Phase 2
Completed N=103
Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg
Source: ClinicalTrials.gov NCT01257425 ↗Enrolled (actual)
103
Serious AEs
17.5%
Results posted
May 2014
Primary outcomePrimary: Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d). — 4.24; 4.23 log(ng*day/mL)
Summary
The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve [AUC1-85day] for serum testosterone in patients with advanced prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d). |
4.24; 4.23 | — |
| SECONDARY Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d) |
4.49; 4.52 | — |
| SECONDARY Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d) |
2.80; 2.88 | — |
| SECONDARY Maximum Concentration of Serum Testosterone [Cmax] - Raw Data |
5.74; 5.50 | — |
| SECONDARY Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data |
1.67; 1.62 | 0.85 |
| SECONDARY Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL |
22.0; 22.0 | 0.98 |
| SECONDARY Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL |
22.0; 22.0 | 0.84 |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically proven prostate cancer, locally advanced or metastatic, or rising PSA (prostate-specific antigen) after failed local therapy, and the patient scheduled to receive androgen deprivation therapy
- Serum testosterone levels ≥ 125 ng/dl (1.25 ng/ml, 1.25 microg/l, 4.3 nmol/l) measured by any laboratory or on site within the previous 6 months or at study start
- Karnofsky performance index > 70
- Expected survival ≥ 9 months
Exclusion Criteria
- Prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone (GnRH) agonists or antagonists within the last 12 months preceding the study or concomitant treatment with one or more of these substance(s)
- Any current use or 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
- Patient at risk of spinal cord compression or ureter obstruction
- Prior hypophysectomy or adrenalectomy
Data sourced from ClinicalTrials.gov (NCT01257425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.