The aim of the study is to determine if triptorelin formulated for use every 6 months (given twice during the study) is effective and safe for when given by injection under the skin for the treatment of adult males with cancer in the prostate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
147
A prolonged release formulation of triptorelin pamoate 22.5 mg 6-month formulation in D, L-lactide-co-glycolide polymers for single subcutaneous injection on Day 1 and Day 169
Percentage of Participants Who Maintained Castrate Levels of Serum Testosterone During the Study
Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Maintenance of castration during the study was defined as testosterone \<1.735 nanomoles per liter (nmol/L) (\<50 nanograms/deciliter \[ng/dL\]) at Days 29, 85, 141, 169, 253, 309 and 337.
Time frame: Up to Day 337
Percentage of Participants Castrated on Days 29, 85, 141, 169, 253, 309 and 337
Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Castration was defined as testosterone \<1.735 nmol/L (\<50 ng/dL).
Time frame: Days 29, 85, 141, 169, 253, 309 and 337
Percentage of Participants With a Serum Testosterone Level <0.694 Nmol/L (<20 ng/dL) During the Study
Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method.
Time frame: Up to Day 337
Percentage of Participants With a Serum Testosterone Level <0.694 Nmol/L (<20 ng/dL) on Days 29, 85, 141, 169, 253, 309 and 337
Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method.
Time frame: Days 29, 85, 141, 169, 253, 309 and 337
Percentage of Participants Castrated on Days 3 and 7 After Each Injection Administered on Days 1 and 169
Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Castration was defined as testosterone \<1.735 nmol/L (\<50 ng/dL).
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Cliniques Universitaires Saint-Luc
Brussels, Belgium
UZ Antwerpen
Edegem, Belgium
AZGroeninge
Kortrijk, Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman - Urologie
Liège, Belgium
Fakultni nemocnice u sv. Anny v Brne
Brno, Czechia
Fakultni nemocnice Olomouc
Olomouc, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, Czechia
Centre Hospitalier Universitaire D'Angers - Urologie
Angers, France
CHU Brest-Hopital Morvan Institut de Cancerologie et d'Hemat
Brest, France
Clinique Pasteur-Lanroze - Oncology
Brest, France
...and 29 more locations
Time frame: On Days 3, 7, 171, and 175
Percent Change From Baseline in Prostate Specific Antigen (PSA) at Days 169 and 337
Blood samples were collected for the measurement of plasma PSA concentrations. Percent change in PSA was defined as the absolute value of the difference between the PSA values at Days 169 and 337 and the baseline value divided by the baseline value. The baseline value was the last sample prior to the first injection.
Time frame: Baseline (prior to injection on Day 1), Days 169 and 337
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs of Local Intolerance
An adverse event (AE) was any untoward medical occurrence in clinical study participant, temporally associated with use of study treatment, whether or not considered related to study treatment. TEAEs were AEs that started or worsened on or after the first study treatment administration and within 168 days after the last dose of study treatment, or up to Day 337, whichever was later. Local tolerance was assessed 2 hours after each injection by examination of injection site for signs such as but not limited to tenderness, redness, bruising, erythema, swelling, rash, pain, itching, induration, hematoma, ulceration or necrosis.
Time frame: From first dose of study treatment (Day 1) up to end of study visit (Day 337)