Trial Outcomes & Findings for Effect of Triptorelin (Decapeptyl®) 22.5 mg on Two Biomarkers in Patients With Advanced Prostate Cancer (NCT NCT01020448)
NCT ID: NCT01020448
Last Updated: 2019-01-30
Results Overview
PCA-3 score = (mRNA PCA3/mRNA PSA)x1000 * Non-assessable = Associated PSA mRNA \<7500 copies/mL * ≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA \>7500 copies/mL * \<35 = PCA-3 mRNA above BLQ and less than 35 * ≥35 = PCA-3 mRNA greater or equal to 35
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
339 participants
Primary outcome timeframe
At month 6 post-treatment
Results posted on
2019-01-30
Participant Flow
Study Initiation Date: 30-Nov-2009. Subjects screened were 339 and screen failures were 13.
Participant milestones
| Measure |
Triptorelin (Decapeptyl®) 22.5 mg
Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
|
|---|---|
|
Pre-assignment
STARTED
|
339
|
|
Pre-assignment
COMPLETED
|
326
|
|
Pre-assignment
NOT COMPLETED
|
13
|
|
Treatment
STARTED
|
325
|
|
Treatment
COMPLETED
|
299
|
|
Treatment
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
Triptorelin (Decapeptyl®) 22.5 mg
Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
|
|---|---|
|
Pre-assignment
Adverse Event
|
6
|
|
Pre-assignment
Withdrawal by Subject
|
5
|
|
Pre-assignment
Does Not Meet Entry Criteria
|
2
|
|
Treatment
Adverse Event
|
11
|
|
Treatment
Consent Withdrawn
|
3
|
|
Treatment
Disease Progression
|
2
|
|
Treatment
Lack of Efficacy
|
8
|
|
Treatment
Lost to Follow-up
|
2
|
Baseline Characteristics
Effect of Triptorelin (Decapeptyl®) 22.5 mg on Two Biomarkers in Patients With Advanced Prostate Cancer
Baseline characteristics by cohort
| Measure |
Triptorelin (Decapeptyl®) 22.5 mg
n=325 Participants
Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
|
|---|---|
|
Age, Continuous
|
72.6 years
STANDARD_DEVIATION 8.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
325 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
307 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=99 Participants
|
|
Height
|
172.3 Cm
STANDARD_DEVIATION 6.5 • n=99 Participants
|
|
Weight
|
79.6 KG
STANDARD_DEVIATION 13.4 • n=99 Participants
|
|
BMI
|
26.79 kg/m²
STANDARD_DEVIATION 4.23 • n=99 Participants
|
|
PCA-3 Score
Non-assessable
|
39 participants
n=99 Participants
|
|
PCA-3 Score
≤BLQ
|
15 participants
n=99 Participants
|
|
PCA-3 Score
<35
|
89 participants
n=99 Participants
|
|
PCA-3 Score
≥35
|
179 participants
n=99 Participants
|
|
PCA-3 Score
Missing - No sample analysis done
|
3 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At month 6 post-treatmentPopulation: Number of participants analyzed were 298 as one participant was admitted to an asylum and was withdrawn before month 1 visit was scheduled. No post-baseline assessment was available for this patient.
PCA-3 score = (mRNA PCA3/mRNA PSA)x1000 * Non-assessable = Associated PSA mRNA \<7500 copies/mL * ≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA \>7500 copies/mL * \<35 = PCA-3 mRNA above BLQ and less than 35 * ≥35 = PCA-3 mRNA greater or equal to 35
Outcome measures
| Measure |
Triptorelin (Decapeptyl®) 22.5 mg
n=298 Participants
Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
|
|---|---|
|
PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA
≥35
|
24 participants
|
|
PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA
Missing - No sample analysis done
|
5 participants
|
|
PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA
Non-assessable
|
232 participants
|
|
PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA
≤BLQ
|
27 participants
|
|
PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA
<35
|
10 participants
|
SECONDARY outcome
Timeframe: At month 1 and 3 post-treatmentPopulation: Analysis based on number (N) of patients with a valid value. Intention-to-treat (ITT) population.
PCA-3 score = (mRNA PCA3/mRNA PSA)x1000 * Non-assessable = Associated PSA mRNA \<7500 copies/mL * ≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA \>7500 copies/mL * \<35 = PCA-3 mRNA above BLQ and less than 35 * ≥35 = PCA-3 mRNA greater or equal to 35
Outcome measures
| Measure |
Triptorelin (Decapeptyl®) 22.5 mg
n=322 Participants
Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
|
|---|---|
|
PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA
Month 3: Non-assessable (N=313)
|
215 participants
|
|
PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA
Month 3: ≤BLQ (N=313)
|
31 participants
|
|
PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA
Month 3: <35 (N=313)
|
34 participants
|
|
PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA
Month 3: ≥35 (N=313)
|
31 participants
|
|
PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA
Month 3: Missing - No sample analysis done (N=313)
|
2 participants
|
|
PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA
Month 1: Non-assessable (N=322)
|
109 participants
|
|
PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA
Month 1: ≤BLQ (N=322)
|
40 participants
|
|
PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA
Month 1: <35 (N=322)
|
80 participants
|
|
PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA
Month 1: ≥35 (N=322)
|
91 participants
|
|
PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA
Month 1: Missing - No sample analysis done (N=322)
|
2 participants
|
SECONDARY outcome
Timeframe: At baseline, month 1, 3 and 6 post-treatmentPopulation: Analysis based on number (N) of patients with a valid value. ITT population.
TMPRSS2-ERG = (TMPRSS2-ERG mRNA / PSA mRNA) x 100000 A TMPRSS2-ERG score \<35 was described as 'negative' and a TMPRSS2-ERG score ≥35 as 'positive.'
Outcome measures
| Measure |
Triptorelin (Decapeptyl®) 22.5 mg
n=322 Participants
Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
|
|---|---|
|
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
Baseline: Non-assessable (N=322)
|
33 participants
|
|
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
Baseline: <35 negative (N=322)
|
140 participants
|
|
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
Baseline: ≥35 positive (N=322)
|
149 participants
|
|
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
Month 1: Non-assessable (N=322)
|
117 participants
|
|
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
Month 1: <35 negative (N=322)
|
97 participants
|
|
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
Month 1: ≥35 positive (N=322)
|
106 participants
|
|
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
Month 1: Missing - No sample analysis done (N=322)
|
2 participants
|
|
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
Month 3: Non-assessable (N=313)
|
213 participants
|
|
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
Month 3: <35 negative (N=313)
|
45 participants
|
|
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
Month 3: ≥35 positive (N=313)
|
53 participants
|
|
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
Month 3: Missing - No sample analysis done (N=313)
|
2 participants
|
|
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
Month 6: Non-assessable (N=298)
|
241 participants
|
|
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
Month 6: <35 negative (N=298)
|
24 participants
|
|
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
Month 6: ≥35 positive (N=298)
|
27 participants
|
|
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
Month 6: Missing - No sample analysis done (N=298)
|
6 participants
|
SECONDARY outcome
Timeframe: At month 1, 3 and 6 post-treatmentPopulation: Analysis based on number (N) of patients with a valid value. ITT population.
Outcome measures
| Measure |
Triptorelin (Decapeptyl®) 22.5 mg
n=322 Participants
Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
|
|---|---|
|
Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL)
Month 6 (N=298)
|
90.9 percentage of participants
|
|
Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL)
Month 1 (N=322)
|
94.7 percentage of participants
|
|
Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL)
Month 3 (N=313)
|
95.2 percentage of participants
|
SECONDARY outcome
Timeframe: At baseline, month 1, 3 and 6 post-treatmentPopulation: Analysis based on number (N) of patients with a valid value. ITT population.
Outcome measures
| Measure |
Triptorelin (Decapeptyl®) 22.5 mg
n=322 Participants
Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
|
|---|---|
|
PSA Level
Baseline (N=321)
|
45.4 μg/L
Interval 1.0 to 12239.0
|
|
PSA Level
Month 1 (N=320)
|
8.3 μg/L
Interval 0.0 to 581.0
|
|
PSA Level
Month 3 (N=311)
|
1.8 μg/L
Interval 0.0 to 969.0
|
|
PSA Level
Month 6 (N=296)
|
1.2 μg/L
Interval 0.0 to 1251.0
|
SECONDARY outcome
Timeframe: For the duration of the study (up to month 6)Outcome measures
| Measure |
Triptorelin (Decapeptyl®) 22.5 mg
n=325 Participants
Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
|
|---|---|
|
Safety, Assessed Through the Collection of Adverse Events (AEs)
Any Adverse Events (AEs)
|
193 participants
|
|
Safety, Assessed Through the Collection of Adverse Events (AEs)
Any Treatment Emergent Adverse Events (TEAEs)
|
190 participants
|
|
Safety, Assessed Through the Collection of Adverse Events (AEs)
TEAEs Leading to Withdrawal
|
11 participants
|
|
Safety, Assessed Through the Collection of Adverse Events (AEs)
TEAEs Leading to Death
|
11 participants
|
|
Safety, Assessed Through the Collection of Adverse Events (AEs)
Serious Adverse Events (SAEs)
|
37 participants
|
Adverse Events
Triptorelin (Decapeptyl®) 22.5 mg
Serious events: 37 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Triptorelin (Decapeptyl®) 22.5 mg
n=325 participants at risk
Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
|
|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.62%
2/325 • Up to month 6
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.31%
1/325 • Up to month 6
|
|
Cardiac disorders
Heart failure
|
0.62%
2/325 • Up to month 6
|
|
Cardiac disorders
Chronic heart failure
|
0.31%
1/325 • Up to month 6
|
|
Gastrointestinal disorders
Perforated colon
|
0.31%
1/325 • Up to month 6
|
|
Gastrointestinal disorders
Perforated gall bladder
|
0.31%
1/325 • Up to month 6
|
|
Gastrointestinal disorders
Fecal peritonitis
|
0.31%
1/325 • Up to month 6
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.31%
1/325 • Up to month 6
|
|
Hepatobiliary disorders
Liver failure
|
0.31%
1/325 • Up to month 6
|
|
Renal and urinary disorders
Renal failure
|
0.62%
2/325 • Up to month 6
|
|
Infections and infestations
Septicaemia
|
0.31%
1/325 • Up to month 6
|
|
Psychiatric disorders
Suicide
|
0.31%
1/325 • Up to month 6
|
|
Gastrointestinal disorders
Subileus
|
0.31%
1/325 • Up to month 6
|
|
Infections and infestations
Urosepsis
|
0.31%
1/325 • Up to month 6
|
|
Infections and infestations
Bronchitis
|
0.31%
1/325 • Up to month 6
|
|
Musculoskeletal and connective tissue disorders
Worsening of chronic lumbago
|
0.31%
1/325 • Up to month 6
|
|
Blood and lymphatic system disorders
Severe anemia
|
0.62%
2/325 • Up to month 6
|
|
Nervous system disorders
Paraplegia
|
0.31%
1/325 • Up to month 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer progression
|
0.31%
1/325 • Up to month 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone pain due to metastasis
|
0.62%
2/325 • Up to month 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectum tumor
|
0.31%
1/325 • Up to month 6
|
|
General disorders
Fever
|
0.31%
1/325 • Up to month 6
|
|
Gastrointestinal disorders
Entero-cutaneous fistula
|
0.31%
1/325 • Up to month 6
|
|
General disorders
Septic venous thrombophlebitis
|
0.31%
1/325 • Up to month 6
|
|
Infections and infestations
Septicemia due to catheter
|
0.31%
1/325 • Up to month 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urothelial tumor in the bladder
|
0.31%
1/325 • Up to month 6
|
|
Vascular disorders
Claudication
|
0.31%
1/325 • Up to month 6
|
|
General disorders
Asthenia
|
0.31%
1/325 • Up to month 6
|
|
Investigations
Weight gain
|
0.31%
1/325 • Up to month 6
|
|
Infections and infestations
Acute pneumonia
|
0.62%
2/325 • Up to month 6
|
|
Infections and infestations
Appendicitis acute
|
0.31%
1/325 • Up to month 6
|
|
Renal and urinary disorders
Urethral stricture
|
0.31%
1/325 • Up to month 6
|
|
Renal and urinary disorders
Urinary retention
|
0.31%
1/325 • Up to month 6
|
|
General disorders
Blocked nephrostomy catheter
|
0.31%
1/325 • Up to month 6
|
|
General disorders
Sudden death
|
0.31%
1/325 • Up to month 6
|
|
Immune system disorders
Allergy to conc med
|
0.31%
1/325 • Up to month 6
|
|
Renal and urinary disorders
Acute renal failure
|
0.31%
1/325 • Up to month 6
|
|
Respiratory, thoracic and mediastinal disorders
Right pleurisy
|
0.31%
1/325 • Up to month 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Right central pulmonary tumor malignant
|
0.31%
1/325 • Up to month 6
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.62%
2/325 • Up to month 6
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral pleural effusion
|
0.31%
1/325 • Up to month 6
|
|
Cardiac disorders
Cardio respiratory arrest
|
0.31%
1/325 • Up to month 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Larynx adenocarcinoma
|
0.31%
1/325 • Up to month 6
|
|
Infections and infestations
Pneumonia pneumocystis
|
0.31%
1/325 • Up to month 6
|
|
General disorders
Thoracic pain
|
0.31%
1/325 • Up to month 6
|
|
General disorders
Unspecific thoracic pain
|
0.31%
1/325 • Up to month 6
|
|
Reproductive system and breast disorders
Hemorrhage prostate
|
0.31%
1/325 • Up to month 6
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.31%
1/325 • Up to month 6
|
|
Gastrointestinal disorders
Right inguinal hernia
|
0.31%
1/325 • Up to month 6
|
|
Gastrointestinal disorders
Diarrhoea
|
0.31%
1/325 • Up to month 6
|
|
Infections and infestations
Chest infection
|
0.31%
1/325 • Up to month 6
|
|
Cardiac disorders
Atrial fibrillation
|
0.31%
1/325 • Up to month 6
|
|
Psychiatric disorders
Depression
|
0.31%
1/325 • Up to month 6
|
|
Injury, poisoning and procedural complications
Deliberate medication overdose
|
0.31%
1/325 • Up to month 6
|
|
Renal and urinary disorders
End stage renal failure
|
0.31%
1/325 • Up to month 6
|
|
Nervous system disorders
Spinal cord compression
|
0.31%
1/325 • Up to month 6
|
|
Renal and urinary disorders
Heamaturia
|
0.31%
1/325 • Up to month 6
|
|
Cardiac disorders
Myocardial infarction
|
0.31%
1/325 • Up to month 6
|
|
Musculoskeletal and connective tissue disorders
Increased pain in right thigh
|
0.31%
1/325 • Up to month 6
|
|
Blood and lymphatic system disorders
Anaemia
|
0.31%
1/325 • Up to month 6
|
Other adverse events
| Measure |
Triptorelin (Decapeptyl®) 22.5 mg
n=325 participants at risk
Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
|
|---|---|
|
Vascular disorders
Hot flush
|
27.4%
89/325 • Number of events 89 • Up to month 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place