OpenOnco · DIS-PROSTATE · Actionable biomarker present
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OpenOnco · Treatment Plan
Treatment plan — Prostate adenocarcinoma
PLAN-VAR-PROSTATE-BIOMARK-V1 · v1 · 2026-05-12
Patient
VAR-PROSTATE-BIOMARK · Algorithm: ALGO-PROSTATE-MCRPC-1L
DiagnosisProstate adenocarcinoma
MOH / ICD-10C61
ICD-O-38140/3; C61.9

Clinical significance of mutations (ESCAT)

Tumor-board context — the engine does not use these tiers to rank tracks
✅ Covered biomarkers (matched in KB)
BiomarkerVariantESCATEvidenceClinical significanceDrugsSources
No clinically actionable variants matched in this profile.
⚠️ Not included in plan
BiomarkerStatus
BIO-GLEASON-ISUPBIO definition in KB; no ESCAT BMA entry — verify with clinician

Primary current-line option

Standard plan
★ DEFAULT
Indication
IND-PROSTATE-MCRPC-1L-ARPI
Regimen
ADT + enzalutamide (continuous)
Drugs + NSZU
  • Leuprolide (DRUG-LEUPROLIDE) 11.25 mg IM q3 months · Continuous · IM ✓ NSZU covered
  • Enzalutamide (DRUG-ENZALUTAMIDE) 160 mg PO daily · Continuous · PO ✓ NSZU covered
Supportive care
SUP-BONE-HEALTH-PROSTATE
Reason
Primary current-line option selected by ALGO-PROSTATE-MCRPC-1L at step 4.

Other current-line alternatives (1 tracks)

Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.
Aggressive plan
Indication
IND-PROSTATE-MCRPC-1L-PARPI
Regimen
Olaparib monotherapy (mCRPC, HRR-mutant)
Drugs + NSZU
  • Olaparib (DRUG-OLAPARIB) 300 mg PO BID continuous · Until progression or unacceptable toxicity · PO ⚠ NSZU — not for this indication
Supportive care
SUP-BONE-HEALTH-PROSTATE
Reason
Current-line alternative presented for HCP consideration

Pre-treatment investigations

Investigations before treatment start · critical / standard / desired · merged across tracks
IDNamePriorityCategoryWhere to orderNeeded for
TEST-PSA-SERUMSerum PSACriticalall tracks
TEST-BONE-SCANWhole-body Tc-99m MDP bone scintigraphyStandardall tracks
TEST-GERMLINE-BRCA-PANELGermline BRCA1/2 + HRR panel sequencingStandardCSD Lab: M089all tracks
TEST-PSMA-PETPSMA-PET/CT (Ga-68 or F-18)Standarddesired (aggressive, standard)
TEST-SOMATIC-HRR-PANELTumor-tissue (or ctDNA) HRR-pathway NGS panelStandardCSD Lab: M065
CSD Lab ✓ (code TBC)
aggressive
TEST-TESTOSTERONE-SERUMSerum total testosteroneStandardall tracks

Red flags — PRO / CONTRA aggressive

PRO-AGGRESSIVE

Triggers that push toward the aggressive track
  • AR (androgen receptor) gene amplification detected on tumor or ctDNA NGS in mCRPC — INFORMATIONAL signal of mechanistic ARSI resistance. AR amplification is one of the most common acquired resistance mechanisms to abiraterone / enzalutamide / apalutamide / darolutamide; detected in ~30-50% of post-ARSI mCRPC ctDNA samples. AR-amp argues against ARSI-after-ARSI sequencing (limited cross-class benefit) and for early switch to taxane chemotherapy (docetaxel, cabazitaxel) or radioligand 177Lu-PSMA-617 (if PSMA-PET-positive). FDA has NOT approved any therapy decision keyed on AR-amp status — surfaces in MDT brief to flag patients in whom further ARSI escalation is unlikely to add benefit. Companion to RF-PROSTATE-AR-V7-ARSI-RESISTANCE (AR-V7 splice variant); both detect distinct facets of AR-driven resistance. RF-PROSTATE-AR-AMP-ARSI-RESISTANCE
  • AR-V7 (androgen receptor splice variant 7) detected in CTCs / ctDNA in mCRPC — predictive marker of ARSI (abiraterone, enzalutamide, apalutamide, darolutamide) failure. PROPHECY (Antonarakis 2019): AR-V7-positive on Epic CTC IHC associated with HR ~3 for inferior PFS/OS on ARSI vs AR-V7-negative; switch to taxane (docetaxel, cabazitaxel) recovers responses. INFORMATIONAL — FDA has NOT approved any therapy decision keyed on AR-V7; surfaces in MDT brief to flag patients in whom ARSI-after-ARSI is unlikely to work. RF-PROSTATE-AR-V7-ARSI-RESISTANCE
  • Metastatic prostate cancer with malignant epidural spinal cord compression (MESCC): new motor deficit, sensory level, cauda equina syndrome, severe back pain with vertebral metastasis — prostate is the most common solid tumor cause of MESCCRF-PROSTATE-CORD-COMPRESSION
  • Germline or somatic BRCA1/2 mutation OR broader HRR pathway alteration (ATM, CDK12, PALB2, etc.) — predicts PARPi response; opens olaparib/talazoparib indication in mCRPC.RF-PROSTATE-HIGH-RISK-BIOLOGY
  • Renal dysfunction (CrCl <50 mL/min) or severe hepatic impairment (Child-Pugh C) — limits PARPi (olaparib renal-cleared) and ARPI (abiraterone hepatic) dosing.RF-PROSTATE-ORGAN-DYSFUNCTION
  • PCWG3-defined PSA progression on systemic prostate-cancer therapy: ≥25% rise from nadir + ≥2 ng/mL absolute increase, confirmed by a second value ≥3 weeks later. Triggers re-imaging + MDT consideration of next-line therapy switch — but NOT alone sufficient to change line if radiographic + clinical disease stable (per PCWG3 + STAR criteria). RF-PROSTATE-PSA-PROGRESSION
  • Spinal cord compression OR rapid PSA doubling time (<3 months) OR new visceral metastases — emergency or aggressive-progression flag requiring urgent intervention or treatment intensification.RF-PROSTATE-TRANSFORMATION-PROGRESSION

CONTRA-AGGRESSIVE

Hard contraindications to escalation

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Induction · ADT + enzalutamide (continuous)
28-day cycles × Continuous until progression or unacceptable toxicity

Aggressive plan

Induction · Olaparib monotherapy (mCRPC, HRR-mutant)
28-day cycles × Continuous until progression

MDT brief

Discussion questions (3, 1 blocking)

MDT talk tree (4 steps)

#OwnerTopicAction
1medical_oncologistBiomarker status BLOCKINGWhat 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.
2hematologistStaging / disease burden What is the current LDH? Marker of tumor burden and transformation.
3molecular_geneticistBiomarker 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.
4clinical_pharmacistSpecialist review Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.

Skills (recommended) — for consideration (2)

  • Clinical pharmacist recommended
    Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
  • Molecular geneticist / molecular oncologist recommended
    Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed.
    Owns: OQ-BIOMARKER-HRR-PANEL

Data quality

Incomplete for default-track review. Default-track review is incomplete until required biomarker gaps are resolved.
  • Biomarker coverage: 1/3 known (33%), 2 missing, 1 default-track gaps
  • Unevaluated RedFlags: RF-CHAARTED-HIGH-VOLUME-MHSPC, RF-LATITUDE-HIGH-RISK-MHSPC, RF-PAN-ATM-CHEK2-CDK12-PARPI-CANDIDATE, RF-PAN-BRCA-SOMATIC-PARPI-CANDIDATE, RF-PAN-PALB2-PARPI-CANDIDATE, RF-PROSTATE-AR-AMP-ARSI-RESISTANCE, RF-PROSTATE-AR-V7-ARSI-RESISTANCE, RF-PROSTATE-CORD-COMPRESSION, RF-PROSTATE-FRAILTY-AGE, RF-PROSTATE-HIGH-RISK-BIOLOGY, RF-PROSTATE-INFECTION-SCREENING, RF-PROSTATE-ORGAN-DYSFUNCTION, RF-PROSTATE-PSA-PROGRESSION, RF-PROSTATE-TMPRSS2-ERG-PROGNOSTIC, RF-PROSTATE-TRANSFORMATION-PROGRESSION
Missing biomarkerLabelMDT ownerDefault trackRequired byNext action
BIO-PSAProstate-specific antigen (PSA)medical_oncologistyesIND-PROSTATE-MCRPC-1L-ARPI, IND-PROSTATE-MCRPC-1L-PARPIVerify 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-PANELHomologous recombination repair (HRR) gene panel statusmolecular_geneticistnoIND-PROSTATE-MCRPC-1L-PARPIVerify result, method, specimen, and report date before sign-off. Expected/constraint: positive
Technical MDT skill metadata (2/16 activated in this plan)
All registered virtual specialists. ✓ — activated for this case; ○ — not activated (available for other clinical scenarios).
Specialistskill_idVersionLast reviewedSign-offsDomain
Cellular therapy specialist (CAR-T)cellular_therapy_specialistv0.1.02026-04-250cellular_therapy
Clinical pharmacistclinical_pharmacistv0.1.02026-04-250clinical_pharmacy
Hematologist / oncohematologisthematologistv0.1.02026-04-250hematology_oncology
Hematopathologist (lymphoma / leukemia / myeloma)hematopathologistv0.1.02026-04-250hematopathology
Infectious disease / hepatologyinfectious_disease_hepatologyv0.1.02026-04-250infectious_diseases
Medical oncologist (solid-tumor chemotherapist)medical_oncologistv0.1.02026-04-250solid_oncology
Molecular geneticist / molecular oncologistmolecular_geneticistv0.1.02026-04-250molecular_oncology
Palliative carepalliative_carev0.1.02026-04-250palliative_care
Pathologist (general)pathologistv0.1.02026-04-250pathology
Primary care / family physicianprimary_carev0.1.02026-04-250primary_care
Psycho-oncologistpsychologistv0.1.02026-04-250psychosocial
Radiation oncologistradiation_oncologistv0.1.02026-04-250radiation_oncology
Radiologistradiologistv0.1.02026-04-250diagnostic_imaging
Social worker / case managersocial_worker_case_managerv0.1.02026-04-250psychosocial
Surgical oncologistsurgical_oncologistv0.1.02026-04-250surgical_oncology
Transplant specialist (BMT)transplant_specialistv0.1.02026-04-250cellular_therapy

Sources cited

Experimental options (clinical trials)

Third plan track — open-enrollment trials from ClinicalTrials.gov. Render-time metadata; engine selection is not affected by this block (CHARTER §8.3). Last synced: 2026-05-12.
NCTTitlePhaseStatusSponsorUASignalsEligibility (excerpt)
NCT06850545Kuopio Lutetium-177 Study in Patients with PSMA-Positive Metastatic Prostate CancerN/ARECRUITINGKuopio University HospitalSingle country
NCT06446648Impact of Intraoperative ICG on Functional Outc in RARPEARLY_PHASE1RECRUITINGUniversity of California, IrvineSingle country
NCT06931340Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE TrialPHASE3RECRUITINGAlliance for Clinical Trials in OncologySingle country
NCT06257693Enzalutamide Implants (Enolen) in Patients With Prostate CancerPHASE1RECRUITINGAlessa Therapeutics Inc.Phase 1 only Single country
NCT06451497This 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 TumorsPHASE1RECRUITINGZumutor Biologics Inc.Phase 1 only Single country
NCT07219147177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate CancerPHASE1RECRUITINGCity of Hope Medical CenterPhase 1 only Small N (<50) Surrogate endpoint only Single country
NCT07426055PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate CancerPHASE2 / PHASE3RECRUITINGAffidea Nu-med Center of Oncological DIagnostics and TherapySingle country
NCT07407608ABlative Radiotherapy (for) Unfavorable Prostate Tumors 2.0N/ARECRUITINGUniversity of Milano BicoccaSingle country
NCT05519878Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary CancersNARECRUITINGCity of Hope Medical CenterSingle country
NCT04625556Development of Urologic Registry for Personalized Medicine in Patients With Urologic Malignant Diseases by Analyzing MicrobiomeN/ARECRUITINGYonsei UniversitySurrogate endpoint only Single country

Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.

Option availability in Ukraine

Per-track UA registration · NSZU · cost · access pathway. Render-time metadata; engine selection does not depend on these fields (CHARTER §8.3).
OptionUA registrationNSZUCost orientationAccess pathway
Standard plan
ADT + enzalutamide (continuous) (REG-ADT-ENZALUTAMIDE)
✓ registered✓ covered₴-? — verify pathwayNSZU formulary
Aggressive plan
Olaparib monotherapy (mCRPC, HRR-mutant) (REG-OLAPARIB-MONO)
✓ registered✓ covered₴-? — verify pathwayNSZU 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.