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LHRH Antagonist
Degarelix for Prostate Cancer
Phase 2
Waitlist Available
Led By Kim N Chi, MD
Research Sponsored by British Columbia Cancer Agency
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weekly
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
Men with castrate resistant prostate cancer who are switched from a luteinizing hormone-releasing hormone (LHRH) antagonists from a LHRH agonist will experience a fall in prostate-specific antigen (PSA).
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weekly
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weekly
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
50% fall in PSA
Secondary study objectives
Follicle stimulating hormone (FSH)
Luteinizing hormone (LH)
Testosterone (TT)
+4 moreSide effects data
From 2009 Phase 2 & 3 trial • 57 Patients • NCT0011728656%
Hot flush
26%
Weight increased
22%
Injection site pain
22%
Nasopharyngitis
22%
Back pain
22%
Upper respiratory tract infection
19%
Fatigue
19%
Constipation
19%
Injection site erythema
19%
Chills
19%
Arthralgia
19%
Dizziness
19%
Nocturia
19%
Rash
19%
Injection site nodule
15%
Cataract
15%
Injection site induration
15%
Arthritis
15%
Dysuria
15%
Hypertension
15%
Hypotension
11%
Colonic polyp
11%
Musculoskeletal pain
11%
Insomnia
11%
Micturition urgency
11%
Pollakiuria
11%
Nasal congestion
7%
Injection site warmth
7%
Myocardial ischaemia
7%
Nausea
7%
Anaemia
7%
Oedema peripheral
7%
Injection site mass
7%
Pyrexia
7%
Asthenia
7%
Injection site reaction
7%
Weight decreased
7%
Cardiac murmur
7%
Decreased appetite
7%
Hyperlipidaemia
7%
Bursitis
7%
Pain in extremity
7%
Rotator cuff syndrome
7%
Headache
7%
Haematuria
7%
Dyspnoea
7%
Actinic keratosis
7%
Urethral stenosis
7%
Gynaecomastia
7%
Erectile dysfunction
7%
Chest discomfort
4%
Urinary tract infection
4%
Inguinal hernia, obstructive
4%
General physcial health deterioration
4%
Lumbar spinal stenosis
4%
Osteoarthritis
4%
Prostate cancer
4%
Aortic aneurysm
4%
Chronic obstructive pulmonary disease
4%
Hyperhidrosis
4%
Abdominal pain
4%
Injection site haematoma
4%
Pain
4%
Bronchitis
4%
Tooth abscess
4%
Contusion
4%
Procedural pain
4%
Prostatic specific antigen increased
4%
Gamma-glutamyltransferase increased
4%
Diabetes mellitus
4%
Benign prostatic hyperplasia
4%
Cough
4%
Coronary artery disease
4%
Vertigo
4%
Osteonecrosis
4%
Urinary retention
4%
Atrioventricular block first degree
4%
Myocardial infarction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Degarelix (80 mg to 160 mg)
Degarelix (60 mg to 160 mg)
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: DegarelixExperimental Treatment1 Intervention
Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Degarelix
FDA approved
Find a Location
Who is running the clinical trial?
Ferring PharmaceuticalsIndustry Sponsor
322 Previous Clinical Trials
1,243,030 Total Patients Enrolled
52 Trials studying Prostate Cancer
17,128 Patients Enrolled for Prostate Cancer
British Columbia Cancer AgencyLead Sponsor
175 Previous Clinical Trials
94,224 Total Patients Enrolled
22 Trials studying Prostate Cancer
4,208 Patients Enrolled for Prostate Cancer
Kim N Chi, MDPrincipal InvestigatorBritish Columbia Cancer Agency, Univeristy of British Columbia
5 Previous Clinical Trials
535 Total Patients Enrolled
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