Prostatic Neoplasm
Conditions
Keywords
triptorelin, 6-month formulation, advanced prostate cancer
Brief summary
Efficacy and safety of a triptorelin 6-month formulation in patients with advanced prostate cancer. It was assumed that during the study treatment \>90% of the patients would achieve and maintain castrate levels of serum testosterone.
Detailed description
Efficacy of triptorelin treatment on gonadotropin (LH) stimulation from hypophysis, as well as on the PSA (prostate specific antigen) levels and safety laboratory parameters. The triptorelin pharmacokinetics and testosterone pharmacodynamics were assessed in a subset of 15 patients.
Interventions
DRUGtriptorelin embonate (INN)
Triptorelin embonate 22.5 mg 6 month formulation to be injected every 24 weeks
Sponsors
Debiopharm International SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically proven prostate cancer. * The prostate cancer should be staged T3-4NxMx or TxN1-3Mx or TxNxM1 according to the TNM classification or the patient should have rising PSA after failed local therapy and be candidate for androgen deprivation therapy. * Serum testosterone levels \>5 nmol/L. * Karnofsky performance index \>40. * Expected survival \> 18 months. * Absence of another malignancy, other than local dermatological, for the previous 5 years. * Signed informed consent before entry into the study.
Exclusion criteria
* Prior hormonal treatment for prostate cancer within 6 months prior to study start. * Use of finasteride (Proscar®) or dutasteride (Avodart®/Avolve®) within 2 months prior to study start. * Presence of another neoplastic lesion or brain metastases. * Prior hypophysectomy or adrenalectomy. * Known or suspicion of vertebral metastases with risk of spinal compression. * Severe kidney or liver failure (creatinine \> 2 times the upper normal limit, ASAT and ALAT \>3 times the upper normal limit). * Any concomitant disorder or resulting therapy that is likely to interfere with patient compliance or with the study in the opinion of the Investigator. * Participation in another study with an experimental drug within 3 months before study start or within 5 drug half-lives of the investigational drug (whichever is the longer). * Known hypersensitivity to any of the test materials or related compounds. * Known active use of recreational drug or alcohol dependence in the opinion of the Investigator. * Any current use or use within 6 months prior to treatment start of medications which are known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole, aminoglutethimide, oestrogens, and progesterone. * Use of systemic or inhaled corticosteroids (topical application permitted). * Use of anticoagulants: heparin and coumarine derivatives (acetylsalicylic acid permitted). * Inability to give Informed Consent or to comply fully with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of Castration and Maintenance of Castration | at Day 29 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LH Increase | 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 |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Triptorelin Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Triptorelin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 120 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 71.11 years STANDARD_DEVIATION 8.46 |
| Region of Enrollment South Africa | 120 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 115 / 120 |
| serious Total, serious adverse events | 17 / 120 |
Outcome results
Primary
Achievement of Castration and Maintenance of Castration
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).
Time frame: at Day 29
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Triptorelin | Achievement of Castration and Maintenance of Castration | 97.5 percentage of enrolled patients |
Secondary
LH Increase
% 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
Time frame: day 1 and day 169