Clinical trial · Interventional
Effect of Triptorelin (Decapeptyl®) 22.5 mg on Two Biomarkers in Patients With Advanced Prostate Cancer
Prostate Cancer Antigen-3 (PCA-3) and TMPRSS2-ERG (T2-ERG) Score Changes During Initiation of Androgen Deprivation Therapy (ADT) With Triptorelin 22.5mg in Patients With Advanced Prostate Cancer (PCA): A Phase III, Single Arm Multicentre Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Triptorelin (Decapeptyl®) | Drug | Triptorelin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Triptorelin (Decapeptyl®) 22.5 mg
- interventionNames
- Drug: Triptorelin (Decapeptyl®)
Primary outcomes (1)
- measure
- PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA
- timeFrame
- At month 6 post-treatment
- description
- 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 outcomes (5)
- measure
- PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA
- timeFrame
- At month 1 and 3 post-treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available