Trial Outcomes & Findings for Efficacy and Safety of a Triptorelin 6-month Formulation in Patients With Advanced Prostate Cancer (NCT NCT00751790)
NCT ID: NCT00751790
Last Updated: 2014-07-25
Results Overview
Percentage of patients achieving castrate testosterone levels (≤1.735 nmol/L) by Day 29 (28 days after study drug injection) and percentage of patients maintaining castrate testosterone levels from Month 2 to end of Month 12 (Week 48).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
at Day 29
Results posted on
2014-07-25
Participant Flow
Participant milestones
| Measure |
Triptorelin
Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
COMPLETED
|
115
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Triptorelin
Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Death
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Efficacy and Safety of a Triptorelin 6-month Formulation in Patients With Advanced Prostate Cancer
Baseline characteristics by cohort
| Measure |
Triptorelin
n=120 Participants
Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
120 Participants
n=5 Participants
|
|
Age, Continuous
|
71.11 years
STANDARD_DEVIATION 8.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
120 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at Day 29Percentage of patients achieving castrate testosterone levels (≤1.735 nmol/L) by Day 29 (28 days after study drug injection) and percentage of patients maintaining castrate testosterone levels from Month 2 to end of Month 12 (Week 48).
Outcome measures
| Measure |
Triptorelin
n=120 Participants
Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
|
|---|---|
|
Achievement of Castration and Maintenance of Castration
|
97.5 percentage of enrolled patients
|
SECONDARY outcome
Timeframe: day 1 and day 169% of patients showing ≤1.0 IU/L increase in s-LH from 0 to 2 h after 1st \& 2nd injection.% changes in PSA throughout treatment.% of 60 pts with s-testosterone levels \>1.735 nmol/L after 2nd injection.Testosterone PD and triptorelin PK metrics in 15 pts
Outcome measures
Outcome data not reported
Adverse Events
Triptorelin
Serious events: 17 serious events
Other events: 115 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Triptorelin
n=120 participants at risk
Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.83%
1/120 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
0.83%
1/120 • Number of events 1
|
|
Cardiac disorders
Atrial flutter
|
0.83%
1/120 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.83%
1/120 • Number of events 1
|
|
Endocrine disorders
Diabetes mellitus
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.83%
1/120 • Number of events 1
|
|
Injury, poisoning and procedural complications
skin laceration
|
0.83%
1/120 • Number of events 1
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.83%
1/120 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.83%
1/120 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penis carcinoma
|
0.83%
1/120 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.7%
2/120 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
Diabetic neuropathy
|
0.83%
1/120 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.83%
1/120 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.83%
1/120 • Number of events 1
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.83%
1/120 • Number of events 1
|
Other adverse events
| Measure |
Triptorelin
n=120 participants at risk
Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
|
|---|---|
|
General disorders
Oedema peripheral
|
5.0%
6/120 • Number of events 6
|
|
Infections and infestations
Bronchitis
|
5.0%
6/120 • Number of events 7
|
|
Infections and infestations
Influenza
|
15.8%
19/120 • Number of events 24
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
9/120 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.8%
13/120 • Number of events 17
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
9/120 • Number of events 12
|
|
Nervous system disorders
Headache
|
7.5%
9/120 • Number of events 9
|
|
Psychiatric disorders
Insomnia
|
5.0%
6/120 • Number of events 7
|
|
Renal and urinary disorders
Urinary retention
|
5.0%
6/120 • Number of events 10
|
|
Renal and urinary disorders
Urinary tract infection
|
9.2%
11/120 • Number of events 14
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
10.0%
12/120 • Number of events 12
|
|
Reproductive system and breast disorders
Testicular atrophy
|
7.5%
9/120 • Number of events 9
|
|
Vascular disorders
Hot flush
|
72.5%
87/120 • Number of events 98
|
|
Vascular disorders
Hypertension
|
14.2%
17/120 • Number of events 18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication or scientific communication related to this study can only take place once the agreement between the Sponsor and the Investigator has been reached.
- Publication restrictions are in place
Restriction type: OTHER