Trial Outcomes & Findings for Effects of Triptorelin When Given Every 6-months Under the Skin to Adult Males With Cancer in the Prostate (NCT NCT05458856)
NCT ID: NCT05458856
Last Updated: 2025-07-25
Results Overview
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.
COMPLETED
PHASE3
147 participants
Up to Day 337
2025-07-25
Participant Flow
This Phase III, multicenter, open-label, single arm study was conducted at 26 investigational sites in 6 countries from 30-Aug-2022 to 08-Jul-2024 in participants with locally advanced and/or metastatic prostate cancer previously treated and castrated with a gonadotropin-releasing hormone (GnRH) analogue.
The study consisted of a screening period (Day -28 to Day -1), study treatment administration on Days 1 and 169 (with visits on Days 3, 7, 29, 85, 141, 171, 175, 253, 309) and an end of study/early discontinuation visit on Day 337. A total of 147 participants were enrolled in the study.
Participant milestones
| Measure |
Triptorelin Embonate 22.5 mg
Participants received triptorelin embonate 22.5 milligrams (mg) subcutaneous (SC) injection on Days 1 and 169.
|
|---|---|
|
Overall Study
STARTED
|
147
|
|
Overall Study
Received Treatment
|
145
|
|
Overall Study
COMPLETED
|
134
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Triptorelin Embonate 22.5 mg
Participants received triptorelin embonate 22.5 milligrams (mg) subcutaneous (SC) injection on Days 1 and 169.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Death
|
4
|
|
Overall Study
Protocol Deviation
|
3
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Effects of Triptorelin When Given Every 6-months Under the Skin to Adult Males With Cancer in the Prostate
Baseline characteristics by cohort
| Measure |
Triptorelin Embonate 22.5 mg
n=147 Participants
Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.
|
|---|---|
|
Age, Continuous
|
71.8 years
STANDARD_DEVIATION 8.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
109 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 337Population: The full analysis set (FAS) included all participants who signed an informed consent form (ICF) and received 2 administrations of study treatment and completed all visits for testosterone measurement (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. 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.
Outcome measures
| Measure |
Triptorelin Embonate 22.5 mg
n=120 Participants
Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.
|
|---|---|
|
Percentage of Participants Who Maintained Castrate Levels of Serum Testosterone During the Study
|
95.0 percentage of participants
Interval 89.4 to 98.1
|
SECONDARY outcome
Timeframe: Days 29, 85, 141, 169, 253, 309 and 337Population: The FAS included all participants who signed an ICF and received 2 administrations of study treatment and completed all visits for testosterone measurement (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).
Outcome measures
| Measure |
Triptorelin Embonate 22.5 mg
n=120 Participants
Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.
|
|---|---|
|
Percentage of Participants Castrated on Days 29, 85, 141, 169, 253, 309 and 337
Day 29
|
100.0 percentage of participants
Interval 97.0 to 100.0
|
|
Percentage of Participants Castrated on Days 29, 85, 141, 169, 253, 309 and 337
Day 85
|
100.0 percentage of participants
Interval 97.0 to 100.0
|
|
Percentage of Participants Castrated on Days 29, 85, 141, 169, 253, 309 and 337
Day 141
|
98.3 percentage of participants
Interval 94.1 to 99.8
|
|
Percentage of Participants Castrated on Days 29, 85, 141, 169, 253, 309 and 337
Day 169
|
97.5 percentage of participants
Interval 92.9 to 99.5
|
|
Percentage of Participants Castrated on Days 29, 85, 141, 169, 253, 309 and 337
Day 253
|
100.0 percentage of participants
Interval 97.0 to 100.0
|
|
Percentage of Participants Castrated on Days 29, 85, 141, 169, 253, 309 and 337
Day 309
|
99.2 percentage of participants
Interval 95.4 to 100.0
|
|
Percentage of Participants Castrated on Days 29, 85, 141, 169, 253, 309 and 337
Day 337
|
99.2 percentage of participants
Interval 95.4 to 100.0
|
SECONDARY outcome
Timeframe: Up to Day 337Population: The FAS included all participants who signed an ICF and received 2 administrations of study treatment and completed all visits for testosterone measurement (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.
Outcome measures
| Measure |
Triptorelin Embonate 22.5 mg
n=120 Participants
Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.
|
|---|---|
|
Percentage of Participants With a Serum Testosterone Level <0.694 Nmol/L (<20 ng/dL) During the Study
|
83.3 percentage of participants
Interval 75.4 to 89.5
|
SECONDARY outcome
Timeframe: Days 29, 85, 141, 169, 253, 309 and 337Population: The FAS included all participants who signed an ICF and received 2 administrations of study treatment and completed all visits for testosterone measurement (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.
Outcome measures
| Measure |
Triptorelin Embonate 22.5 mg
n=120 Participants
Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.
|
|---|---|
|
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
Day 85
|
92.5 percentage of participants
Interval 86.2 to 96.5
|
|
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
Day 141
|
92.5 percentage of participants
Interval 86.2 to 96.5
|
|
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
Day 29
|
92.5 percentage of participants
Interval 86.2 to 96.5
|
|
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
Day 169
|
94.2 percentage of participants
Interval 88.4 to 97.6
|
|
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
Day 253
|
95.8 percentage of participants
Interval 90.5 to 98.6
|
|
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
Day 309
|
95.8 percentage of participants
Interval 90.5 to 98.6
|
|
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
Day 337
|
98.3 percentage of participants
Interval 94.1 to 99.8
|
SECONDARY outcome
Timeframe: On Days 3, 7, 171, and 175Population: The FAS included all participants who signed an ICF and received 2 administrations of study treatment and completed all visits for testosterone measurement (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).
Outcome measures
| Measure |
Triptorelin Embonate 22.5 mg
n=120 Participants
Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.
|
|---|---|
|
Percentage of Participants Castrated on Days 3 and 7 After Each Injection Administered on Days 1 and 169
Day 3
|
92.5 percentage of participants
Interval 86.2 to 96.5
|
|
Percentage of Participants Castrated on Days 3 and 7 After Each Injection Administered on Days 1 and 169
Day 7
|
98.3 percentage of participants
Interval 94.1 to 99.8
|
|
Percentage of Participants Castrated on Days 3 and 7 After Each Injection Administered on Days 1 and 169
Day 171
|
95.0 percentage of participants
Interval 89.4 to 98.1
|
|
Percentage of Participants Castrated on Days 3 and 7 After Each Injection Administered on Days 1 and 169
Day 175
|
95.8 percentage of participants
Interval 90.5 to 98.6
|
SECONDARY outcome
Timeframe: Baseline (prior to injection on Day 1), Days 169 and 337Population: The FAS included all participants who signed an ICF and received 2 administrations of study treatment and completed all visits for testosterone measurement (Days 29, 85, 141, 169, 253, 309 and 337). Only those participants with data collected at specified timepoints are reported.
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.
Outcome measures
| Measure |
Triptorelin Embonate 22.5 mg
n=118 Participants
Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.
|
|---|---|
|
Percent Change From Baseline in Prostate Specific Antigen (PSA) at Days 169 and 337
Day 169
|
0.00 percent change
Interval -35.6 to 0.0
|
|
Percent Change From Baseline in Prostate Specific Antigen (PSA) at Days 169 and 337
Day 337
|
0.00 percent change
Interval -46.9 to 14.3
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to end of study visit (Day 337)Population: The safety set included all participants who received at least 1 dose of study treatment.
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.
Outcome measures
| Measure |
Triptorelin Embonate 22.5 mg
n=145 Participants
Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs of Local Intolerance
TEAEs
|
88 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs of Local Intolerance
TEAEs of Local Intolerance
|
19 Participants
|
Adverse Events
Triptorelin Embonate 22.5 mg
Serious adverse events
| Measure |
Triptorelin Embonate 22.5 mg
n=145 participants at risk
Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.
|
|---|---|
|
Infections and infestations
COVID-19
|
2.8%
4/145 • Number of events 4 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Anal abscess
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Appendicitis
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Lyme disease
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Peroneal nerve injury
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Disease progression
|
1.4%
2/145 • Number of events 2 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Death
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
General physical health deterioration
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
1.4%
2/145 • Number of events 2 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Cerebral haematoma
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.69%
1/145 • Number of events 1 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Triptorelin Embonate 22.5 mg
n=145 participants at risk
Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.
|
|---|---|
|
Vascular disorders
Hot flush
|
11.7%
17/145 • Number of events 18 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
9.7%
14/145 • Number of events 15 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
9/145 • Number of events 9 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
5.5%
8/145 • Number of events 8 • Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
The safety set included all participants who received at least 1 dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place