| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|---|---|---|---|---|---|
| No clinically actionable variants matched in this profile. | ||||||
| Biomarker | Status |
|---|---|
| BIO-GLEASON-ISUP | BIO definition in KB; no ESCAT BMA entry — verify with clinician |
| 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, standard) |
| TEST-SOMATIC-HRR-PANEL | Tumor-tissue (or ctDNA) HRR-pathway NGS panel | Standard | — | CSD Lab: M065 CSD Lab ✓ (code TBC) | aggressive |
| TEST-TESTOSTERONE-SERUM | Serum total testosterone | Standard | — | — | all tracks |
| # | Owner | Topic | Action |
|---|---|---|---|
| 1 | medical_oncologist | Biomarker status BLOCKING | What is the status of Prostate-specific antigen (PSA) (BIO-PSA)? It is required by track(s): IND-PROSTATE-MCRPC-1L-ARPI, IND-PROSTATE-MCRPC-1L-PARPI. Expected value: PSA baseline + on-treatment per PCWG3 — mandatory response/progression marker; reportable across all systemic prostate indications. |
| 2 | hematologist | Staging / disease burden | What is the current LDH? Marker of tumor burden and transformation. |
| 3 | molecular_geneticist | Biomarker status | What is the status of Homologous recombination repair (HRR) gene panel status (BIO-HRR-PANEL)? It is required by track(s): IND-PROSTATE-MCRPC-1L-PARPI. Expected value: positive. |
| 4 | clinical_pharmacist | Specialist review | Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication. |
| Missing biomarker | Label | MDT owner | Default track | Required by | Next action |
|---|---|---|---|---|---|
BIO-PSA | Prostate-specific antigen (PSA) | medical_oncologist | yes | IND-PROSTATE-MCRPC-1L-ARPI, IND-PROSTATE-MCRPC-1L-PARPI | Verify result, method, specimen, and report date before sign-off. Expected/constraint: PSA baseline + on-treatment per PCWG3 — mandatory response/progression marker; reportable across all systemic prostate indications |
BIO-HRR-PANEL | Homologous recombination repair (HRR) gene panel status | molecular_geneticist | no | IND-PROSTATE-MCRPC-1L-PARPI | Verify result, method, specimen, and report date before sign-off. Expected/constraint: positive |
| 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) |
|---|---|---|---|---|---|---|---|
| NCT06724159 | Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors. | N/A | RECRUITING | Spanish Oncology Genito-Urinary Group | — | Single country | |
| NCT05832086 | Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes | PHASE2 | RECRUITING | Stephen Freedland | — | Single country | |
| NCT06612580 | 68Ga-AAZTA-NI-093 PET/CT: First-in-human Study | EARLY_PHASE1 | RECRUITING | First Affiliated Hospital of Fujian Medical University | — | Small N (<50) Single country | |
| NCT06369610 | Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment of Prostate Cancer | PHASE2 | RECRUITING | Mayo Clinic | — | Single country | |
| NCT07391982 | Dose De-escalation in Prostate Radiotherapy Using an MR-Linac in Two Fractions | NA | RECRUITING | The Netherlands Cancer Institute | — | Single country | |
| NCT06022822 | Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial | PHASE2 | RECRUITING | National Cancer Institute (NCI) | — | Single country | |
| NCT06392295 | PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer | PHASE2 | RECRUITING | University of Miami | — | Small N (<50) Surrogate endpoint only Single country | |
| NCT06717295 | The CCANED-CIPHER Study: Early Cancer Detection and Treatment Response Monitoring Using AI-Based Platelet and Immune Cell Transcriptomic Profiling | N/A | RECRUITING | Javier Toledo | — | Surrogate endpoint only | |
| NCT03821246 | Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy | PHASE2 | RECRUITING | David Oh | — | Single country | |
| NCT06101290 | Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER) | NA | RECRUITING | University of California, Davis | — | 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 |
|---|---|---|---|---|
| Standard plan ADT + enzalutamide (continuous) (REG-ADT-ENZALUTAMIDE) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Aggressive plan Olaparib monotherapy (mCRPC, HRR-mutant) (REG-OLAPARIB-MONO) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Trial · NCT06724159 Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors. No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05832086 Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06612580 68Ga-AAZTA-NI-093 PET/CT: First-in-human Study No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06369610 Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment of Prostate Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07391982 Dose De-escalation in Prostate Radiotherapy Using an MR-Linac in Two Fractions No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06022822 Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06392295 PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06717295 The CCANED-CIPHER Study: Early Cancer Detection and Treatment Response Monitoring Using AI-Based Platelet and Immune Cell Transcriptomic Profiling No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT03821246 Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06101290 Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER) 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: 2026-06-11.