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The study will have two treatment groups, evaluating two Degarelix doses. First dose is the initial dose followed by a maintenance dose given every three months. The initial dose given to suppress the testosterone level and the three month maintenance dose to maintain the suppressed testosterone level over one year of treatment.
An Open-Label, Multi-Centre, Randomized Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients with Prostrate Cancer Requiring Androgen Ablation Therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months. |
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| B | Experimental | Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix | Drug | Experimental Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364 | Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Levels of Testosterone Over Time | 1 year | |
| Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364 | Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 56 to Day 364. |
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Inclusion / Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Centers of Alabama | Homewood | Alabama | 35209 | United States | ||
| South Orange County Medical Research Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Degarelix 240/360 mg | Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months. |
| FG001 | Degarelix 240/480 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Degarelix | Drug | Experimental Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months. |
|
| 1 year |
| Probability of no PSA Failure | Cumulative probability (%) and 95% confidence interval (CI) for completing the study without PSA failure. PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (lowest level of PSA achieved). | 1 year |
| Serum Levels of PSA Over Time | 1 year |
| Serum Levels of Follicle Stimulating Hormone (FSH) Over Time | 1 year |
| Serum Levels of Luteinizing Hormone (LH) Over Time | 1 year |
| Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value. | Baseline up to 1 year |
| Liver Function Tests | 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. | 1 year |
| Laguna Woods |
| California |
| 92653 |
| United States |
| South Florida Medical Research | Aventura | Florida | 33180 | United States |
| Florida Foundation for Healthcare Research | Ocala | Florida | 34474 | United States |
| Regional Urology | Shreveport | Louisiana | 71106 | United States |
| Investigational site | Carmel | New York | 10512 | United States |
| The Urology Center | Greensboro | North Carolina | 27403 | United States |
| State College Urologic Association | State College | Pennsylvania | 16801 | United States |
| Grand Strand Urology | Myrtle Beach | South Carolina | 29572 | United States |
| Urology of Virginia Research | Norfolk | Virginia | 23502 | United States |
| Urology Research Center | Seattle | Washington | 98166 | United States |
| Investigational site | Surrey | British Columbia | Canada |
| Investigational site | Victoria | British Columbia | Canada |
| Investigational site | Kentville | Nova Scotia | Canada |
| The Female/Male Health Centres | Ontario | Canada |
| Nemocnice Jindrichuv Hradec a.s. | Hradec | Czechia |
| Slezska nemocnice | Opava | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | Czechia |
| Dombóvári Szent Lukács Egészségügyi Kht | Dombóvár | Hungary |
| Borsod-Abaúj-Zemplé n Megyei Kórház és Egyetemi Oktató Kórház | Miskolc | Hungary |
| Miskolc Megyei Jogú Város Önkormányzat Miskolci Egészségügyi Központ | Miskolc | Hungary |
| Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ | Szeged | Hungary |
| Private Medical Center | Arad | Romania |
| "Prof Dr Th Burghele" Clinical Hospital | Bucharest | Romania |
| Dinu Uromedica | Bucharest | Romania |
| Fundeni Clinical Institute | Bucharest | Romania |
| E-Uro Medical Center S.R.L. | Cluj-Napoca | Romania |
| Provita Center | Constanța | Romania |
| Sibiu County Clinical Hospital | Sibiu | Romania |
Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Degarelix 240/360 mg | Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months. |
| BG001 | Degarelix 240/480 mg | Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | ITT population. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | ITT population. | Count of Participants | Participants |
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| Race (NIH/OMB) | ITT population. | Count of Participants | Participants |
| |||||||||||||||
| Weight | ITT population. | Mean | Standard Deviation | kilogram |
| ||||||||||||||
| Body mass index | ITT population. | Mean | Standard Deviation | kilogram per square meter |
| ||||||||||||||
| Curative intent | ITT population. Curative intent refers to radical prostatectomy or radiotherapy. | Number | participants |
| |||||||||||||||
| Gleason Score | 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. Gleason score for 1 patient is missing | Number | participants |
| |||||||||||||||
| Stage of Prostate Cancer | 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. | Number | participants |
| |||||||||||||||
| Time Since Prostate Cancer Diagnosis | Mean | Standard Deviation | days |
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| Serum Testosterone | ITT population. | Median | Full Range | ng/mL |
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| Serum PSA | ITT population. | Median | Full Range | ng/mL |
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| Serum FSH | Median | Full Range | IU/L |
| |||||||||||||||
| Serum LH | Median | Full Range | IU/L |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364 | Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364. | Posted | Mean | 95% Confidence Interval | percentage of participants | 1 year |
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| Secondary | Serum Levels of Testosterone Over Time | Posted | Median | Full Range | ng/mL | 1 year |
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| Secondary | Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364 | Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 56 to Day 364. | Posted | Mean | 95% Confidence Interval | percentage of participants | 1 year |
|
| ||||||||||||||||||||||||||||||
| Secondary | Probability of no PSA Failure | Cumulative probability (%) and 95% confidence interval (CI) for completing the study without PSA failure. PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (lowest level of PSA achieved). | Posted | Mean | 95% Confidence Interval | percentage of participants | 1 year |
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| Secondary | Serum Levels of PSA Over Time | Posted | Median | Full Range | ng/mL | 1 year |
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| Secondary | Serum Levels of Follicle Stimulating Hormone (FSH) Over Time | Posted | Median | Full Range | IU/L | 1 year |
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| Secondary | Serum Levels of Luteinizing Hormone (LH) Over Time | Posted | Median | Full Range | IU/L | 1 year |
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| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value. | Posted | Number | participants | Baseline up to 1 year |
|
| |||||||||||||||||||||||||||||||
| Secondary | Liver Function Tests | 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. | Posted | Number | participants | 1 year |
|
|
1 year.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Degarelix 240/360 mg | Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months. | 7 | 67 | 49 | 67 | ||
| EG001 | Degarelix 240/480 mg | Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months. | 11 | 66 | 53 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
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| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Inguinal hernia strangulated | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Mechanical ileus | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Death | General disorders | MedDRA (10.1) | Systematic Assessment |
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| Bile duct obstruction | Hepatobiliary disorders | MedDRA (10.1) | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA (10.1) | Systematic Assessment |
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| Bronchopneumonia | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Lyme disease | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Systematic Assessment |
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| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Systematic Assessment |
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| Depressed level of consciousness | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
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| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA (10.1) | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA (10.1) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (10.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (10.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (10.1) | Systematic Assessment |
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| Weight increased | Investigations | MedDRA (10.1) | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA (10.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
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| Testicular atrophy | Reproductive system and breast disorders | MedDRA (10.1) | Systematic Assessment |
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| Gynaecomastia | Reproductive system and breast disorders | MedDRA (10.1) | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ferring Pharmaceuticals | Clinical Development Support | DK0-Disclosure@ferring.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| No |
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| 5-6 |
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| 7-10 |
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| Data missing |
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| Locally advanced |
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| Metastatic |
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| Not classifiable |
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