Degarelix and its therapeutic potential in the treatment of prostate cancer

Figures & data

Table 1 Published phase II and III trials on degarelix and prostate cancer: Efficacy

Author	Patients	Study design	Results
Gittelman^Citation20	N = 127	Phase II Efficacy and safety of degarelix with a starting dose of 200 mg followed by monthly maintenance doses of 60 mg or 80 mg for one year.	Testosterone suppression: 88% after one month, 93% and 98% (60 mg and 80 mg) after one year. PSA response: Median reduction 96% after one year
van Poppel^Citation21	N = 187	Phase II Efficacy and safety of degarelix with a 200 mg or 240 mg starting dose followed by monthly maintenance doses of 80 mg, 120 mg, or 160 mg for one year.	Testosterone suppression: 86% (200 mg) vs 95% (240 mg) after one month, 92% (80 mg), 96% (120 mg), 100% (160 mg) after one year. PSA response: Median reduction 97%–98% after one year
Klotz^Citation14	N = 610	Phase III Efficacy and safety of degarelix with a starting dose of 240 mg followed by monthly maintenance dose of 80 mg or 160 mg vs leuprolide 7.5 mg monthly.	Testosterone suppression: 97.2%, 98.3% in patients treated with degarelix (240/80 mg, 240/160 mg) and 96.4% in patients treated with leuprolide after one year. PSA response: PSA decline from baseline was significant faster in the degarelix groups than with leuprolide, PSA values not given in publication.

Abbreviation: PSA, prostate-specific antigen.

Table 2 Published phase II and III trials on degarelix and prostate cancer: adverse events

Adverse event	Gittelman^Citation20 (Phase II) degarelix 200/80 vs 200/60	van Poppel^Citation21 (Phase II) degarelix 200/80 vs 200/120 vs 200/160 vs 240/80 vs 240/120 vs 240/160	Klotz^Citation14 (Phase III) 240/80 vs 240/160 vs leuprolide 7.5
Any adverse event (%)	87/81	57/66/75/63/73/67	79/83/78
Hot flash (%)	38/48	47/25/31/37/27/33	26/26/21
Fatigue (%)	16/23	7/3/6/10/3/7	3/6/6
Injection site pain (%)	6/8	3/9/0/13/9/7	Not given
Injection site reaction (%)	Not given	Not given	35/44/1
Weight increase (%)	6/6	0/9/13/13/9/7	9/11/12
Back pain (%)	3/9	7/9/6/3/6/3	6/6/8
Nasopharyngitis (%)	11/11	Not given	Not given
Dizziness (%)	11/9	Not given	Not given
Arthralgia (%)	6/6	Not given	5/3/9
Constipation (%)	6/6	Not given	3/5/5
Hypertension (%)	6/6	Not given	6/7/4
Urinary tract infection (%)	Not given	7/6/6/7/6/3	5/1/9
ALT increase (%)	Not given	10/3/9/0/3/3	10/8/5
Cough (%)	Not given	7/3/6/0/3/7	Not given
Diarrhea (%)	Not given	3/9/6/0/3/7	Not given
Chills (%)	Not given	Not given	3/5/0

Abbreviation: ALT, alanine aminotransferase.

GittelmanMPommervillePJPerssonBEJensenJKOlesenTKDegarelix Study GroupA 1-year, open label, randomized phase II dose finding study of degarelix for the treatment of prostate cancer in North AmericaJ Urol200818051986199218801505

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Van PoppelHTombalBde la RosetteJJDegarelix: a novel gonadotropin-releasing hormone (GnRH) receptor blocker–results from a 1-yr, multicentre, randomised, phase 2 dosage-finding study in the treatment of prostate cancerEur Urol200854480581318538469

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KlotzLBoccon-GibodLShoreNDThe efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancerBJU Int2008102111531153819035858

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