title: Prospective evaluation of testosterone fluctuations during a transition of therapy from degarelix to leuprolide in patients on androgen deprivation therapy.
abstract: OBJECTIVE
  To evaluate for a possible testosterone surge during transition of therapy from degarelix to leuprolide.
  
  
  METHODS
  We conducted an investigator-initiated, prospective, single-arm, open-label trial for evaluation of a potential testosterone surge during a transition of therapy from degarelix to leuprolide. Study patients were administered 3 monthly depot injections of degarelix, followed by one 3-month depot injection of leuprolide. A rise in serum testosterone was considered clinically relevant in previously castrate patients whose testosterone rose above 50 ng/dL.
  
  
  RESULTS
  Forty-five patients aged 59-86 years were included in the final analysis after completing the entire 6-month study. Nineteen percent of patients had received prior androgen deprivation therapy, and 10% had metastatic disease. Mean serum testosterone was reduced from a baseline of 374.6 ± 155.7 ng/dL to 16.5 ± 8.1 ng/dL, and prostate-specific antigen reduced from 23.8 ± 55.8 ng/mL to 1.6 ± 3.7 ng/mL after 3 months of treatment with degarelix. On transition from degarelix to leuprolide (day 90), there was a rise in testosterone from the nadir of 16.5 ng/dL to a peak of 25.8 ng/dL (P = .0005), occurring at day 93. Four patients (8.9%) experienced a testosterone surge with a mean peak serum testosterone of 80.7 ng/dL; all 4 returned to castrate levels within 7 days, and all remained asymptomatic throughout the testosterone fluctuation.
  
  
  CONCLUSIONS
  Fluctuations in serum testosterone after this transition of therapy were mild and short-lived with only 8.9% of men experiencing testosterone elevations to noncastrate levels.
authors.affiliation: Urology of Virginia, Department of Urology, Eastern Virginia Medical School, Norfolk, VA.
authors.forename: Jack M
authors.initials: JM
authors.lastname: Zuckerman
authors.affiliation: Urology of Virginia, Department of Urology, Eastern Virginia Medical School, Norfolk, VA.
authors.forename: Gregg
authors.initials: G
authors.lastname: Eure
authors.affiliation: Urology of Virginia, Department of Urology, Eastern Virginia Medical School, Norfolk, VA.
authors.forename: John
authors.initials: J
authors.lastname: Malcolm
authors.affiliation: Urology of Virginia, Department of Urology, Eastern Virginia Medical School, Norfolk, VA.
authors.forename: Lilian
authors.initials: L
authors.lastname: Currie
authors.affiliation: Urology of Virginia, Department of Urology, Eastern Virginia Medical School, Norfolk, VA. Electronic address: givenrw@aol.com.
authors.forename: Robert
authors.initials: R
authors.lastname: Given
mesh_terms: D000230:Adenocarcinoma / Q000097:blood / Q000188:drug therapy*; D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000627:therapeutic use; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D007987:Gonadotropin-Releasing Hormone / Q000037:antagonists & inhibitors; D006801:Humans; D016729:Leuprolide / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000627:therapeutic use*; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy*; D013739:Testosterone / Q000097:blood*
chemical_list: D000726:Androgen Antagonists; D018931:Antineoplastic Agents, Hormonal; D009842:Oligopeptides; C431566:acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; D007987:Gonadotropin-Releasing Hormone; D013739:Testosterone; D017430:Prostate-Specific Antigen; D016729:Leuprolide