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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019632-12 | EudraCT Number |
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The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve [AUC1-85day] for serum testosterone in patients with advanced prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM. | Other |
| |
| Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC. | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorelin Pamoate (Pamorelin® LA 11.25 mg) | Drug | Pamorelin® LA 11.25 mg administered as standard IM injection (= reference group) at Day 1 and Day 85. Triptorelin Pamoate (Pamorelin® LA 11.25 mg) applied subcutaneously (s.c.) at Day 1 and Day 85. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d). | Area under the curve (AUC) calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 85 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method. | 1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d) | Area under the curve calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kreiskrankenhaus, Abteilung Urologie | Bad Bergzaben | 76887 | Germany | |||
| Praxis für Urologie |
109 patients screened and 6 of these did not fulfil randomisation criteria therefore 103 patients were randomised to either group of treatment with triptorelin pamoate 3-month formulation applied intramuscularly or subcutaneously.
Patients diagnosed with advanced prostate cancer (locally advanced or metastatic, histologically proven) recruited at 23 investigational sites in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC. | Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85. |
| FG001 | Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose |
| Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d) | Area under the curve calculated from serum testosterone concentration taken at intervals between Day 85 and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method. | 85, 87, 113, 141 and 169 days post-dose |
| Maximum Concentration of Serum Testosterone [Cmax] - Raw Data | Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169. | 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose |
| Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data | Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169. | 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose |
| Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL | tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than or equal to 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator. | 12 weeks |
| Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL | tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator. | 12 weeks |
| Bad Ems |
| Germany |
| Praxis für Urologie | Bamberg | 96047 | Germany |
| Praxis für Urologie | Berlin | Germany |
| Praxis für Urologie | Braunschweig | Germany |
| Praxis für Urologie | Cham | Germany |
| Praxis für Urologie | Chemnitz | Germany |
| Praxis für Urologie | Dessau | Germany |
| Praxis für Urologie | Eisleben Lutherstadt | Germany |
| Loretto Krankenhaus, Abteilung Urologie | Freiburg im Breisgau | 79100 | Germany |
| Praxis für Urologie | Gelsenkirchen | Germany |
| Praxis für Urologie | Herzberg | Germany |
| Praxis für Urologie | Marburg | Germany |
| Praxis für Urologie | Markkleeberg | Germany |
| Praxis für Urologie | Miltenberg | Germany |
| Praxis für Urologie | Mülheim | Germany |
| Praxis für Urologie | München | 81241 | Germany |
| Praxis für Urologie | Neunkirchen | Germany |
| Urologische Klinik | Neunkirchen | Germany |
| Praxis für Urologie | Reutlingen | 72764 | Germany |
| Praxis für Urologie | Wesel | Germany |
| Praxis für Urologie | Wuppertal | Germany |
Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
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| NOT COMPLETED |
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Analysed from intent-to-treat (ITT) population comprised of 103 patients (SC: 52 and IM: 51 patients).
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| ID | Title | Description |
|---|---|---|
| BG000 | Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC. | Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85. |
| BG001 | Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM. | Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Karnofsky index (%) | Karnofsky index is a measure of performance status to quantify cancer patients' general well-being and activities of daily life. Karnofsky scores run from 100% (perfect health) to 0% (death). Analysed from Intent-to-treat (ITT) population comprised of 103 patients (SC:52 patients and IM:51 patients). | Number | participants |
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| Prostate specific antigen (PSA) level | Analysed from Intent-to-treat (ITT) population with one missing value in the IM group. | Mean | Standard Deviation | ng/mL |
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| Testosterone serum level | Analysed from Intent-to-treat (ITT) population comprised of 103 patients (SC:52 patients and IM:51 patients). | Mean | Standard Deviation | ng/mL |
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| Tumour-related pain | Analysed from modified ITT population comprised of 98 patients (SC: 49 and IM: 49 patients). Tumour-related pain at baseline was rated by the patient by means of a 10-cm visual analogue scale (VAS), ranging from 0 (no pain) to 10 (maximum pain). | Mean | Standard Deviation | cm |
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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 | Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d). | Area under the curve (AUC) calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 85 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method. | Analysed from ITT population. | Posted | Mean | Standard Deviation | log(ng*day/mL) | 1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose |
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| Secondary | Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d) | Area under the curve calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method. | Posted | Mean | Standard Deviation | log(ng*day/mL) | 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose |
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| Secondary | Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d) | Area under the curve calculated from serum testosterone concentration taken at intervals between Day 85 and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method. | 95 patients (IM: 47 patients, SC: 48 patients) received a second injection of the study drug. | Posted | Mean | Standard Deviation | log(ng*day/mL) | 85, 87, 113, 141 and 169 days post-dose |
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| Secondary | Maximum Concentration of Serum Testosterone [Cmax] - Raw Data | Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169. | Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients). | Posted | Mean | Standard Deviation | ng/mL | 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose |
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| Secondary | Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data | Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169. | Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients). | Posted | Mean | Standard Deviation | log(ng/mL) | 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose |
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| Secondary | Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL | tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than or equal to 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator. | Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients). | Posted | Median | 95% Confidence Interval | days | 12 weeks |
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| Secondary | Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL | tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator. | Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients). | Posted | Median | 95% Confidence Interval | days | 12 weeks |
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Throughout the treatment period: 169 days.
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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 | Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC. | Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85. | 11 | 52 | 32 | 52 | ||
| EG001 | Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM. | Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85. | 7 | 51 | 25 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Bladder outlet obstruction | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
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| Mediastinitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
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| Peritonitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
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| Pyuria | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Rectal abscess | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Urethral stenosis | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Uro-oncology | Ipsen | clinical.trials@ipsen.com | clinical.trials@ipsen.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 |
|---|---|
| D017329 | Triptorelin Pamoate |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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| 60 to < 70 years |
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| 70 to < 80 years |
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| 80 to < 90 years |
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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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| 90% |
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| 80% |
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