Clinical trial · Observational
PROSENZA: Prospective Multi-Centre Study of Prognostic Factors in mCRPC Patients Treated With Enzalutamide.
Prospective Multi-Centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Enzalutamide.
NCT02922218CI-TRIAL-00043032PROSENZAunknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
PROSENZA is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with enzalutamide
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Castration Resistant | — | UNRESOLVED | — |
| Enzalutamide | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Enzalutamide
- description
- Enzalutamide 160 mg/day c/24h
Primary outcomes (1)
- measure
- To assess the prognostic value for overall survival of androgen receptor splicing variant 7 (AR-V7) and/or AR amplification in mCRPC patients
- timeFrame
- Initially 48 months, currently 60 months
Secondary outcomes (4)
- measure
- To analyze the correlation between biochemical and/or radiological response with AR-V7 expression and/or AR amplification in mCRPC patients treated with Enzalutamide.
- timeFrame
- Initially 48 months, currently 60 months
- measure
- To assess AR-V7 expression and/or AR amplification changes before and after enzalutamide treatment
- timeFrame
- Initially 48 months, currently 60 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male age ≥ 18 years 2. Histologically confirmed adenocarcinoma of the prostate 3. ECOG Performance Status ≤ 2 4. Castration resistance must be documented with surgical or medical castration with serum testosterone \< 50 ng/mL (\< 2.0 nM). 5. Men diagnosed with at least one metastatic lesion on CT or bone scan. 6. Documented biochemical and/or radiographic progression to previous treatment according to PCWG2 criteria. 7. Patients who are candidates for standard of care treatment with enzalutamide 160 mg every 24 hours. 8. Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy. 9. Acceptable hematological, hepatic and renal functions. Exclusion Criteria: 1. Previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ carcinomas. 2. Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data
References
Publications (0)
Data not yet available
No reference posted for this study.