Trial Outcomes & Findings for Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients (NCT NCT01313273)
NCT ID: NCT01313273
Last Updated: 2019-11-22
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
3 participants
Primary outcome timeframe
Week 96
Results posted on
2019-11-22
Participant Flow
Subjects ≥18 years meeting inclusion criteria were recruited for this study.
Investigators screened 8 subjects. Randomised 3 subjects and 5 were not randomised.
Participant milestones
| Measure |
Arm A: Non-steroidal Anti Androgens + LHRH-a
Non-steroidal anti androgens (e.g. bicalutamide 50 mg/day) plus Luteinizing Hormone-Releasing Hormone Analogues (LHRH-a) (e.g. triptorelin 3.75 mg/month) till progression.
|
Arm B: Lanreotide + Non Steroidal Anti Androgens and LHRH-a
Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non steroidal anti androgens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Arm A: Non-steroidal Anti Androgens + LHRH-a
Non-steroidal anti androgens (e.g. bicalutamide 50 mg/day) plus Luteinizing Hormone-Releasing Hormone Analogues (LHRH-a) (e.g. triptorelin 3.75 mg/month) till progression.
|
Arm B: Lanreotide + Non Steroidal Anti Androgens and LHRH-a
Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non steroidal anti androgens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
|
|---|---|---|
|
Overall Study
INCLUSION CRITERIA 4 NOT RESPECTED
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Screening Chromogranin A-in normal range
|
0
|
1
|
Baseline Characteristics
Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients
Baseline characteristics by cohort
| Measure |
Arm A: Non-steroidal Anti Androgens + LHRH-a
n=2 Participants
Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
|
Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a
n=1 Participants
Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.50 years
n=99 Participants
|
57.00 years
n=107 Participants
|
61.00 years
n=206 Participants
|
|
Age, Customized
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Customized
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 96Population: Study early terminated due to poor enrollment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 96Population: Study early terminated due to poor enrollment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 96Population: Study early terminated due to poor enrollment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 96Population: Study early terminated due to poor enrollment
Outcome measures
Outcome data not reported
Adverse Events
Arm A: Non-steroidal Anti Androgens + LHRH-a
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A: Non-steroidal Anti Androgens + LHRH-a
n=2 participants at risk
Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
|
Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a
n=1 participants at risk
Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • AEs were reported from Baseline (visit 2) to visit 10 (week 96 - End of study)
All Adverse Events (AEs) documented for this study were treatment emergent. Overall, for 1 patient (100.0%) of Arm B at least one AE, at least one AE related to study treatment and at least one severe AE were reported.
|
100.0%
1/1 • Number of events 3 • AEs were reported from Baseline (visit 2) to visit 10 (week 96 - End of study)
All Adverse Events (AEs) documented for this study were treatment emergent. Overall, for 1 patient (100.0%) of Arm B at least one AE, at least one AE related to study treatment and at least one severe AE were reported.
|
|
Investigations
Transaminases increased
|
0.00%
0/2 • AEs were reported from Baseline (visit 2) to visit 10 (week 96 - End of study)
All Adverse Events (AEs) documented for this study were treatment emergent. Overall, for 1 patient (100.0%) of Arm B at least one AE, at least one AE related to study treatment and at least one severe AE were reported.
|
100.0%
1/1 • Number of events 1 • AEs were reported from Baseline (visit 2) to visit 10 (week 96 - End of study)
All Adverse Events (AEs) documented for this study were treatment emergent. Overall, for 1 patient (100.0%) of Arm B at least one AE, at least one AE related to study treatment and at least one severe AE were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place