histrelin and Adenocarcinoma

This open label, multicenter study was done to evaluate the efficacy and safety of the gonadotropin hormone-releasing hormone agonist histrelin acetate administered as a 50 mg subdermal implant in men with advanced prostatic cancer.. The 3 cm x 3.5 mm histrelin implant was surgically inserted in the inner aspect of the upper nondominant arm of eligible patients under local anesthesia. Patients were evaluated weekly for the first 2 weeks after implant insertion and monthly thereafter. At week 52 the implant was removed and in most cases a new implant was inserted. Patient observation for safety and efficacy continued to week 60. Efficacy was determined by the proportion of patients who attained chemical castration (serum testosterone 50 ng/dl or less) at weeks 4 through 52.. Of the 134 patients with week 4 testosterone levels available 100% achieved chemical castration. Testosterone suppression was maintained throughout the 52 weeks after implantation in more than 99% of patients. Significant LH and PSA suppression was also observed. By week 16 PSA had decreased an average of 90% from a baseline of 83.6 ng/ml (p = 0.0001). By week 60, 79% of patients had a complete PSA response (p <0.0175). No testosterone or LH surge was observed with reimplantation. Additionally, the implant was safe and well tolerated.. The gonadotropin hormone-releasing hormone agonist histrelin acetate provided in a unique implant delivery device is effective for treating men with advanced prostate cancer, as demonstrated by the suppression of testosterone and LH to castrate levels at 4 weeks and the maintenance of these levels during 52 weeks. PSA, a secondary end point for effectiveness, was also suppressed significantly from baseline.

Topics: Adenocarcinoma; Administration, Cutaneous; Aged; Aged, 80 and over; Disease Progression; Drug Implants; Gonadotropin-Releasing Hormone; Humans; Male; Middle Aged; Prostatic Neoplasms; Safety

We present a case report of a patient with prostate cancer who failed to demonstrate consistent testosterone suppression to castration levels and incomplete suppression of serum prostate-specific antigen, although treated with gonadotropin releasing hormone agonists for 48 months. Serum dehydroepiandrosterone, dehydroepiandrosterone sulphate, as well as the androgen metabolite, androsterone glucuronide, were elevated compared to the other patients. The present data suggest that those prostate cancer patients who have even marginally elevated adrenal androgens may especially benefit from combined androgen blockade.

Topics: Adenocarcinoma; Aged; Androgen Antagonists; Androgens; Anilides; Buserelin; Diarrhea; Flutamide; Gastrectomy; Glaucoma; Gonadotropin-Releasing Hormone; Hernia, Hiatal; Humans; Luteinizing Hormone; Male; Nitriles; Peptic Ulcer; Prostate-Specific Antigen; Prostatic Neoplasms; Testosterone; Tosyl Compounds