| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|---|---|---|---|---|---|
| BIO-HRR-PANEL | ATM germline pathogenic | IB | Resistance or avoidance signal
| ATM germline pathogenic in mCRPC: olaparib approved per PROfound (Cohort A included ATM); benefit smaller than BRCA but FDA/EMA-labeled. Talazoparib+enzalutamide and olaparib+abiraterone also include ATM in HRR- mutated populations. ESCAT IB / OncoKB Level 1. | olaparib monotherapy (post-NHA) talazoparib + enzalutamide (1L, HRR-mut) |
|
| BIO-HRR-PANEL | ATM somatic loss-of-function | IB | Resistance or avoidance signal
| Somatic ATM loss-of-function in mCRPC: PROfound enrolled both germline and somatic ATM in Cohort A; olaparib indication covers both. ESCAT IB / OncoKB Level 1. | olaparib monotherapy (post-NHA, FDA) talazoparib + enzalutamide (1L, HRR-mut) |
|
| BIO-BRCA1-BRCA2-GERMLINE | BRCA1 germline pathogenic | IA | Resistance or avoidance signal
| BRCA1 germline pathogenic in mCRPC: olaparib improves rPFS and OS post-NHA (PROfound Cohort A, de Bono 2020); rucaparib (TRITON2/3) and niraparib (MAGNITUDE BRCA subset) also approved. 1L olaparib + abiraterone (PROpel) and niraparib + abiraterone (MAGNITUDE) extend rPFS in HRR-positive mCRPC. ESCAT IA / OncoKB Level 1. | olaparib monotherapy (post-NHA) olaparib + abiraterone + prednisone (1L) niraparib + abiraterone + prednisone (1L) talazoparib + enzalutamide (1L) rucaparib monotherapy (post-NHA + taxane) |
|
| BIO-HRR-PANEL | BRCA1 somatic loss-of-function | IA | Resistance or avoidance signal
| Somatic BRCA1 loss-of-function in mCRPC: PROfound enrolled both germline and somatic; olaparib benefit equivalent. PARPi labels in prostate cover both gBRCA and sBRCA. ESCAT IA / OncoKB Level 1. | olaparib monotherapy (post-NHA) olaparib + abiraterone (1L) niraparib + abiraterone (1L) talazoparib + enzalutamide (1L) |
|
| BIO-BRCA1-BRCA2-GERMLINE | BRCA2 germline pathogenic | IA | Resistance or avoidance signal
Trial or research option
| BRCA2 germline pathogenic in mCRPC: largest PARPi benefit in HRR pathway (PROfound Cohort A); olaparib post-NHA, 1L olaparib+abiraterone (PROpel), niraparib+abiraterone (MAGNITUDE), talazoparib+enzalutamide (TALAPRO-2) all approved. ESCAT IA / OncoKB Level 1. | olaparib monotherapy (post-NHA) olaparib + abiraterone (1L) niraparib + abiraterone (1L) talazoparib + enzalutamide (1L) rucaparib monotherapy |
|
| BIO-HRR-PANEL | BRCA2 somatic loss-of-function | IA | Resistance or avoidance signal
Trial or research option
| Somatic BRCA2 loss-of-function in mCRPC: PROfound included sBRCA; olaparib benefit equivalent to germline. Labels cover germline OR somatic. ESCAT IA / OncoKB Level 1. | olaparib monotherapy olaparib + abiraterone (1L) niraparib + abiraterone (1L) talazoparib + enzalutamide (1L) |
|
| BIO-HRR-PANEL | CHEK1 somatic loss-of-function | IIIA | Molecular evidence option
| Somatic CHEK1 loss-of-function in mCRPC: rare; PROfound included CHEK1 in Cohort B but small sample. Olaparib FDA label includes CHEK1 in HRR list. ESCAT IIIA / OncoKB Level 3B. | olaparib monotherapy (post-NHA, FDA HRR label) |
|
| BIO-HRR-PANEL | CHEK2 germline pathogenic | IB | Resistance or avoidance signal
| CHEK2 germline pathogenic in mCRPC: included in PROfound Cohort B; olaparib FDA HRR label (post-NHA) includes CHEK2 (FDA), though EMA label restricts to BRCA1/2. ESCAT IB (FDA jurisdiction) / OncoKB Level 1. | olaparib monotherapy (post-NHA, FDA HRR label) talazoparib + enzalutamide (HRR-mutated 1L) |
|
| BIO-HRR-PANEL | CHEK2 somatic loss-of-function | IB | Resistance or avoidance signal
| Somatic CHEK2 in mCRPC: PROfound enrolled both g/s; FDA olaparib HRR label includes CHEK2. ESCAT IB / OncoKB Level 1. | olaparib monotherapy (FDA HRR label) talazoparib + enzalutamide (HRR-mutated 1L) |
|
| Biomarker | Status |
|---|---|
| BIO-GLEASON-ISUP | BIO definition in KB; no ESCAT BMA entry — verify with clinician |
| BIO-PSA | BIO definition in KB; no ESCAT BMA entry — verify with clinician |
| BIO-BRCA-GERMLINE | BIO definition in KB; no ESCAT BMA entry — verify with clinician |
IND-PROSTATE-MCRPC-1L-PARPI| ID | Name | Priority | Category | Where to order | Needed for |
|---|---|---|---|---|---|
| TEST-PSA-SERUM | Serum PSA | Critical | — | — | all tracks |
| TEST-BONE-SCAN | Whole-body Tc-99m MDP bone scintigraphy | Standard | — | — | all tracks |
| TEST-GERMLINE-BRCA-PANEL | Germline BRCA1/2 + HRR panel sequencing | Standard | — | CSD Lab: M089 | all tracks |
| TEST-PSMA-PET | PSMA-PET/CT (Ga-68 or F-18) | Standard | — | — | desired (aggressive) |
| TEST-SOMATIC-HRR-PANEL | Tumor-tissue (or ctDNA) HRR-pathway NGS panel | Standard | — | CSD Lab: M065 CSD Lab ✓ (code TBC) | all tracks |
| TEST-TESTOSTERONE-SERUM | Serum total testosterone | Standard | — | — | all tracks |
| # | Owner | Topic | Action |
|---|---|---|---|
| 1 | hematologist | Staging / disease burden | What is the current LDH? Marker of tumor burden and transformation. |
| 2 | clinical_pharmacist | Specialist review | Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication. |
| 3 | molecular_geneticist | Specialist review | Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed. |
| Specialist | skill_id | Version | Last reviewed | Sign-offs | Domain |
|---|---|---|---|---|---|
| Cellular therapy specialist (CAR-T) | cellular_therapy_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
| Clinical pharmacist | clinical_pharmacist | v0.1.0 | 2026-04-25 | 0 | clinical_pharmacy |
| Hematologist / oncohematologist | hematologist | v0.1.0 | 2026-04-25 | 0 | hematology_oncology |
| Hematopathologist (lymphoma / leukemia / myeloma) | hematopathologist | v0.1.0 | 2026-04-25 | 0 | hematopathology |
| Infectious disease / hepatology | infectious_disease_hepatology | v0.1.0 | 2026-04-25 | 0 | infectious_diseases |
| Medical oncologist (solid-tumor chemotherapist) | medical_oncologist | v0.1.0 | 2026-04-25 | 0 | solid_oncology |
| Molecular geneticist / molecular oncologist | molecular_geneticist | v0.1.0 | 2026-04-25 | 0 | molecular_oncology |
| Palliative care | palliative_care | v0.1.0 | 2026-04-25 | 0 | palliative_care |
| Pathologist (general) | pathologist | v0.1.0 | 2026-04-25 | 0 | pathology |
| Primary care / family physician | primary_care | v0.1.0 | 2026-04-25 | 0 | primary_care |
| Psycho-oncologist | psychologist | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Radiation oncologist | radiation_oncologist | v0.1.0 | 2026-04-25 | 0 | radiation_oncology |
| Radiologist | radiologist | v0.1.0 | 2026-04-25 | 0 | diagnostic_imaging |
| Social worker / case manager | social_worker_case_manager | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Surgical oncologist | surgical_oncologist | v0.1.0 | 2026-04-25 | 0 | surgical_oncology |
| Transplant specialist (BMT) | transplant_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
| NCT | Title | Phase | Status | Sponsor | UA | Signals | Eligibility (excerpt) |
|---|---|---|---|---|---|---|---|
| NCT05498272 | Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With Select HRR Gene Alterations | PHASE2 | RECRUITING | Rana McKay, MD | — | Small N (<50) Single country |
Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.
| Option | UA registration | NSZU | Cost orientation | Access pathway |
|---|---|---|---|---|
| Aggressive plan Olaparib monotherapy (mCRPC, HRR-mutant) (REG-OLAPARIB-MONO) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Trial · NCT05498272 Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With Select HRR Gene Alterations No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-05-13.