low castrate testosterone levels across all doses. In the United States, the biochemical and regulatory definition of castration is a serum testosterone (T) level <50 ng/dL.

This value is based on the sensitivity of the assays available when androgen deprivation therapy (ADT) was first developed 50 years ago. With the advent of current improved assays, it is possible to detect much lower T levels (<3 ng/dL).

Data were pooled from four prospective, open-label, fixed dose clinical trials in patients with advanced prostate cancer. Patients with no prior ADT were treated with one of four formulations of subcutaneous leuprolide acetate (ELIGARD®):

  • 7.5 mg every 28 days for 24 weeks (1-month formulation; n=120)
  • 22.5 mg every 84 days for 24 weeks (3-month formulation; n=117)
  • 30 mg every 112 days for 32 weeks (4-month formulation; n=90)
  • 45 mg every 168 days for 48 weeks (6-month formulation; n=111)

In the pooled patient population, 99%, 97%, 91% and 80% of patients reached nadir testosterone levels of ≤20, ≤10, ≤5, and ≤3 ng/dL respectively, at week 24. [1]

The mean proportions of time T suppression was maintained below each target were 100% for T ≤50 ng/dL, 94% to 99% for T ≤20 ng/dL, and 66% to 85% for T ≤10 ng/dL. [2]

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Table: Proportion of time-tested testosterone levels maintained

All doses achieved and maintained mean serum testosterone to ≤20 ng/dL over 24 weeks with all four dose formulations, and reaching nadir T ≤3 ng/dL in 80% of patients. During the trial of the six-month formulation, testosterone suppression to ≤20 ng/dL was achieved in four weeks, and the mean serum testosterone concentration remained below this level for six months. [3]

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These results suggest that patients receiving subcutaneous leuprolide acetate can achieve consistent, stable and durable low T levels, with equivalent testosterone suppression to what is achieved by surgical castration. [3] [4]

Table: Mean serum testosterone concentration over first 24 weeks of all four studies
References
  1. ELIGARD® (leuprolide acetate) for injectable suspension, 7.5 mg, 22.5 mg, 30 mg, 45 mg prescribing information. Fort Collins, CO: Tolmar Therapeutics, Inc.; 2019
  2. Pieczonka C, et al., Rev Urol 2018
  3. National Comprehensive Cancer Network, NCCN Guidelines: Prostate Cancer, Version 4. 2019: National Comprehensive Cancer Network website. https://www.nccn.org/professionals/physician_gls/default.aspx#site. Accessed January 2019
  4. Shore N, et al., BJU Int. 2016

IMPORTANT SAFETY INFORMATION

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ELIGARD® is indicated for the palliative treatment of advanced prostate cancer.

ELIGARD is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components of ELIGARD. Anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have been reported in the literature. Transient increase in serum levels of testosterone during treatment may result in worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, bladder outlet obstruction, ureteral obstruction, or spinal cord compression.

Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs. Monitor blood glucose level and manage according to current clinical practice. Increased risk of myocardial infarction, sudden cardiac death and stroke has also been reported with use of GnRH analogs in men. Monitor for cardiovascular disease and manage according to current clinical practice. Androgen deprivation therapy may prolong the QT/QTc interval. Consider risks and benefits.

May cause fetal harm. ELIGARD may impair fertility in males of reproductive potential.

Convulsions have been observed in patients taking leuprolide acetate with or without a history of predisposing factors. Manage convulsions according to current clinical practice.

The most common injection site adverse events are transient burning and stinging, pain, bruising, and erythema. The most common systemic adverseevents include mild to severe hot flashes/sweats, malaise and fatigue, weakness, myalgia, dizziness, clamminess, testicular atrophy, and gynecomastia.

As with other GnRH agonists, other adverse reactions, including decreased bone density and rare cases of pituitary apoplexy have been reported.

See package insert for full prescribing and safety information.