Induction and Maintenance of Castration After Subcutaneous Injections of Triptorelin Pamoate in Patients With Prostate Cancer (DKP 3M SC)
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase III Single Arm Study to Evaluate the Efficacy, Safety and Local Tolerability of a Subcutaneous 3-month Formulation of Triptorelin Pamoate (11.25 mg) in Patients With Locally Advanced or Metastatic Prostate Cancer|
- Percentage of Subjects Demonstrating Castration at Day 29 and Maintaining Castration at Day 183 [ Time Frame: At Day 29 and 183 ]Percentage of subjects castrated (i.e. with serum testosterone <50 ng/dL or 1.735 nmol/L, using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and the proportion with castration maintained at Day 183 (after receiving 2 S.C. administrations of triptorelin pamoate, three months apart); they were calculated along with their respective 95% confidence intervals (CI) using exact methods on the ITT population at Day 29 and on the initially castrated (IC) population at Day 183
- Percentage of Subjects Demonstrating Castration Before Administration of the Second Dose [ Time Frame: At Day 92 ]Percentage of subjects demonstrating castration at Day 92 (before administration of the second dose) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.
- Probability of Testosterone <50 ng/dL [ Time Frame: Day 29 through Day 183 ]
Probability of testosterone <50 ng/dL from Day 29 to Day 183 was assessed as a secondary endpoint using the time to event from first administration date to first observed (and subsequently confirmed if assessment not performed at end of study or early withdrawal visits) serum testosterone level ≥50 ng/dL or ≥1.735 nmol/L at or after Day 29, assessed using the LC-MS/MS Method and Missing Data imputed by immunoassay method Kaplan-Meier Analysis.
LC-MS/MS: Liquid Chromatography-Tandem Mass Spectrometry
- Percentage of Subjects Demonstrating Castration With Testosterone Level <50 ng/dL at Day 95 [ Time Frame: Day 95 ]Percentage of subjects demonstrating castration at Day 95 (3-4 days after administration of the second dose to assess the suppression of acute-on-chronic effect following the second administration) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.
- Time to Achieve Castration (Tcast) [ Time Frame: Up to Day 36 ]Time to castration (Tcast) from first administration date until first observed serum testosterone level <50 ng/dL or <1.735 nmol/L evaluated using the immunoassay method only (i.e. defined as the number of days between the injection time at Day 1 and castration achievement)
- Plasma Triptorelin Levels (Cmin) [ Time Frame: At Day 92 and 183 ]Minimal triptorelin plasma concentration at the end of each dosage interval just before the next dose injection (Cmin) for Days 92 and 183 were assessed.
- Percentage Change in Prostate Specific Antigen (PSA) Levels From Baseline in All Subjects [ Time Frame: From Day 1 (Baseline) to Day 183 (End of study) ]Serum PSA level was presented throughout the study using descriptive statistics displaying raw values, change from Baseline and percentage change from Baseline at each visit in all subjects from the ITT population only. Additionally, the PSA level was described in subjects with elevated PSA levels (i.e. >4 ng/mL) at study entry, and the proportion of subjects with normal PSA levels (i.e. [0-4] ng/mL) at Day 183 compared to Baseline was presented.
- Percentage of Subjects With Normal and Abnormal PSA Levels at Day 183 (End of Study Visit) [ Time Frame: At Day 183 ]
0-4 ng/mL (normal PSA value)
>4 ng/mL (abnormal PSA levels)
- Clinically Apparent Tumor Progression [ Time Frame: Day 92 and 183 ]Tumour progression was recorded according to the Investigator's clinical judgement, considering the PSA levels and any other indications of disease; the clinical confirmation might be supplemented by radiological or other investigations or scans if required. The lack of clinically apparent tumour progression was assessed at Day 92 (prior to administration of the second dose) and Day 183 (end of study visit).
- Percentage of Subjects With Adverse Events [ Time Frame: Up to Day 183 ]
- Time to Cmax (Tmax) of Triptorelin [ Time Frame: At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1 ]
- Peak Plasma Concentration Value (Cmax) of Triptorelin [ Time Frame: At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1 ]
- Area Under the Concentration Versus Time Curve Between 0 and 24 Hours (AUC0-24) of Triptorelin [ Time Frame: At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1 ]
- Cmin of Triptorelin in Subset of 18 Subjects [ Time Frame: At Day 92 and 183 ]
|Study Start Date:||January 2013|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
11.25mg, SC on Day 1 and Day 92
|Drug: Triptorelin Pamoate 11.25mg|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715129
|Study Director:||Medical Director, Uro-Oncology||Ipsen|