Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-07 @ 7:27 AM
Study NCT ID:
NCT01415960
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2011-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Leuprolide Acetate 22.5 mg Depot in Treatment of Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016729', 'term': 'Leuprolide'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nshore@grandstrandurology.com', 'phone': '+1 843 839 1679', 'title': 'Dr. Neal Shore MD', 'organization': 'Grand Strand Urology Carolina Urology Reseearch Centre'}, 'certainAgreement': {'otherDetails': 'All information from the trial is property of the Sponsor and the PI has no right on it except the prior writing authorization of the sponsor', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Leuprolide Acetate 22.5 mg Depot', 'description': 'Leuprolide acetate 22.5 mg depot administered twice, 3 months apart\n\nLeuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im injection, twice during the study, three months apart', 'otherNumAtRisk': 163, 'otherNumAffected': 141, 'seriousNumAtRisk': 163, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'TEAE Related Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'General disorders'}, {'term': 'TEAE Related Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'General disorders'}, {'term': 'TEAE Related Hot Flushes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 146, 'numAffected': 126}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'CONGESTIVE HEART FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'DIARRHEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'INCARCERATED INGUINAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'RECTAL BLEEDING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'NON-CARDIAC CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'DIABETIC KETOACIDOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'BENIGN NEOPLASM OF BLADDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Chemical Castration (Defined as Testosterone Levels ≤ 0.5 ng/mL) at Days 28, 84, and 168.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Leuprolide Acetate 22.5 mg Depot', 'description': 'Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.\n\nLeuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '94.7', 'upperLimit': '99.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '168 days', 'description': 'The primary endpoint was testosterone ≤ 0.5 ng/mL assessed on Days 28, 84, and 168. Thereby, maintenance of castration was to be demonstrated through Day 168 with no missing data at these key time points, unless the missing data were due to an event unrelated to the study drug (ITT patients).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Determination of Serum Luteinizing Hormone (LH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Leuprolide Acetate 22.5 mg Depot', 'description': 'Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.\n\nLeuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.24', 'spread': '6.48', 'groupId': 'OG000'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '1', 'spread': '2.79', 'groupId': 'OG000'}]}]}, {'title': 'Day 168', 'categories': [{'measurements': [{'value': '1', 'spread': '0.92', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '168 days', 'description': 'For purposes of calculating summary statistics, any concentration values Below Limit of Quantification (BLQ) were to be assigned ½ the Low Limit of Quantification (LLOQ) (LLOQ=2.00). If the calculated mean, median or minimum value at a time point was less than LLOQ, "BLQ" is presented. In addition, since a high proportion of BLQ values may affect the Standard Deviation (SD); if more than 50% of values were imputed, then no mean or median was calculated for that time point.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Follicle-stimulating Hormone (FSH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Leuprolide Acetate 22.5 mg Depot', 'description': 'Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.\n\nLeuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '15.14', 'spread': '13.46', 'groupId': 'OG000'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '1', 'spread': '1.44', 'groupId': 'OG000'}]}]}, {'title': 'Day 168', 'categories': [{'measurements': [{'value': '5.80', 'spread': '3.62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '168 days', 'description': 'For purposes of calculating summary statistics, any concentration values Below Limit of Quantification (BLQ) were to be assigned ½ the Low Limit of Quantification (LLOQ) (LLOQ=3.66). If the calculated mean, median or minimum value at a time point was less than LLOQ, "BLQ" is presented. In addition, since a high proportion of BLQ values may affect the Standard Deviation (SD); if more than 50% of values were imputed, then no mean or median was to be calculated for that time point.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Prostate-specific Antigen (PSA) Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Leuprolide Acetate 22.5 mg Depot', 'description': 'Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.\n\nLeuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '44.36', 'spread': '165.81', 'groupId': 'OG000'}]}]}, {'title': 'Day 168', 'categories': [{'measurements': [{'value': '2.37', 'spread': '10.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '168 days', 'description': 'For purposes of calculating summary statistics, any concentration values Below Limit Quantification (BLQ) were to be assigned ½ the Low Limit Quantification (LLOQ) (LLOQ=0.36). If the calculated mean, median or minimum value at a time point was less than LLOQ, "BLQ" is presented. In addition, since a high proportion of BLQ values may affect the Standard Deviation (SD); if more than 50% of values were imputed, then no mean or median was calculated for that time point.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Determination of Leuprolide Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Leuprolide Acetate 22.5 mg Depot', 'description': 'Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.\n\nLeuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart.'}], 'classes': [{'title': 'Day 0/Dose 1 Cmax', 'categories': [{'measurements': [{'value': '46.79', 'spread': '18.008', 'groupId': 'OG000'}]}]}, {'title': 'Day 84/Dose 2 Cmax', 'categories': [{'measurements': [{'value': '48.30', 'spread': '18.557', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cmax1: 0, 1 and 4 hours post-dose on Day 0 and once on Days 2, 14, 28, 56; Cmax2: 0, 1 and 4 hours post-dose on Day 84 and once on Days 86, 112 and 168.', 'description': 'Leuprolide Pharmacokinetic Parameters (PK Population).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety Endpoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Leuprolide Acetate 22.5 mg Depot', 'description': 'Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.\n\nLeuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart.'}], 'classes': [{'title': 'Baseline WHO/ECOG Score 0 (n=161)', 'categories': [{'measurements': [{'value': '83.9', 'groupId': 'OG000'}]}]}, {'title': 'Day 168 WHO/ECOG Scores 0 (n=152)', 'categories': [{'measurements': [{'value': '82.9', 'groupId': 'OG000'}]}]}, {'title': 'Baseline Bone Pain score 1 (n=161)', 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000'}]}]}, {'title': 'Day 168 Bone Pain score 1 (n=152)', 'categories': [{'measurements': [{'value': '94.1', 'groupId': 'OG000'}]}]}, {'title': 'Baseline Urinary Pain score 1 (n=161)', 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000'}]}]}, {'title': 'Day 168 Urinary Pain Score 1 (n=152)', 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000'}]}]}, {'title': 'Baseline Urinary Symptoms score 1 (n=161)', 'categories': [{'measurements': [{'value': '87.6', 'groupId': 'OG000'}]}]}, {'title': 'Day 168 Urinary Symptoms score 1 (n=152)', 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '168 Days', 'description': 'The WHO/ECOG, bone pain, urinary pain and urinary symptoms data reported are the most frequent percentage at the assessment time.\n\n* The WHO/ECOG performance status was summarized using the 0 to 4 WHO/ECOG performance status scale. (0= fully active, able to carry on all pre-disease performances without restriction).\n* Bone pain, urinary pain and urinary symptoms were determined using a 10-point scale (1= no pain/symptoms, 10= worst pain/symptom imaginable).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety endpoints adverse events (AEs), local tolerability, vital signs, performance status, bone pain, urinary pain, and urinary symptoms, occurrence of hot flushes and clinical laboratory and electrocardiogram (ECG) results.'}, {'type': 'SECONDARY', 'title': 'Determination of Leuprolide Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Leuprolide Acetate 22.5 mg Depot', 'description': 'Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.\n\nLeuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart.'}], 'classes': [{'title': 'Day 0/Dose 1 Tmax', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.051', 'groupId': 'OG000'}]}]}, {'title': 'Day 84/Dose 2 Tmax', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.056', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '84 days', 'description': 'Leuprolide Pharmacokinetic Parameters (PK Population).', 'unitOfMeasure': 'day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Leuprolide Acetate 22.5 mg Depot', 'description': 'Leuprolide acetate 22.5 mg depot administered twice, 3 months apart\n\nLeuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im injection, twice during the study, three months apart'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}]}, {'type': 'ITT', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}]}, {'type': 'PK Subgroup', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Patients completed Study (151) Per protocol Patients (146)', 'groupId': 'FG000', 'numSubjects': '151'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Leuprolide Acetate 22.5 mg Depot', 'description': 'Leuprolide acetate 22.5 mg depot administered twice, 3 months apart\n\nLeuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im injection, twice during the study, three months apart'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '119', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71', 'spread': '9.02', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '161', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '161', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-19', 'studyFirstSubmitDate': '2011-08-11', 'resultsFirstSubmitDate': '2015-07-23', 'studyFirstSubmitQcDate': '2011-08-11', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-21', 'studyFirstPostDateStruct': {'date': '2011-08-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Chemical Castration (Defined as Testosterone Levels ≤ 0.5 ng/mL) at Days 28, 84, and 168.', 'timeFrame': '168 days', 'description': 'The primary endpoint was testosterone ≤ 0.5 ng/mL assessed on Days 28, 84, and 168. Thereby, maintenance of castration was to be demonstrated through Day 168 with no missing data at these key time points, unless the missing data were due to an event unrelated to the study drug (ITT patients).'}], 'secondaryOutcomes': [{'measure': 'Determination of Serum Luteinizing Hormone (LH)', 'timeFrame': '168 days', 'description': 'For purposes of calculating summary statistics, any concentration values Below Limit of Quantification (BLQ) were to be assigned ½ the Low Limit of Quantification (LLOQ) (LLOQ=2.00). If the calculated mean, median or minimum value at a time point was less than LLOQ, "BLQ" is presented. In addition, since a high proportion of BLQ values may affect the Standard Deviation (SD); if more than 50% of values were imputed, then no mean or median was calculated for that time point.'}, {'measure': 'Follicle-stimulating Hormone (FSH)', 'timeFrame': '168 days', 'description': 'For purposes of calculating summary statistics, any concentration values Below Limit of Quantification (BLQ) were to be assigned ½ the Low Limit of Quantification (LLOQ) (LLOQ=3.66). If the calculated mean, median or minimum value at a time point was less than LLOQ, "BLQ" is presented. In addition, since a high proportion of BLQ values may affect the Standard Deviation (SD); if more than 50% of values were imputed, then no mean or median was to be calculated for that time point.'}, {'measure': 'Prostate-specific Antigen (PSA) Concentrations', 'timeFrame': '168 days', 'description': 'For purposes of calculating summary statistics, any concentration values Below Limit Quantification (BLQ) were to be assigned ½ the Low Limit Quantification (LLOQ) (LLOQ=0.36). If the calculated mean, median or minimum value at a time point was less than LLOQ, "BLQ" is presented. In addition, since a high proportion of BLQ values may affect the Standard Deviation (SD); if more than 50% of values were imputed, then no mean or median was calculated for that time point.'}, {'measure': 'Determination of Leuprolide Cmax', 'timeFrame': 'Cmax1: 0, 1 and 4 hours post-dose on Day 0 and once on Days 2, 14, 28, 56; Cmax2: 0, 1 and 4 hours post-dose on Day 84 and once on Days 86, 112 and 168.', 'description': 'Leuprolide Pharmacokinetic Parameters (PK Population).'}, {'measure': 'Safety Endpoints', 'timeFrame': '168 Days', 'description': 'The WHO/ECOG, bone pain, urinary pain and urinary symptoms data reported are the most frequent percentage at the assessment time.\n\n* The WHO/ECOG performance status was summarized using the 0 to 4 WHO/ECOG performance status scale. (0= fully active, able to carry on all pre-disease performances without restriction).\n* Bone pain, urinary pain and urinary symptoms were determined using a 10-point scale (1= no pain/symptoms, 10= worst pain/symptom imaginable).'}, {'measure': 'Determination of Leuprolide Tmax', 'timeFrame': '84 days', 'description': 'Leuprolide Pharmacokinetic Parameters (PK Population).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'androgen deprivation therapy.', 'Leuprolide Acetate Depot Formulation', 'Pharmacokinetics', 'testosterone', 'serum luteinizing hormone', 'follicle-stimulating hormone', 'prostate-specific antigen'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '30929678', 'type': 'DERIVED', 'citation': 'Shore ND, Guerrero S, Sanahuja RM, Gambus G, Parente A. A New Sustained-release, 3-Month Leuprolide Acetate Formulation Achieves and Maintains Castrate Concentrations of Testosterone in Patients With Prostate Cancer. Clin Ther. 2019 Mar;41(3):412-425. doi: 10.1016/j.clinthera.2019.01.004. Epub 2019 Feb 8.'}]}, 'descriptionModule': {'briefSummary': 'Some patients with prostate cancer benefit from androgen deprivation therapy which reduces levels of testosterone. Leuprolide is a synthetic Luteinizing hormone releasing hormone (LHRH) analogue which upon administration can decrease testosterone levels to ≤0.5 ng/mL. Leuprolide Acetate 22.5 mg Depot is a microencapsulated formulation of leuprolide which is released slowly over time and effectively reduces testosterone levels in many patients to ≤0.5 ng/mL for up to three months. In this study Leuprolide acetate 22.5 mg Depot will be administered by intramuscular injection twice over a period of 6 months. The proportion of patients with testosterone ≤0.5 ng/mL evaluated over a period of 168 days.', 'detailedDescription': 'This in an open-label, multicenter, multiple-dose investigation of 2 doses of leuprolide acetate 22.5 mg administered with a 3-month interval to patients with histologically proven carcinoma of prostate who might benefit from medical androgen deprivation therapy. A total of up to 160 male patients will receive their first single intramuscular injection of leuprolide acetate 22.5 mg on Day 0 (after baseline assessment) and then after 3 months (Day 84). The study duration will be 6 months. Thirty(30) patients will be screened per protocol and enrolled at selected centers to form the PK cohort. The PK/PD analysis will be performed using plasma specimens from the first 20 of 30 patients enrolled in the study (and included in the PK/PD cohort). Patients not belonging to the PK cohort will be screened and enrolled per protocol and will follow the same study schedule as those enrolled in the PK portion of the study, except they will provide only sparse PK sampling.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Main selection criteria:\n\nPatients with histologically documented prostate cancer who might benefit from medical androgen deprivation therapy (i.e., reduction of androgen levels) will be considered for enrollment in the study if they meet the following criteria:\n\nInclusion Criteria:\n\n1. Males ≥18 years of age\n2. Patients with histologically documented prostate carcinoma who might benefit from medical androgen deprivation therapy.\n3. Life expectancy of at least 1 year.\n4. WHO/ECOG performance status of 0, 1, or 2.\n5. Adequate renal function at Screening as defined by serum creatinine ≤1.6 times the upper limit of normal (ULN) for the clinical laboratory.\n6. Adequate and stable hepatic function as defined by bilirubin ≤1.5 times the ULN and transaminases (i.e., aspartate aminotransferase, alanine aminotransferase) ≤2.5 times the ULN for the clinical laboratory at Screening.\n7. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study.\n8. Following receipt of verbal and written information about the study,the patient must provide signed informed consent before any study related activity is carried out.\n\nExclusion Criteria:\n\n1. Evidence of brain metastases, in the opinion of the investigator, taking into account medical history, clinical observations, and symptoms (rationale: to minimize possibility of serious acute flare reactions that would necessitate concomitant administration of other drugs).\n2. Evidence of spinal cord compression, in the opinion of the investigator, taking into account medical history, clinical observations, and symptoms (rationale: see rationale in criterion 1).\n3. Evidence of severe urinary tract obstruction with threatening urinary retention, in the opinion of the investigator, taking into account medical history, clinical observations, and symptoms (rationale: see rationale in criterion 1).\n4. Presence of any tumor in the immediate vicinity that could cause spinal cord compression, in the opinion of the investigator, taking into account medical history and clinical observations (rationale: see rationale in criterion 1).\n5. Excruciating, severe pain from extensive osseous deposits, taking into account medical history, clinical observations, and symptoms (rationale: see rationale in criterion 1).\n6. Testosterone levels \\<1.5 ng/mL at Screening, This testosterone level will be locally determined at the laboratory of each clinical site (rationale: to ensure that all patients have normal baseline testosterone levels).\n7. Previous androgen ablative therapy lasting more than 6 months, such as LHRH analogues (e.g., Leuprolide acetate, Goserelin, Buserelin) or antagonists (degarelix). Also, therapy must have not occurred within 12 months before the screening visit. Any prior ADT must have not exceeded 6 months of therapy.\n8. Previous treatment with androgen-receptor blockers, such as Bicalutamide, Flutamide, Megestrol acetate, Ciproterone will only be allowed after a 3 month washout prior to the screening visit (rationale: these therapies alter a patient's androgenic hormonal response for a sustained period).\n9. Previous orchiectomy, adrenalectomy, or hypophysectomy (no washout allowed) (rationale: these therapies could have altered a patient's androgenic hormonal response).\n10. Previous prostatic surgery (e.g., radical prostatectomy, transurethral resection of the prostate) within 2 weeks before Baseline (rationale: these therapies could have altered a patient's androgenic hormonal response and/or adverse reaction profile).\n11. Previous local therapy to the primary tumor with a curative attempt other than surgery (external beam radiotherapy, brachytherapy, thermotherapy, cryotherapy) within 2 weeks before Baseline (rationale: these therapies could have altered a patient's adverse reaction profile).\n12. Previous cancer systemic therapy such as chemotherapy, immunotherapy (e.g., antibody therapies, tumor vaccines), biological response modifiers (e.g., cytokines).\n13. Any investigational drug within 5 half-lives of its physiological action or 3 months, whichever is longer, before Baseline (rationale: to prevent adverse effects of another drug being attributed to study drug and to prevent potential interactions).\n14. Administration of 5-α-reductase inhibitors (Finasteride, Dutasteride) within 3 months before Baseline (rationale: alters PSA levels and androgen metabolism of the prostate cells). Prior use of 5-α-reductase inhibitors will be allowed with a 3 month washout.\n15. Over-the-counter or alternative medical therapies that have an estrogenic or antiandrogenic effect (i.e., PC-SPES, saw palmetto, Glycyrrhiza, Urinozinc, dehydroepiandrosterone) within the 3 months before Baseline.\n16. Hematological parameters (red blood cells, total and differential white blood cell count, platelet count, hemoglobin, hematocrit) outside 20% of the ULN or lower limits of normal for the clinical laboratory at Screening (rationale: to render potential study drug-related laboratory abnormalities easier to observe).\n17. Coexistent malignancy, in the opinion of the investigator (rationale: to decrease possibility of disease-caused or associated therapy-caused adverse effects being attributed to study drug).\n18. Uncontrolled congestive heart failure, myocardial infarction or a coronary vascular procedure (e.g., balloon angioplasty, coronary artery bypass graft) or significant symptomatic cardiovascular disease(s) within 6 months before Baseline; resting uncontrolled hypertension (≥160/100 mm Hg) or symptomatic hypotension within 3 months before Baseline (rationale: to decrease possibility of disease-caused or associated therapy-caused adverse effects being attributed to study drug).\n19. Venous thrombosis within 6 months of Baseline (rationale: influencing testosterone levels may be associated with increased likelihood of deep venous thrombosis).\n20. Uncontrolled diabetes, in the opinion of the investigator (rationale:\n\n patients with uncontrolled diabetes need to compensate the metabolic disorder before treatment with LHRH analogues).\n21. History of drug and/or alcohol abuse within 6 months of Baseline (rationale: these patients are likely to have numerous medical abnormalities and are unlikely to comply with protocol).\n22. Serious concomitant illness(es) or disease(s) (e.g., hematological, renal, hepatic, respiratory, endocrine, psychiatric) that may interfere with, or put patients at additional risk for, their ability to receive the treatment outlined in the protocol (rationale: to decrease possibility of disease-caused or associated therapy-caused adverse effects being attributed to study drug).\n23. Patients on anticoagulative therapy including warfarin (Coumadin®), Dabigatran Etexilate (Pradaxa®) and heparin. Those patients on low-dose, low-molecular weight heparin may be enrolled in the study (rationale: to decrease possibility of disease-caused or associated therapy-caused adverse effects being attributed to study drug). Plavix and Aspirin are allowed for cardiac prophylaxis as long as all inclusion/exclusion criteria are met concerning coagulation parameters and thromboembolic history. Special care to avoid hematoma at the injection site must be observed.\n24. Abnormal coagulation studies (prothrombin time \\[PT\\]/partial thromboplastin time \\[PTT\\]) at Baseline.\n25. History of serious bleeding on injections, an elevated INR, concomitant medications or any other condition (i.e. significant thrombocytopenia) that in opinion of the investigator would render the subject at risk of significant bleeding with injections.\n26. Blood donations/losses within 2 months of Baseline, apart from previous prostatic surgery patients (see exclusion 10 \\[rationale: to avoid excessive blood donations\\]).\n27. Known hypersensitivity to GnRH, GnRH agonists, including any LHRH analogues, or any excipients of the study formulation (rationale: to minimize hypersensitivity reaction to study drug).\n28. History of Immunization (within 4 weeks of Baseline) and specifically flu shots (within 1 week of Baseline or 1 week before and after study drug administration) (Rationale: to decrease the possibility of non treatment-related AEs being attributed to study drug).\n29. Skin disease that would interfere with injection site evaluation.\n30. Men not willing to use appropriate birth control methods such as surgical sterilization or barrier contraception or men with partners of child bearing potential not willing to use appropriate birth control methods, such as surgical sterilization, hormonal birth control (partner), an intrauterine device (partner) or double-barrier method for the entire study period."}, 'identificationModule': {'nctId': 'NCT01415960', 'briefTitle': 'Efficacy and Safety of Leuprolide Acetate 22.5 mg Depot in Treatment of Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'GP-Pharm'}, 'officialTitle': 'Efficacy and Safety of a New Leuprolide Acetate 22.5 mg Depot Formulation in the Treatment of Prostate Cancer', 'orgStudyIdInfo': {'id': 'GP/C/05/PRO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Leuprolide acetate 22.5 mg depot', 'description': 'Leuprolide acetate 22.5 mg depot administered twice, 3 months apart', 'interventionNames': ['Drug: Leuprolide acetate 22.5 mg depot, GP-Pharm SA']}], 'interventions': [{'name': 'Leuprolide acetate 22.5 mg depot, GP-Pharm SA', 'type': 'DRUG', 'description': 'Administered by im injection, twice during the study, three months apart', 'armGroupLabels': ['Leuprolide acetate 22.5 mg depot']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Genesis Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32114', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Atlantic Urological Associates', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '34474', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Urology Health Team', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Winter Park Urology Associates, PA', 'geoPoint': 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