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Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

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Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

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Androgens

240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.

240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.

240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.

Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9

Degarelix

Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9

Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10

Clinical Development Support

The rationale of the study was to evaluate different degarelix dosing regimens for a three-month interval that was to produce and maintain castration in prostate cancer patients through immediate and prolonged testosterone suppression, and to provide confirmatory evidence of the safety of degarelix.

A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer

An Open-label Multi-center, Randomized Parallel Group Comparison of Efficacy and Safety of Degarelix Three-Month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer

Figure in the table give the number of participants with all testosterone values \<=0.5 ng/mL from Day 28 to the end of the study.

Figures in the table give the number of participants with all testosterone values \<=0.5 ng/mL after the dose at Day 28 to end of study. Thus, the testosterone response after the initial dose is not included in this outcome measure.

Figures in the table give number of participants with testosterone \<=0.5 ng/mL 28 days after the initial dose of trial medication.

The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \>3x ULN and ALT increases \>3x ULN with concurrently increased bilirubin \>1.5 ULN.

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.

Degarelix 240@40/240@40 (1,3,6,9)

Degarelix 240@40/240@60 (1,3,6,9)

Degarelix 240@40/240@60 (1,4,7,10)

Total

ITT population. ITT refers to the intent-to-treat population, which includes participants who were both randomized and treated.

Age, Categorical

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

ITT population. Curative intent refers to radical prostatectomy or radiotherapy.

Curative Intent

7-10

ITT population. 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. The Gleason scores were missing for two participants.

Gleason Score

Localized

Locally advanced

Metastatic

Not classifiable

ITT population. Stage of prostate cancer was classified according to the Tumour, Nodule and Metastatic classification that is a cancer staging system that describes the extent of cancer. T describes the size of the tumor and whether it has invaded nearby tissue, N describes regional lymph nodes that are involved, and M describes distant metastasis.

Stage of Prostate Cancer

Time Since Prostate Cancer Diagnosis

Body Weight

Body Mass Index

Serum Testosterone Levels

Serum Prostate Specific Antigen Levels

Number of Participants With Testosterone Level <=0.5 ng/mL From Day 28 Until the End of the Study

Number of Participants With Testosterone Level <=0.5 ng/mL After the Dose at Day 28 Until the End of the Study

Number of Participants With Testosterone <=0.5 ng/mL at Day 28

Abnormal alanine aminotransferase (ALAT)

Abnormal aspartate aminitransferase

Abnormal bilirubin

ALAT >3x upper limit of normal (ULN)

ALAT >3x ULN, bilirubin 1.5x ULN

Liver Function Tests

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 Change in Vital Signs and Body Weight as Compared to Baseline

Overall Study

Pharmaceutical Solutions

Initial dose of 200 milligrams (40 milligrams per milliliter) of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams (20 milligrams per milliliter) of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.

Initial dose of 200 milligrams (40 milligrams per milliliter) of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams (20 milligrams per milliliter) of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.

Drug supplied as a powder to be dissolved in the solvent for solution for injection. Maintenance dose given in twelve 28-day cycles.

The purpose of the study was to contribute, along with other such dose-finding studies, to the identification of the most effective treatment regimen for a one month depot injection of degarelix in the treatment of prostate cancer by a rapid and sustained suppression of testosterone.

A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer

An Open-label, Randomized, Multi-center, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer Dosed for Thirteen 28-day Cycles

Number of participants with all testosterone values \<=0.5 nanogram/milliliter from Day 28 to Day 364

Number of participants who maintained a testosterone level of \<=0.5 nanogram/milliliter from Day 28 to Day 364.

Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing.

Median number of days after the first dose of Degarelix when the Prostate-Specific Antigen levels fell to 50 percent and 90 percent of the baseline value.

Median days to prostate-specific antigen increase of \>= 50 percent and \>= 5 nanograms/milliliter compared to nadir on two consecutive visits at least 2 weeks apart.

Di-hydrotestosterone levels at baseline and days 1, 3, 7, 14

Prostate-specific antigen levels at baseline and days 3, 14, 28, 84, and 364.

Luteinizing hormone levels at baseline, and days 1, 3, 7, and 14.

Testosterone levels at baseline and days 1, 3, 7, 14 and 364

Participants whose alanine aminotransferase values were at levels above the normal range.

Participants with aspartate aminotransferase values that were above the normal range.

Participants with abnormal total bilirubin values

Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of participants in each group with normal baseline values and markedly abnormal end-of-study values.

Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.

Degarelix 60mg

Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.

Degarelix 80mg

A curative intent of Yes refers to participants who have been castrated via radical prostatectomy or radiotherapy.

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.

Participant Counts by Gleason Score

Prostate cancer stage was classified 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.

The Number of Participants at Each Stage of Prostate Cancer

Body mass index is a measure of body fat based on height and weight.

The number of days passed since a diagnosis of prostate cancer was made for each participant.

Days Since Diagnosis of Prostate Cancer

Prostate-specific antigen (PSA) is a protein produced by the cells of the prostate gland. The PSA test measures the level of PSA in the blood. High PSA levels have a postive corrolation to prostate cancer.

Serum Prostate-Specific Antigen

Testosterone is a steroid hormone from the androgen group, and the principal male sex hormone. This test measures the amount of testosterone in the blood. Androgen deprivation is used to manage prostate cancer.

Serum Testosterone level

Weight

ITT population of patients who completed the study and had testosterone \<=0.5 nanogram per milliliter at Day 28.

Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364

Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.

ITT population of participants who completed the study and had a testosterone level of \<=0.5 nanogram per milliliter at Day 28.

Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28

50 percent reduction (n=59, 59)

90 percent reduction (n=45, 48)

Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen

ITT population. 5 patients in the 60 mg group and 4 patients in the 80 mg group had PSA progression.

Days to Prostate-Specific Antigen Progression

Baseline (n=63, 64)

Day 1 (n=62, 62)

Day 3 (n=58, 63)

Day 7 (n=58, 63)

Day 14 (n=61, 61)

Median Di-Hydrotestosterone Levels At Various Study Timepoints

Day 3 (n=60, 64)

Day 14 (n=61, 63)

Day 28 (n=61, 63)

Day 84 (n=57, 54)

Day 364 (n=42, 43)

Median Prostate-Specific Antigen Values at Various Study Timepoints

Day 1 (n=58, 61)

Day 3 (n=59, 60)

Day 7 (n=60, 61)

Day 14 (n=61, 62)

Median Luteinizing Hormone Levels at Various Study Timeframes

Day 1 (n=61, 63)

Day 3 (n=60, 63)

Day 7 (n=60, 64)

Median Testosterone Levels at Various Days During the Study

> upper limit and 3 times upper limit

Total abnormal (> upper limit)

Total normal (<=upper limit)

Number of Participants With Abnormal Alanine Aminotransferase Values

> 3 times upper limit - 5 times upper limit

> upper limit - 3 times upper limit

Total Abnormal (> upper limit)

Total Normal (<= upper limit)

Number of Participants With Abnormal Aspartate Aminotransferase Values

>2 times upper limit

>1.5 times upper limit

> upper limit - 1.5 times upper limit

Number of Participants With Abnormal Total Bilirubin Values

Diastolic blood pressure <= 50 and decrease >= 15

Diastolic blood pressure >= 105 and increase >= 15

Pulse <=50 and decrease of >=15

Pulse >=120 and increase of >=15

Weight decrease of >=7 percent

Weight increase of >= 7 percent

ITT population. Diastolic blood pressure n=63,63 Pulse n=63,60 Systolic blood pressure n=63,64 Weight n=55,61

Participants With Markedly Abnormal Changes in Vital Signs or Body Weight

In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.

In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.

In the main study (FE200486 CS02; NCT00819247) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.

Given as a subcutaneous injection once every 4 weeks.

To investigate the long-term safety and tolerability of repeated doses of degarelix to prostate cancer patients

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention (FDA regulated intervention is therefore ticked "YES").

The data include participants from both the main study (FE200486 CS02; NCT00819247) and the extension study FE200486 CS02A.

Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients

An Open-Label, Multi-Centre, Extension Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients.

Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.

In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.

Degarelix 80/80 + 40

In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.

Degarelix 40/40 + 40

In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.

Degarelix 80 + 20

Black

White

Indian

Afro-Carribean

Race/Ethnicity, Customized

Unknown

Gleason score

Number of Participants With Curative Intent

Number of Participants at Each Stage of Prostate Cancer

Body mass index

Serum testosterone levels

Abnormal aspartate aminotransferase

ALAT >3x ULN

ALAT >3x ULN, bilirubin >1.5x ULN

The data include patients from both the main study (FE200486 CS02) and the extension study FE200486 CS02A.

These data include patients from the main study (FE200486 CS02) and the extension study (FE200486 CS02A).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer	NCT00116753	Prostate Cancer	Degarelix Degarelix Degarelix	18 Years -	Ferring Pharmaceuticals
A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer	NCT00116779	Prostate Cancer	Degarelix	18 Years -	Ferring Pharmaceuticals
Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients	NCT00245466	Prostate Cancer	Degarelix Degarelix Degarelix	18 Years -	Ferring Pharmaceuticals
Cabozantinib and Androgen Ablation in Patients With Androgen-Dependent Metastatic Prostate Cancer	NCT01630590	Prostate Cancer	Cabozantinib Androgen Ablati...	-	M.D. Anderson Cancer Center
Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients	NCT00117312	Prostate Cancer	Degarelix Degarelix Degarelix Degarelix	18 Years -	Ferring Pharmaceuticals
Cabozantinib and Androgen Ablation in Patients With Androgen-Dependent Metastatic Prostate Cancer	NCT01630590	Prostate Cancer	Cabozantinib Androgen Ablati...	-	M.D. Anderson Cancer Center
A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer	NCT00116779	Prostate Cancer	Degarelix	18 Years -	Ferring Pharmaceuticals
Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486	NCT00117949	Prostate Cancer	Degarelix Degarelix Degarelix Degarelix	18 Years -	Ferring Pharmaceuticals
An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer	NCT00215683	Prostate Cancer	Degarelix	18 Years -	Ferring Pharmaceuticals
Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer	NCT00268892	Prostate Cancer	Degarelix Degarelix Degarelix	18 Years -	Ferring Pharmaceuticals
Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486	NCT00117949	Prostate Cancer	Degarelix Degarelix Degarelix Degarelix	18 Years -	Ferring Pharmaceuticals

Spots Global Cancer Trial Database for androgen ablation therapy