Prostate Cancer
Conditions
Brief summary
The aim of the study is to compare in an exploratory fashion the efficacy on progression-free survival of lanreotide in addition to non steroidal anti androgens and LHRH-a in non metastatic castrate resistant prostate cancer patients.
Detailed description
LHRH-a=Luteinizing Hormone-Releasing Hormone Analogues
Interventions
DRUGLanreotide, non steroidal anti androgens and LHRH-a
Lanreotide 120 mg. Injection every 28 days, to be administered till progression or for a maximum of 24 months. Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression.
DRUGNon steroidal anti androgens and LHRH-a
Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven diagnosis of prostate cancer * Evidence of PSA progression despite castrate levels of testosterone (\<50 ng/dL) following orchiectomy or during therapy with luteinizing hormone releasing hormone agonists (LHRH-a) * Patients with non-metastatic or stable metastatic disease * Chromogranin A elevation above normal range (confirmed by a second evaluation at least 1 week later) \[cut off levels will be \> 20 U/L for enzyme linked immunosorbent (ELISA) assay and \> 100 ng/ml for immunoradiometric (IRMA) assay\]
Exclusion criteria
* Patients who according to the investigator opinion are candidates to be treated immediately with chemotherapy (e.g. docetaxel) * First line treatment with antiandrogen in monotherapy * Visceral metastasis * Previous or concomitant treatment with a somatostatin analogue
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival | Week 96 |
Secondary
| Measure | Time frame |
|---|---|
| Prostate Specific Antigen (PSA) Response | Week 96 |
| Median Time to PSA Response | Week 96 |
| Reduction in Chromogranin A Serum Levels | Baseline, Week 96 |
Countries
Italy
Participant flow
Recruitment details
Subjects ≥18 years meeting inclusion criteria were recruited for this study.
Pre-assignment details
Investigators screened 8 subjects. Randomised 3 subjects and 5 were not randomised.
Participants by arm
| Arm | Count |
|---|---|
| Arm A: Non-steroidal Anti Androgens + LHRH-a Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression. | 2 |
| Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a 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. | 1 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | INCLUSION CRITERIA 4 NOT RESPECTED | 1 | 0 |
| Overall Study | Screening Chromogranin A-in normal range | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Arm A: Non-steroidal Anti Androgens + LHRH-a | Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a | Total |
|---|---|---|---|
| Age, Continuous | 72.50 years | 57.00 years | 61.00 years |
| Age, Customized >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Customized Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment Italy | 2 participants | 1 participants | 3 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 1 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
Progression-free Survival
Time frame: Week 96
Population: Study early terminated due to poor enrollment.
Secondary
Median Time to PSA Response
Time frame: Week 96
Population: Study early terminated due to poor enrollment
Secondary
Prostate Specific Antigen (PSA) Response
Time frame: Week 96
Population: Study early terminated due to poor enrollment
Secondary
Reduction in Chromogranin A Serum Levels
Time frame: Baseline, Week 96
Population: Study early terminated due to poor enrollment