Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer

Ferring

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Degarelix; Drug: Goserelin; Drug: Bicalutamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00833248

FE200486 CS30

2008-005232-33 (EudraCT Number)

Details and patient eligibility

About

The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.

Enrollment: 246 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has given written informed consent before any trial-related activity is performed.
• Has a confirmed prostate cancer in which this type of treatment is needed.

Exclusion criteria

• Previous treatment for prostate cancer
• Previous trans-urethral resection of the prostate
• Patients who are lymph node positive or have other metastatic disease
• Use of urethral catheter
• Current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
• History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
• Hypersensitivity towards any component of the investigational product
• Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
• Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
• Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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246 participants in 2 patient groups

Degarelix 240 mg/80 mg

Experimental group

Description:

The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.

Treatment:

Drug: Degarelix

Goserelin (3.6 mg) + bicalutamide (50 mg)

Active Comparator group

Description:

On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.

Treatment:

Drug: Bicalutamide

Drug: Goserelin