| 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) |
|---|---|---|---|---|---|---|---|
| NCT06850545 | Kuopio Lutetium-177 Study in Patients with PSMA-Positive Metastatic Prostate Cancer | N/A | RECRUITING | Kuopio University Hospital | — | Single country | |
| NCT06446648 | Impact of Intraoperative ICG on Functional Outc in RARP | EARLY_PHASE1 | RECRUITING | University of California, Irvine | — | Single country | |
| NCT06931340 | Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial | PHASE3 | RECRUITING | Alliance for Clinical Trials in Oncology | — | Single country | |
| NCT06257693 | Enzalutamide Implants (Enolen) in Patients With Prostate Cancer | PHASE1 | RECRUITING | Alessa Therapeutics Inc. | — | Phase 1 only Single country | |
| NCT06451497 | This is a Phase 1 Trial of ZM008, an Anti-LLT1 Antibody, Used as Single Agent Followed by Combination Treatment With Toripalimab in Patients With Advanced Solid Tumors | PHASE1 | RECRUITING | Zumutor Biologics Inc. | — | Phase 1 only Single country | |
| NCT07219147 | 177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer | PHASE1 | RECRUITING | City of Hope Medical Center | — | Phase 1 only Small N (<50) Surrogate endpoint only Single country | |
| NCT07426055 | PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate Cancer | PHASE2 / PHASE3 | RECRUITING | Affidea Nu-med Center of Oncological DIagnostics and Therapy | — | Single country | |
| NCT07407608 | ABlative Radiotherapy (for) Unfavorable Prostate Tumors 2.0 | N/A | RECRUITING | University of Milano Bicocca | — | Single country | |
| NCT05519878 | Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers | NA | RECRUITING | City of Hope Medical Center | — | Single country | |
| NCT04625556 | Development of Urologic Registry for Personalized Medicine in Patients With Urologic Malignant Diseases by Analyzing Microbiome | N/A | RECRUITING | Yonsei University | — | Surrogate endpoint only 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 · NCT06850545 Kuopio Lutetium-177 Study in Patients with PSMA-Positive Metastatic Prostate Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06446648 Impact of Intraoperative ICG on Functional Outc in RARP No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06931340 Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06257693 Enzalutamide Implants (Enolen) in Patients With Prostate Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06451497 This is a Phase 1 Trial of ZM008, an Anti-LLT1 Antibody, Used as Single Agent Followed by Combination Treatment With Toripalimab in Patients With Advanced Solid Tumors No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07219147 177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07426055 PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07407608 ABlative Radiotherapy (for) Unfavorable Prostate Tumors 2.0 No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05519878 Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT04625556 Development of Urologic Registry for Personalized Medicine in Patients With Urologic Malignant Diseases by Analyzing Microbiome 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: 2026-05-12.