Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Goserelin

The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.

Degarelix

Clinical Development Support

Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.

A Long Term Safety Study of Degarelix in Patients With Prostate Cancer

A Phase IIIb, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients With Prostate Cancer

PSA levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)

Testosterone levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)

The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.

This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.

Ferring Pharmaceuticals

Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.

Age Continuous

Sex: Female, Male

France

Spain

Belgium

Turkey

Italy

Sweden

Region of Enrollment

Body Mass Index (BMI)

Gleason Score 2-4

Gleason Score 5-6

Gleason Score 7-10

The Gleason score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive.

Gleason Score

Localized

Locally Advanced

Metastatic

Not Classifiable

Prostate cancer stage was classified according to the Tumor, Nodes, and Metastatic (TNM) scale to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor. Some participants did not have their prostate cancer classified for the complete TNM scale (7 participants).

Stage of Prostate Cancer

B-Haematocrit (Ratio) <=0.37

B-Haemoglobin (g/L) <=115

B-White blood cell count (10^9/L) <=2.8

B-White blood cell count (10^9/L) >=16.0

B-Red blood cell count (10^12/L) <=3.5

B-Platelet count (10^9/L) <=75

S-Aspartate aminotransferase (IU/L) >3xULN

S-Potassium (mmol/L) >=5.8

S-Urea nitrogen (mmol/L) >=10.7

Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables

Diastolic blood pressure <=50 and decrease >=15

Diastolic blood pressure >=105 and increase >=15

Systolic blood pressure <=90 and decrease >=20

Systolic blood pressure >=180 and increase >=20

Heart rate <=50 and decrease >=15

Heart rate >=120 and increase >=15

Body weight decrease of >=7 percent

Body weight increase of >=7 percent

Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight

Baseline (0 weeks)

Week 24

Week 36

Week 48

Week 72

The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)

Serum Levels of Prostate Specific Antigen (PSA)Over Time

Baseline (Week 0)

The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)

Serum Levels of Testosterone Over Time

Overall Study

Spots Global Cancer Trial Database for general health state