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name: b56-prostate-cancer-programme description: "Polish NFZ drug programme B.56 for prostate cancer (ICD-10 C61). Use when helping clinicians with patient qualification, drug selection, dosing, monitoring, or follow-up for mHSPC, nmCRPC, or mCRPC treatment with apalutamide, darolutamide, enzalutamide, olaparib, niraparib+abiraterone, or talazoparib. Covers eligibility criteria, required diagnostics, treatment duration, and exclusion criteria."

B.56 Programme - Prostate Cancer Treatment (ICD-10: C61)

Quick Reference: Drug Selection by Disease Stage

*Requires BRCA1/2 or HRR gene mutations

Programme Rules

• ONE new-generation hormonal therapy line allowed
• ONE PARP inhibitor line allowed
• One-time use of non-steroidal antiandrogen AND PARP inhibitor permitted

General Qualification Criteria (All Drugs)

All patients must meet:

1. Histologically confirmed prostate adenocarcinoma
2. Age ≥18 years
3. Performance status per drug-specific requirements (see below)
4. Adequate organ function per SmPC
5. No contraindications per SmPC
6. No uncontrolled other malignancies
7. No neuroendocrine/small-cell/ductal prostate cancer

Performance Status Requirements

Drug Dosing

Mandatory Castration Maintenance

All patients (except post-orchiectomy) must maintain androgen suppression with LHRH agonists/antagonists.

Decision Trees

For mHSPC Patients

CopymHSPC confirmed?
├─ Can receive docetaxel?
│   ├─ Yes → Darolutamide + Docetaxel OR Apalutamide/Enzalutamide
│   └─ No (documented reason) → Apalutamide OR Enzalutamide
├─ Prior ADT ≤6 months on metastatic disease? → Eligible
├─ Prior abiraterone? → NOT eligible
└─ Prior radical treatment + adjuvant HT ≤3 years (finished ≥1 year ago)? → Eligible

For nmCRPC Patients

CopynmCRPC criteria:
├─ Testosterone ≤50 ng/dL (≤1.7 nmol/L)?
├─ PSA progression (3 rises, ≥1 week apart, 2×≥50% from nadir, PSA >2)?
├─ No distant metastases (M0, only N1 <2cm below aortic bifurcation)?
├─ PSA doubling time ≤10 months?
└─ No prior abiraterone?
All YES → Eligible for Apalutamide/Darolutamide/Enzalutamide

Note: Apalutamide/Enzalutamide - exclude if seizure history or risk factors

For mCRPC Patients

CopymCRPC criteria:
├─ Testosterone ≤50 ng/dL (≤1.7 nmol/L)?
├─ PSA progression OR radiological progression?
│
├─ BRCA1/2 mutation present?
│   ├─ Yes + prior new-gen hormonal therapy progression → Olaparib eligible
│   └─ Yes + no chemo indication in 1st line mCRPC + no prior abiraterone → Niraparib+Abi eligible
│
├─ HRR mutation (BRCA2, ATM, CDK12, CHEK2, BRCA1, PALB2, RAD51C)?
│   └─ Yes + no chemo indication + no prior abiraterone → Talazoparib+Enzalutamide eligible
│
└─ No targetable mutation?
    └─ Enzalutamide (pre- or post-docetaxel)

Required Diagnostics

See references/diagnostics.md for complete lists.

At Qualification

• Histology confirmation
• CBC with differential
• PSA, testosterone
• Creatinine (+ eGFR for olaparib/talazoparib)
• Bilirubin, ALT, AST
• Bone scan
• Imaging (CT/MRI) per clinical indication
• CT abdomen/pelvis (for nmCRPC drugs)
• Chest imaging (for nmCRPC drugs)

Imaging must be ≤3 months before enrolment and allow RECIST/PCWG evaluation.

Monitoring Schedule

See references/monitoring.md for complete protocol.

Safety Monitoring

• CBC: every 2-3 months (monthly for PARP inhibitors)
• Creatinine + eGFR: monthly for olaparib/niraparib+abi/talazoparib
• For darolutamide+docetaxel phase: labs before each docetaxel dose

Efficacy Monitoring

• PSA: minimum every 3 months
• Imaging (per baseline modality): minimum every 6 months
• Bone scan: minimum every 6 months

Exclusion Criteria

See references/exclusion-criteria.md for details.

Progression Definitions

PSA progression: 3 consecutive rises (≥1 week apart), 2 rises ≥50% above nadir, PSA >2 ng/mL

• Exception: continue if documented clinical benefit and no next-line option

Radiological progression: per RECIST (soft tissue) or PCWG (bone)

Other Exclusion Triggers

• ECOG deterioration (drug-specific thresholds)
• Hypersensitivity to drug/excipients
• Unmanageable toxicity per SmPC/physician judgment
• Conditions precluding treatment
• Significant QoL deterioration
• Non-compliance with follow-up

Special Populations

Renal Impairment (Olaparib, Talazoparib)

• CrCl 31-50 mL/min: dose reduction per SmPC
• CrCl ≤30 mL/min: contraindicated

Patients Continuing from Other Funding

Patients previously on programme drugs via other funding (except ongoing clinical trials) may qualify if they met criteria at treatment initiation.