NCT01386684 is a clinical trial in Prostate Cancer, sponsored by AbbVie (prior sponsor, Abbott).

Who is sponsoring NCT01386684?

NCT01386684 is sponsored by AbbVie (prior sponsor, Abbott).

What condition does NCT01386684 study?

NCT01386684 studies Prostate Cancer.

Is NCT01386684 still recruiting?

NCT01386684 is currently completed. Last updated 13 December 2018.

Are results published for NCT01386684?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-12-13 · How we verify

NCT01386684

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Real Life Evaluation of Lupron in the Management of Prostate Cancer: A Canadian Post Marketing Observational Study

Completed Results posted Last updated 13 December 2018

What this trial tests

trial in Prostate Cancer in 552 participants. Completed in 8 September 2016.

Timeline

28 June 2011

Primary endpoint
8 September 2016

8 September 2016

Quick facts

Lead sponsor	AbbVie (prior sponsor, Abbott)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	552
Start date	28 June 2011
Primary completion	8 September 2016
Estimated completion	8 September 2016

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

AbbVie (prior sponsor, Abbott) — full company profile →

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to Biochemical Progression Based on Doubling of Prostate Specific Antigen (PSA) Velocity or PSA > 5.0 Primary · 36 months

PFS defined as the time from patient recruitment to biochemical progression based on doubling of prostate specific antigen (PSA) velocity or PSA \> 5.0, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.

Group	Value	95% CI
Patients With Prostate Cancer	20.76	± 0.59

Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to a Change to an Absolute Value of PSA > 2 ng/mL on at Least 2 Consecutive Tests Primary · 36 months

A second definition of PFS was used due to changes in the definition of biochemical progression: the time from patient recruitment to a change to an absolute value of PSA \> 2 ng/mL on at least 2 consecutive tests, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.

Group	Value	95% CI
Patients With Prostate Cancer	21.89	± 0.69

Castration Resistant Prostate Cancer (CRPC): Number of Participants Secondary · 36 months

CRPC defined as PSA \> 2 ng/mL on at least 2 consecutive tests.

Group	Value	95% CI
Patients With Prostate Cancer	84

Castration Resistant Prostate Cancer (CRPC): Time to Event Secondary · 36 months

CRPC defined as PSA \> 2 ng/mL on at least 2 consecutive tests. The distribution of time to CRPC was estimated using Kaplan-Meier methodology. The point estimate and standard error of the distribution are provided.

Group	Value	95% CI
Patients With Prostate Cancer	26.01	± 0.42

Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Secondary · Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36

Total serum testosterone was assessed at each study visit. The percentage of participants with total serum testosterone ≤ 0.7 nmol/L, \> 0.7 to ≤ 1.7 nmol/L, and \> 1.7 nmol/L are provided at each time point.

Month 0: ≤ 0.7 nmol/L

Group	Value	95% CI
Patients With Prostate Cancer	16.3

Month 3: ≤ 0.7 nmol/L

Group	Value	95% CI
Patients With Prostate Cancer	65.3

Month 6: ≤ 0.7 nmol/L

Group	Value	95% CI
Patients With Prostate Cancer	62.9

Month 12: ≤ 0.7 nmol/L

Group	Value	95% CI
Patients With Prostate Cancer	68.8

Month 18: ≤ 0.7 nmol/L

Group	Value	95% CI
Patients With Prostate Cancer	69.0

Month 24: ≤ 0.7 nmol/L

Group	Value	95% CI
Patients With Prostate Cancer	68.8

Month 30: ≤ 0.7 nmol/L

Group	Value	95% CI
Patients With Prostate Cancer	69.2

Month 36: ≤ 0.7 nmol/L

Group	Value	95% CI
Patients With Prostate Cancer	55.7

Total Serum Testosterone Levels at Each Visit Secondary · Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36

Total serum testosterone was assessed at each study visit.

Month 0

Group	Value	95% CI
Patients With Prostate Cancer	10.9	± 8.90

Month 3

Group	Value	95% CI
Patients With Prostate Cancer	0.6	± 0.98

Month 6

Group	Value	95% CI
Patients With Prostate Cancer	1.0	± 2.32

Month 12

Group	Value	95% CI
Patients With Prostate Cancer	1.5	± 3.29

Month 18

Group	Value	95% CI
Patients With Prostate Cancer	1.9	± 4.05

Month 24

Group	Value	95% CI
Patients With Prostate Cancer	2.1	± 4.31

Month 30

Group	Value	95% CI
Patients With Prostate Cancer	2.3	± 4.81

Month 36

Group	Value	95% CI
Patients With Prostate Cancer	2.9	± 4.69

Total Serum Testosterone: Time to Increase Over Castrate Levels Secondary · 36 months

Total serum testosterone was assessed at each study visit. The time to increased total serum testosterone over the castrate levels (\>1.7 nmol/L) are provided. The distribution of time to increase in total serum testosterone levels was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.

Group	Value	95% CI
Patients With Prostate Cancer	31.20	± 0.67

Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Secondary · Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36

Serum PSA was assessed at each study visit. The percentage of participants with serum PSA \< 1 ng/mL, 1 to \< 5 ng/mL, 5 to \< 10 ng/mL, and ≥10 ng/mL are provided at each time point.

Month 0: <1 ng/mL

Group	Value	95% CI
Patients With Prostate Cancer	15.2

Month 3: <1 ng/mL

Group	Value	95% CI
Patients With Prostate Cancer	55.9

Month 6: <1 ng/mL

Group	Value	95% CI
Patients With Prostate Cancer	61.8

Month 12: <1 ng/mL

Group	Value	95% CI
Patients With Prostate Cancer	63.6

Month 18: <1 ng/mL

Group	Value	95% CI
Patients With Prostate Cancer	64.6

Month 24: <1 ng/mL

Group	Value	95% CI
Patients With Prostate Cancer	60.7

Month 30: <1 ng/mL

Group	Value	95% CI
Patients With Prostate Cancer	56.9

Month 36: <1 ng/mL

Group	Value	95% CI
Patients With Prostate Cancer	57.5

Prostatic Specific Antigen (PSA) Levels at Each Visit Secondary · Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36

Serum PSA was assessed at each study visit.

Month 0

Group	Value	95% CI
Patients With Prostate Cancer	65.0	± 377.60

Month 3

Group	Value	95% CI
Patients With Prostate Cancer	6.5	± 41.33

Month 6

Group	Value	95% CI
Patients With Prostate Cancer	12.0	± 80.64

Month 12

Group	Value	95% CI
Patients With Prostate Cancer	19.1	± 128.51

Month 18

Group	Value	95% CI
Patients With Prostate Cancer	13.3	± 113.98

Month 24

Group	Value	95% CI
Patients With Prostate Cancer	11.2	± 56.69

Month 30

Group	Value	95% CI
Patients With Prostate Cancer	13.5	± 65.79

Month 36

Group	Value	95% CI
Patients With Prostate Cancer	8.2	± 37.12

Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit Secondary · Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

The FACT-G questionnaire is used with patients of any tumor type to assess patient quality of life (QoL). FACT-G is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). The FACT-G total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-G was analyzed using repeate

Month 3

Group	Value	95% CI
Patients With Prostate Cancer	-0.9	± 0.6

Month 6

Group	Value	95% CI
Patients With Prostate Cancer	-2.2	± 0.6

Month 12

Group	Value	95% CI
Patients With Prostate Cancer	-1.7	± 0.6

Month 18

Group	Value	95% CI
Patients With Prostate Cancer	-1.0	± 0.7

Month 24

Group	Value	95% CI
Patients With Prostate Cancer	-1.4	± 0.7

Month 30

Group	Value	95% CI
Patients With Prostate Cancer	-1.3	± 0.7

Month 36

Group	Value	95% CI
Patients With Prostate Cancer	-1.9	± 0.8

Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit Secondary · Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

The FACT-P questionnaire is used with patients with prostate cancer to assess patient quality of life (QoL). FACT-P is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-P use a 5-point rating scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much). The FACT-P total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-P was analyzed using repe

Month 3

Group	Value	95% CI
Patients With Prostate Cancer	-1.1	± 0.8

Month 6

Group	Value	95% CI
Patients With Prostate Cancer	-2.8	± 0.8

Month 12

Group	Value	95% CI
Patients With Prostate Cancer	-2.4	± 0.9

Month 18

Group	Value	95% CI
Patients With Prostate Cancer	-1.8	± 0.9

Month 24

Group	Value	95% CI
Patients With Prostate Cancer	-2.1	± 0.9

Month 30

Group	Value	95% CI
Patients With Prostate Cancer	-2.3	± 1.0

Month 36

Group	Value	95% CI
Patients With Prostate Cancer	-3.0	± 1.0

International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit Secondary · Month 0 (Baseline) and Months 6, 12, 18, 24, 30, and 36

IIEF-5 is a 5-item, self-administered questionnaire assessing the presence and severity of erectile dysfunction. A score of 1 (very low) to 5 (very high) is awarded to each of the 5 questions. The IIEF-5 total score is a sum of the responses to the 5 items. Total scores range from 5 to 25, with higher scores indicating less dysfunction. Change in IIEF-5 was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates an increase in dysfunction.

Month 6

Group	Value	95% CI
Patients With Prostate Cancer	-2.7	± 0.3

Month 12

Group	Value	95% CI
Patients With Prostate Cancer	-3.2	± 0.3

Month 18

Group	Value	95% CI
Patients With Prostate Cancer	-3.3	± 0.3

Month 24

Group	Value	95% CI
Patients With Prostate Cancer	-3.7	± 0.3

Month 30

Group	Value	95% CI
Patients With Prostate Cancer	-3.5	± 0.3

Month 36

Group	Value	95% CI
Patients With Prostate Cancer	-3.3	± 0.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Patients With Prostate Cancer

Serious: 132/552 (24%)

Deaths: —

Serious adverse events (248 terms)

Reaction	System	Patients With Prostate Can…
PROSTATE CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
FALL	Injury, poisoning and procedural complications	—
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	—
METASTASES TO BONE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	—
ATRIAL FIBRILLATION	Cardiac disorders	—
MYOCARDIAL INFARCTION	Cardiac disorders	—
ASTHENIA	General disorders	—
DEATH	General disorders	—
DISEASE PROGRESSION	General disorders	—
ABDOMINAL PAIN	Gastrointestinal disorders	—
ACUTE KIDNEY INJURY	Renal and urinary disorders	—
ANAEMIA	Blood and lymphatic system disorders	—
PYREXIA	General disorders	—
PNEUMONIA	Infections and infestations	—
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	—
ACUTE CORONARY SYNDROME	Cardiac disorders	—
FATIGUE	General disorders	—
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	—
PAIN	General disorders	—
HIP FRACTURE	Injury, poisoning and procedural complications	—
COLON CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
SYNCOPE	Nervous system disorders	—
DYSURIA	Renal and urinary disorders	—

Other adverse events (133 terms — click to expand)

Reaction	System	Patients With Prostate Can…
HOT FLUSH	Vascular disorders	—
FATIGUE	General disorders	—
DRUG INEFFECTIVE	General disorders	—
PROSTATIC SPECIFIC ANTIGEN INCREASED	Investigations	—
CONSTIPATION	Gastrointestinal disorders	—
ASTHENIA	General disorders	—
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	—
ARTHRALGIA	Musculoskeletal and connective tissue disorders	—
ATRIAL FIBRILLATION	Cardiac disorders	—
DIARRHOEA	Gastrointestinal disorders	—
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	—
CHILLS	General disorders	—
GAIT DISTURBANCE	General disorders	—
PAIN	General disorders	—
URINARY TRACT INFECTION	Infections and infestations	—
DECREASED APPETITE	Metabolism and nutrition disorders	—
HYPOGLYCAEMIA	Metabolism and nutrition disorders	—
HYPOPHAGIA	Metabolism and nutrition disorders	—
BONE PAIN	Musculoskeletal and connective tissue disorders	—
JOINT SWELLING	Musculoskeletal and connective tissue disorders	—
MOBILITY DECREASED	Musculoskeletal and connective tissue disorders	—
MUSCULOSKELETAL STIFFNESS	Musculoskeletal and connective tissue disorders	—
MYALGIA	Musculoskeletal and connective tissue disorders	—
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	—
LUNG NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
DEMENTIA	Nervous system disorders	—
DIZZINESS	Nervous system disorders	—
CONFUSIONAL STATE	Psychiatric disorders	—
HAEMATURIA	Renal and urinary disorders	—
NEPHROLITHIASIS	Renal and urinary disorders	—
COUGH	Respiratory, thoracic and mediastinal disorders	—
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	—
ACTIVITIES OF DAILY LIVING IMPAIRED	Social circumstances	—
HYPOTENSION	Vascular disorders	—
LEUKOCYTE VACUOLISATION	Blood and lymphatic system disorders	—
LYMPHADENOPATHY	Blood and lymphatic system disorders	—
CORONARY ARTERY DISEASE	Cardiac disorders	—
EAR PAIN	Ear and labyrinth disorders	—
OCULAR MYASTHENIA	Eye disorders	—
DYSPHAGIA	Gastrointestinal disorders	—

Most-reported serious reactions: PROSTATE CANCER METASTATIC, FALL, DYSPNOEA, METASTASES TO BONE, PROSTATE CANCER, CARDIAC FAILURE CONGESTIVE, ATRIAL FIBRILLATION, MYOCARDIAL INFARCTION.

Data from ClinicalTrials.gov NCT01386684 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the Canadian Real Life Evaluation of the Effectiveness of Lupron in the Management of Prostate Cancer.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01386684 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie (prior sponsor, Abbott)
Last refreshed: 13 December 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01386684.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01386684

Quick facts

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (248 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Prostate Cancer

Other AbbVie (prior sponsor, Abbott) trials

Verify against primary sources