Dutasteride (prostate cancer chemoprevention context)
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| ID | DRUG-DUTASTERIDE-CHEMOPREVENTION |
|---|---|
| Тип | Препарат |
| Синоніми | AvodartDuodart (with tamsulosin)Dutasteride (prostate cancer chemoprevention)Дутастерид (хіміопрофілактика раку передміхурової залози) |
| Статус | переглянуто 2026-05-18 | очікує клінічного підпису |
| Хвороби | Не вказано |
| Джерела | SRC-NCCN-PROSTATE-2025 SRC-USPSTF-PROSTATE-2018 |
Дані про препарат
| Клас | Dual 5-alpha-reductase type 1 + 2 inhibitor |
|---|---|
| Механізм дії | Competitive inhibitor of both type 1 and type 2 isoforms of 5-alpha- reductase, contrasting with finasteride (type 2 selective). Reduces intraprostatic and serum dihydrotestosterone (DHT) by ~90-95% — a more complete androgen blockade than finasteride. Prostate cancer prevention rationale identical to finasteride: lowering DHT reduces androgen-driven epithelial proliferation. REDUCE trial (Andriole NEJM 2010, NCT00056407): 23% relative reduction in prostate cancer incidence at 4 years in men with prior negative biopsy and elevated PSA, with a high-grade Gleason 8-10 signal similar to PCPT but modest (small absolute number). |
| Типове дозування | Prostate cancer chemoprevention (controversial / off-label, REDUCE protocol): 0.5 mg PO once daily ongoing. BPH dosing identical (0.5 mg/day). Steady-state intraprostatic DHT reduction ~6 months. PSA values reduce ~50% within 6-12 months — double measured PSA for cancer-screening interpretation. Very long terminal half-life (~5 weeks) means effects persist after discontinuation. |
| Зареєстровано в Україні | True |
| Відшкодовується НСЗУ | False |
| Остання перевірка для України | 2026-05-18 |
Нотатки
STUB — v0.2 chemoprevention-workstream authoring; pending two-Clinical- Co-Lead signoff per CHARTER §6.1 dev-mode. CONTROVERSIAL chemoprevention indication, mirrors finasteride. REDUCE trial (Andriole NEJM 2010): 23% relative risk reduction in prostate cancer over 4 years in men with elevated PSA and prior negative biopsy, BUT signal of slightly more Gleason 8-10 tumors (10 vs. 0 in years 3-4; small absolute number; detection-bias debated). FDA in 2011 declined chemoprevention indication for both finasteride and dutasteride citing high-grade signal. AUA / USPSTF 2018 — shared decision-making, no general- population recommendation. Strict pregnancy exclusion for partner; women must not handle capsules (transdermal absorption). Very long half-life — important for any consideration of paternity timing.
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