Clinical trial · Observational
PROSTAC: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Docetaxel or Cabazitaxel.
Prospective Multi-centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Docetaxel or Cabazitaxel.
NCT02362620CI-TRIAL-00043033PROSTACunknownClinicalTrials.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)
PROSTAC is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with docetaxel or cabazitaxel
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 |
| Cabazitaxel | — | UNRESOLVED | — |
| Docetaxel | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Docetaxel
- description
- Docetaxel 75mg/m2 IV every 3 weeks
- label
- Cabazitaxel
- description
- Cabazitaxel 20-25mg/m2 IV every 3 weeks
Primary outcomes (1)
- measure
- To validate the prognostic value of the gene-expression signature from peripheral blood described by Olmos et al (Lancet Oncol 2012) on overall survival of mCRPC patients
- timeFrame
- 48 months
Secondary outcomes (7)
- measure
- To analyze the prognostic value of the gene-expression signature described by Olmos et al on biochemical and radiological progression-free survival
- timeFrame
- 48 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 adenocarcinome 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 docetaxel 75mg/m2 every 3 weeks or cabazitaxel 20-25mg/m2 every 3 weeks intravenously. 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.