OpenOnco · Treatment Plan

Treatment plan — Prostate adenocarcinoma

PLAN-VAR-PROSTATE-HIGHRISK-V1 · v1 · 2026-05-13

Patient

VAR-PROSTATE-HIGHRISK · 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)

Biomarker	Variant	ESCAT	Evidence	Clinical significance	Drugs	Sources
No clinically actionable variants matched in this profile.

⚠️ Not included in plan

Biomarker	Status
BIO-GLEASON-ISUP	BIO 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

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

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 (2, 1 blocking)

BLOCKING OQ-BIOMARKER-PSA
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.
A treatment-track biomarker requirement is missing from the patient profile; the MDT should verify the test result, method, specimen, and date before relying on this option.
→ medical_oncologist
OQ-BIOMARKER-HRR-PANEL
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.
A treatment-track biomarker requirement is missing from the patient profile; the MDT should verify the test result, method, specimen, and date before relying on this option.
→ molecular_geneticist

MDT talk tree (4 steps)

#	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	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.
3	clinical_pharmacist	Specialist review	Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
4	radiologist	Specialist review	Imaging findings present — radiologist needed for staging/restaging.

Skills (recommended) — for consideration (3)

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
Radiologist recommended
Imaging findings present — radiologist needed for staging/restaging.

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 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

Technical MDT skill metadata (3/16 activated in this plan)

All registered virtual specialists. ✓ — activated for this case; ○ — not activated (available for other clinical scenarios).

Specialist	skill_id	Version	Last reviewed	Domain
Cellular therapy specialist (CAR-T)	`cellular_therapy_specialist`	v0.1.0	2026-04-25	cellular_therapy
Clinical pharmacist	`clinical_pharmacist`	v0.1.0	2026-04-25	clinical_pharmacy
Hematologist / oncohematologist	`hematologist`	v0.1.0	2026-04-25	hematology_oncology
Hematopathologist (lymphoma / leukemia / myeloma)	`hematopathologist`	v0.1.0	2026-04-25	hematopathology
Infectious disease / hepatology	`infectious_disease_hepatology`	v0.1.0	2026-04-25	infectious_diseases
Medical oncologist (solid-tumor chemotherapist)	`medical_oncologist`	v0.1.0	2026-04-25	solid_oncology
Molecular geneticist / molecular oncologist	`molecular_geneticist`	v0.1.0	2026-04-25	molecular_oncology
Palliative care	`palliative_care`	v0.1.0	2026-04-25	palliative_care
Pathologist (general)	`pathologist`	v0.1.0	2026-04-25	pathology
Primary care / family physician	`primary_care`	v0.1.0	2026-04-25	primary_care
Psycho-oncologist	`psychologist`	v0.1.0	2026-04-25	psychosocial
Radiation oncologist	`radiation_oncologist`	v0.1.0	2026-04-25	radiation_oncology
Radiologist	`radiologist`	v0.1.0	2026-04-25	diagnostic_imaging
Social worker / case manager	`social_worker_case_manager`	v0.1.0	2026-04-25	psychosocial
Surgical oncologist	`surgical_oncologist`	v0.1.0	2026-04-25	surgical_oncology
Transplant specialist (BMT)	`transplant_specialist`	v0.1.0	2026-04-25	cellular_therapy

Sources cited

SRC-ESMO-PROSTATE-2024: ESMO Clinical Practice Guideline on Prostate Cancer (2024)
SRC-NCCN-PROSTATE-2025: NCCN Clinical Practice Guidelines — Prostate Cancer (2025.v3)

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: 2026-05-13.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT06238713	Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)	NA	RECRUITING	Shanghai Changzheng Hospital	—	Single country
NCT04693377	Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial	NA	RECRUITING	M.D. Anderson Cancer Center	—	Small N (<50) Single country
NCT05998278	Personalized Optimization of Systematic Prostate Biopsy	NA	RECRUITING	Fujian Medical University Union Hospital	—	Single country
NCT06943521	A Study of MT-4561 in Patients With Various Advanced Solid Tumors	PHASE1 / PHASE2	RECRUITING	Tanabe Pharma America, Inc.	—	Small N (<50)
NCT04373564	Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years	PHASE4	RECRUITING	Guerbet	—	—
NCT05113537	Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer	PHASE1 / PHASE2	RECRUITING	Vadim S Koshkin	—	Small N (<50) Single country
NCT07339943	Micro-ultrasound-Guided Focal Laser Ablation for Intermediate-Risk Prostate Cancer: Safety & Effectiveness	NA	RECRUITING	University Health Network, Toronto	—	Small N (<50) Single country
NCT07410494	Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors	PHASE1 / PHASE2	RECRUITING	Essen Biotech	—	Single country
NCT06440018	INSPIRE: a Multi-Cancer Early Detection Study	N/A	RECRUITING	Singlera Genomics Inc.	—	Single country
NCT06039371	Supraphysiological Androgen to Enhance Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study	PHASE2	RECRUITING	University of Washington	—	Surrogate 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).

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 · NCT06238713 Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04693377 Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05998278 Personalized Optimization of Systematic Prostate Biopsy No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06943521 A Study of MT-4561 in Patients With Various Advanced Solid Tumors No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04373564 Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05113537 Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07339943 Micro-ultrasound-Guided Focal Laser Ablation for Intermediate-Risk Prostate Cancer: Safety & Effectiveness No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07410494 Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06440018 INSPIRE: a Multi-Cancer Early Detection Study No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06039371 Supraphysiological Androgen to Enhance Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study 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.

plan_id: PLAN-VAR-PROSTATE-HIGHRISK-V1 | version: 1 | generated: 2026-05-13T10:01:52.636620+00:00

Per FDA non-device CDS positioning (CHARTER §15): Outpatient oncology treatment planning to support tumor-board discussion. Not a medical device; not for autonomous clinical decision-making.

Per FDA non-device CDS positioning (CHARTER §15): Both treatment options below are presented for review. The engine's selection of a 'recommended' default does not constitute a clinical decision. Final treatment selection requires HCP judgment incorporating information not available to the system.

This document is an informational resource supporting tumor-board discussion (per CHARTER §11). It is not a system that makes clinical decisions. Every recommendation must be verified by the treating physician.