Clinical trial · Observational
Aggressive Disease Treatment Patterns and CtDNA HRR evaluatiON in High-volume metastatiC hORmone-sensitive Prostate Cancer in Russian FeDeration
A Multicentre Observational Study on Treatment Patterns and ctDNA HRR Evaluation in Aggressive High-volume Metastatic Hormone-sensitive Prostate Cancer in Russian Federation
NCT07052578CI-TRIAL-00122499CONCORDrecruitingClinicalTrials.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)
A multicentre observational study on treatment patterns and ctDNA HRR evaluation in aggressive high-volume metastatic hormone-sensitive prostate cancer in Russian Federation
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (15)
- measure
- Proportion of patients received any ADT
- timeFrame
- 36 months
- description
- Proportion of patients received any Androgen deprivation therapy
- measure
- Proportion of patients received ADT by each type and by each drug
- timeFrame
- 36 months
- description
- Proportion of patients received Androgen deprivation therapy by each type and by each drug
- measure
- Proportion of patients received first generation antiandrogens
- timeFrame
- 36 months
- description
- Proportion of patients received first generation antiandrogens
- measure
- Proportion of patients received androgen receptor pathway inhibitors (ARPI) at mHSPC
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male patients aged ≥ 18 years old; 2. Signed ICF, including consent for blood samples ctDNA and ctDNA-based HRRm testing; 3. Metastatic hormone-sensitive prostate cancer (mHSPC) (de novo or progressed from earlier stages); 4. High-aggressive disease (Gleason 8-10); 5. High-volume disease (according to CHAARTED trial criteria: presence of 4 and more (≥4) bone metastases (including at least one (≥1) outside the vertebral column/pelvis) and/or 1 and more (≥1) visceral metastasis); 6. Availability of source medical documentation; 7. Known HRRm status based on tumour sample evaluation performed in routine practice. Exclusion Criteria: 1. Participation in any interventional trial since the mPC diagnosis. 2. Progression to mCRPC.
References
Publications (0)
Data not yet available
No reference posted for this study.