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The Effect of Basel...
The Effect of Baseline Testosterone on the Efficacy of Degarelix and Leuprolide: Further Insights From A 12-Month, Comparative, Phase III Study in Prostate Cancer Patients
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- Damber, Jan-Erik, 1949 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för urologi,Institute of Clinical Sciences, Department of Urology
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Tammela, T. L. J. (author)
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Iversen, P. (author)
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- Abrahamsson, Per-Anders (author)
- Lund University,Lunds universitet,Urologi, Malmö (Abrahamsson),Forskargrupper vid Lunds universitet,Urological research, Malmö,Lund University Research Groups
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Boccon-Gibod, L. (author)
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Olesen, T. K. (author)
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van der Meulen, E. (author)
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Persson, B. E. (author)
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(creator_code:org_t)
- Elsevier BV, 2012
- 2012
- English.
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In: Urology. - : Elsevier BV. - 0090-4295 .- 1527-9995. ; 80:1, s. 174-180
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Abstract
Subject headings
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- OBJECTIVE To investigate the effects of baseline testosterone on testosterone control and prostate-specific antigen (PSA) suppression using data from a phase III trial (CS21) comparing degarelix and leuprolide in prostate cancer. METHODS In CS21, patients with histologically confirmed prostate cancer (all stages) were randomized to degarelix 240 mg for 1 month followed by monthly maintenance doses of 80 or 160 mg, or leuprolide 7.5 mg/month. Patients receiving leuprolide could receive antiandrogens for flare protection. Treatment effects on testosterone and PSA reduction, testosterone surge, and microsurges were investigated in 3 baseline testosterone subgroups: <3.5, 3.5-5.0, and >5.0 ng/mL. Data are presented for the groups receiving degarelix 240/80 mg (the approved dose) and leuprolide 7.5 mg. RESULTS Higher baseline testosterone delayed castration with both treatments. However, castrate testosterone levels and PSA suppression occurred more rapidly with degarelix irrespective of baseline testosterone. With leuprolide, the magnitude of testosterone surge and microsurges increased with increasing baseline testosterone. There was no overall correlation between baseline testosterone and initial PSA decrease in either treatment group, although PSA suppression tended to be slowest with leuprolide and fastest with degarelix in the high baseline testosterone subgroup. CONCLUSION Patients with high baseline testosterone may have greater risk of tumor stimulation (clinical flare) and mini-flares during gonadotrophin-releasing hormone agonist treatment and so the need for flare protection with antiandrogens in these patients is obvious, especially in metastatic disease. Although higher baseline testosterone delays castration, castrate testosterone and PSA suppression occur more rapidly with degarelix, irrespective of baseline testosterone, without the need for flare protection. UROLOGY 80: 174-181, 2012. (c) 2012 Elsevier Inc.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Urology and Nephrology (hsv//eng)
Keyword
- gonadotropin-releasing-hormone
- androgen deprivation therapy
- open-label
- serum testosterone
- multicenter
- men
- carcinoma
- trial
- castration
- abarelix
Publication and Content Type
- ref (subject category)
- art (subject category)
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