Prostate Cancer
Conditions
Keywords
Locally advanced or metastatic Prostate Cancer
Brief summary
The purpose of this study is to evaluate the effect of an initial hormonal treatment gonadotrophin-releasing hormone (GnRH Agonist) on 2 biomarkers (PCA3 and TMPRSS2-ERG), in patients with histologically confirmed and advanced stages of prostate cancer. Their characteristics, according to risk factors such as PSA and Gleason score will be determined at baseline and 1, 3 and 6 month post-treatment.
Interventions
One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
Sponsors
Ipsen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A histologically confirmed, locally advanced or metastatic prostate cancer, and naïve to androgen deprivation therapy, and a candidate for hormonal treatment. * An estimated survival time of at least twelve months according to the investigator's assessment. * A performance status score ≤ 2 according to the World Health Organisation (WHO) criteria.
Exclusion criteria
* Previous surgical castration. * Previous or has planned curative prostate cancer therapy (radiation/surgery) * Previous hormone therapy (GnRH analogues, estrogens or anti-androgens) * Patients with risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or significant obstructive uropathy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA | At month 6 post-treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA | At month 1 and 3 post-treatment | 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 |
| TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA) | At baseline, month 1, 3 and 6 post-treatment | 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.' |
| Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL) | At month 1, 3 and 6 post-treatment | — |
| PSA Level | At baseline, month 1, 3 and 6 post-treatment | — |
| Safety, Assessed Through the Collection of Adverse Events (AEs) | For the duration of the study (up to month 6) | — |
Countries
Belgium, Denmark, France, Italy, Latvia, Lithuania, Netherlands, Romania, Spain, United Kingdom
Participant flow
Recruitment details
Study Initiation Date: 30-Nov-2009. Subjects screened were 339 and screen failures were 13.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 325 |
| Total | 325 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Pre-assignment | Adverse Event | 6 |
| Pre-assignment | Does Not Meet Entry Criteria | 2 |
| Pre-assignment | Withdrawal by Subject | 5 |
| 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
| Characteristic | Triptorelin (Decapeptyl®) 22.5 mg |
|---|---|
| Age, Continuous | 72.6 years STANDARD_DEVIATION 8.4 |
| BMI | 26.79 kg/m² STANDARD_DEVIATION 4.23 |
| Height | 172.3 Cm STANDARD_DEVIATION 6.5 |
| PCA-3 Score <35 | 89 participants |
| PCA-3 Score ≥35 | 179 participants |
| PCA-3 Score ≤BLQ | 15 participants |
| PCA-3 Score Missing - No sample analysis done | 3 participants |
| PCA-3 Score Non-assessable | 39 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) White | 307 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 325 Participants |
| Weight | 79.6 KG STANDARD_DEVIATION 13.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 89 / 325 |
| serious Total, serious adverse events | 37 / 325 |
Outcome results
Primary
PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA
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
Time frame: At month 6 post-treatment
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Triptorelin (Decapeptyl®) 22.5 mg | PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA | ≤BLQ | 27 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA | <35 | 10 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA | ≥35 | 24 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | 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 |
| Triptorelin (Decapeptyl®) 22.5 mg | PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA | Non-assessable | 232 participants |
Secondary
PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA
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
Time frame: At month 1 and 3 post-treatment
Population: Analysis based on number (N) of patients with a valid value. Intention-to-treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Triptorelin (Decapeptyl®) 22.5 mg | PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA | Month 1: Non-assessable (N=322) | 109 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA | Month 1: ≤BLQ (N=322) | 40 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA | Month 1: <35 (N=322) | 80 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA | Month 1: ≥35 (N=322) | 91 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA | Month 1: Missing - No sample analysis done (N=322) | 2 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA | Month 3: Non-assessable (N=313) | 215 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA | Month 3: ≤BLQ (N=313) | 31 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA | Month 3: <35 (N=313) | 34 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA | Month 3: ≥35 (N=313) | 31 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA | Month 3: Missing - No sample analysis done (N=313) | 2 participants |
Secondary
Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL)
Time frame: At month 1, 3 and 6 post-treatment
Population: Analysis based on number (N) of patients with a valid value. ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Triptorelin (Decapeptyl®) 22.5 mg | Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL) | Month 1 (N=322) | 94.7 percentage of participants |
| Triptorelin (Decapeptyl®) 22.5 mg | Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL) | Month 3 (N=313) | 95.2 percentage of participants |
| Triptorelin (Decapeptyl®) 22.5 mg | Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL) | Month 6 (N=298) | 90.9 percentage of participants |
Secondary
PSA Level
Time frame: At baseline, month 1, 3 and 6 post-treatment
Population: Analysis based on number (N) of patients with a valid value. ITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Triptorelin (Decapeptyl®) 22.5 mg | PSA Level | Baseline (N=321) | 45.4 μg/L |
| Triptorelin (Decapeptyl®) 22.5 mg | PSA Level | Month 1 (N=320) | 8.3 μg/L |
| Triptorelin (Decapeptyl®) 22.5 mg | PSA Level | Month 3 (N=311) | 1.8 μg/L |
| Triptorelin (Decapeptyl®) 22.5 mg | PSA Level | Month 6 (N=296) | 1.2 μg/L |
Secondary
Safety, Assessed Through the Collection of Adverse Events (AEs)
Time frame: For the duration of the study (up to month 6)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Triptorelin (Decapeptyl®) 22.5 mg | Safety, Assessed Through the Collection of Adverse Events (AEs) | Any Adverse Events (AEs) | 193 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | Safety, Assessed Through the Collection of Adverse Events (AEs) | Any Treatment Emergent Adverse Events (TEAEs) | 190 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | Safety, Assessed Through the Collection of Adverse Events (AEs) | TEAEs Leading to Withdrawal | 11 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | Safety, Assessed Through the Collection of Adverse Events (AEs) | TEAEs Leading to Death | 11 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | Safety, Assessed Through the Collection of Adverse Events (AEs) | Serious Adverse Events (SAEs) | 37 participants |
Secondary
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
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.'
Time frame: At baseline, month 1, 3 and 6 post-treatment
Population: Analysis based on number (N) of patients with a valid value. ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Triptorelin (Decapeptyl®) 22.5 mg | TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA) | Baseline: Non-assessable (N=322) | 33 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA) | Baseline: <35 negative (N=322) | 140 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA) | Baseline: ≥35 positive (N=322) | 149 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA) | Month 1: Non-assessable (N=322) | 117 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA) | Month 1: <35 negative (N=322) | 97 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA) | Month 1: ≥35 positive (N=322) | 106 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | 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 |
| Triptorelin (Decapeptyl®) 22.5 mg | TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA) | Month 3: Non-assessable (N=313) | 213 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA) | Month 3: <35 negative (N=313) | 45 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA) | Month 3: ≥35 positive (N=313) | 53 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | 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 |
| Triptorelin (Decapeptyl®) 22.5 mg | TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA) | Month 6: Non-assessable (N=298) | 241 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA) | Month 6: <35 negative (N=298) | 24 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA) | Month 6: ≥35 positive (N=298) | 27 participants |
| Triptorelin (Decapeptyl®) 22.5 mg | 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 |