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선택지 정리됨

Prostate cancer: 국가별 선택지

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선택지 정리됨고형암최종 확인 2026.06

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임상시험 검색어

Prostate cancer clinical trial

국가별 선택지

국가별 치료 선택지

공식 규제·평가 기관 출처를 바탕으로 한 국가별 승인·접근 상태입니다. 무엇이 어디에 존재하는지를 보여줄 뿐, 추천이 아닙니다.

United States

  • darolutamide (Nubeqa)[1]Approvedno required molecular biomarker; non-metastatic castration-resistant prostate cancer; adult non-metastatic castration-resistant prostate cancer in the United States. · The current label confirms broader active U.S. indications, but this finding is limited to the nmCRPC setting and does not establish reimbursement or comparative positioning versus enzalutamide/apalutamide. Dose reductions are specified for severe renal impairment not on hemodialysis and moderate hepatic impairment. Confidence/conflicts: High for current U.S. label scope including nmCRPC; no source conflict identified.
  • enzalutamide (Xtandi)[2]Approvedno required molecular biomarker; non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis; non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis in the United States. · The label verifies the U.S. indication and GnRH wording but does not establish payer coverage, sequencing preference against salvage local therapy, or individual candidacy. Seizure, falls/fractures, cardiovascular, and swallowing-size warnings remain material label considerations. Confidence/conflicts: High for current U.S. label indication and administration framing; no source conflict identified.
  • external-beam radiation therapy, interstitial implantation of radioisotopes/brachytherapy, and palliative radiation therapy in metastatic symptom contexts[3]Standard option (per NCI PDQ)not biomarker-specific; stage I-III localized/locally advanced options and stage IV palliative symptom-control contexts. · Radiation type and intent vary by stage and goals of care. Palliative radiation for symptoms is distinct from definitive radiation for localized disease. Confidence/conflicts: high for NCI PDQ modality listing; no conflict identified.
  • hormonal manipulations / androgen-deprivation approaches[3]Standard option (per NCI PDQ)not biomarker-specific; stage III with or without radiation; stage IV disease. · Hormonal therapy is not chemotherapy, but this queue category is used here for systemic non-targeted medical therapy until a prostate-specific endocrine category exists. Choice of agent and combinations require oncology/urology review. Confidence/conflicts: high for NCI PDQ modality support; category mapping caveat noted. No conflict identified.
  • lutetium Lu 177 vipivotide tetraxetan (Pluvicto)[4]FDA-approvedPSMA-positive disease by appropriate imaging/selection pathway; PSMA-positive mCRPC after androgen receptor pathway inhibitor therapy, when delaying taxane-based chemotherapy is considered appropriate. · This is a radioligand therapy label indication. PSMA positivity, prior therapy, marrow/renal status, radiation-safety logistics, and center capability require specialist review. Confidence/conflicts: high for FDA label; no conflict identified.
  • lutetium Lu 177 vipivotide tetraxetan (Pluvicto)[5]Approvedprostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer; PSMA-positive metastatic castration-resistant prostate cancer after ARPI therapy, either pre-taxane-delay or post-taxane, in the United States. · The legacy 2022 FDA approval page for the original post-taxane indication currently resolves to an FDA page-not-found state, so this finding is anchored to the current DailyMed label rather than the retired page. Radioligand-specific safety issues include radiation exposure precautions, myelosuppression, renal toxicity, embryo-fetal toxicity, and infertility risk. Confidence/conflicts: High for the current U.S. label and 2025 FDA expansion; historical 2022 FDA approval-page link rot noted, but no conflict on current indication.
  • niraparib + abiraterone acetate + prednisone (Akeega + prednisone)[6]FDA-approvedBRCA-mutated metastatic castration-resistant prostate cancer; adult BRCA-mutated metastatic castration-resistant prostate cancer in the United States. · The current AKEEGA label also includes a newer BRCA2-mutated mCSPC indication, but this finding is limited to the mCRPC setting captured in the earlier draft prostate batch. Label warnings and monitoring needs include myelosuppression, hypertension, hypokalemia, hepatotoxicity, and corticosteroid-associated issues. Confidence/conflicts: High for FDA approval and current U.S. label status; no source conflict identified.
  • niraparib and abiraterone acetate (Akeega) plus prednisone[7]FDA-approveddeleterious or suspected deleterious BRCA mutation by FDA-approved test; adult BRCA-mutated metastatic castration-resistant prostate cancer. · Biomarker confirmation is required in the FDA notice. The source does not rank this option against other PARP/androgen-axis combinations. Confidence/conflicts: high for FDA approval notice; no conflict identified.
  • olaparib (Lynparza) with abiraterone and prednisone or prednisolone[8]FDA-approveddeleterious or suspected deleterious BRCA mutation by FDA-approved companion diagnostic; adult BRCA-mutated metastatic castration-resistant prostate cancer. · Biomarker confirmation with an FDA-approved companion diagnostic is part of the FDA statement. This does not imply suitability for people without BRCA-mutated mCRPC or without access to the companion diagnostic. Confidence/conflicts: high for FDA approval notice; no conflict identified.
  • radical prostatectomy[3]Standard option (per NCI PDQ)not biomarker-specific; stage I-III prostate cancer contexts. · Surgical appropriateness depends on stage/risk, anatomy, health status, goals, and multidisciplinary evaluation. NCI PDQ listing is not patient-specific eligibility. Confidence/conflicts: high for NCI PDQ modality listing; no conflict identified.
  • talazoparib + enzalutamide (Talzenna + Xtandi)[9]FDA-approvedhomologous recombination repair gene-mutated metastatic castration-resistant prostate cancer; adult HRR gene-mutated metastatic castration-resistant prostate cancer in the United States. · The FDA approval page summarizes TALAPRO-2 and notes prior systemic therapy for mCRPC was excluded, though prior CYP17 inhibitors or docetaxel for mCSPC were permitted. The TALZENNA label carries major hematologic toxicity and MDS/AML warnings, so this is not a generic PARP option for all-comers. Confidence/conflicts: High for FDA approval and current label wording; no source conflict identified.
  • watchful waiting or active surveillance / active monitoring[3]Standard option (per NCI PDQ)not biomarker-specific; localized stage I-III prostate cancer contexts as listed by NCI PDQ. · Monitoring approaches depend on risk group, life expectancy, symptoms, pathology, PSA kinetics, imaging, and patient preferences. This is an option to discuss, not a recommendation to defer treatment. Confidence/conflicts: high for NCI PDQ modality listing; no conflict identified.

European Union

  • lutetium (177Lu) vipivotide tetraxetan (Pluvicto)[10]EMA authorisedPSMA-positive prostate cancer; progressive PSMA-positive mCRPC after androgen-receptor pathway inhibition and taxane-based chemotherapy in the established EU indication. · EMA central authorisation does not establish national availability. The 2026 withdrawn variation means earlier pre-taxane expansion should not be inferred from the EU label. Confidence/conflicts: high for established EU indication and withdrawn-variation caveat; no conflict identified.
  • lutetium (177Lu) vipivotide tetraxetan (Pluvicto)[11]G-BA benefit assessmentPSMA-positive disease; progressive PSMA-positive mCRPC after AR pathway inhibition and taxane-based chemotherapy. · G-BA English text is a courtesy translation; the German original is legally binding. Benefit-assessment language is not an individual access decision. Confidence/conflicts: high for G-BA/IQWiG indication support; German original legally binding. No conflict identified.
  • lutetium (177Lu) vipivotide tetraxetan (Pluvicto) with androgen-deprivation therapy, with or without androgen receptor pathway inhibition[12]HAS reimbursement opinionPSMA-positive disease; third-line progressive PSMA-positive mCRPC after AR pathway inhibition and taxane-based chemotherapy. · HAS reimbursement opinion does not establish individual eligibility, radioligand-center capacity, or access outside the specified pathway. Confidence/conflicts: high for HAS opinion; no conflict identified.
  • niraparib and abiraterone acetate (Akeega) with prednisone or prednisolone, with androgen-deprivation therapy in the mHSPC indication[13]EMA authorisedBRCA1/2 mutations, germline and/or somatic; metastatic hormone-sensitive prostate cancer with BRCA1/2 mutations; metastatic castration-resistant prostate cancer with BRCA1/2 mutations when chemotherapy is not clinically indicated. · EMA central authorisation does not establish national reimbursement, access, or preference over other PARP/androgen-axis approaches. Biomarker confirmation is required. Confidence/conflicts: high for EMA authorised indications; no conflict identified.
  • niraparib/abiraterone acetate (Akeega) with prednisone or prednisolone[14]HAS reimbursement opinionBRCA1/2 mutations, germline and/or somatic; mCRPC with BRCA1/2 mutations when chemotherapy is not clinically indicated. · HAS notes the place of Akeega relative to olaparib plus abiraterone cannot be specified without comparative data, and reminds clinicians about serious hematologic risk monitoring. This is not a personalized recommendation. Confidence/conflicts: high for HAS opinion; no conflict identified.
  • olaparib (Lynparza) monotherapy[15]EMA authorisedBRCA1/2 mutation, germline and/or somatic; after progression following prior therapy that included a new hormonal agent. · EMA central authorisation does not establish reimbursement or access in each member state. BRCA1/2 mutation confirmation and prior-treatment history are essential. Confidence/conflicts: high for EMA authorised indication; no conflict identified.
  • olaparib (Lynparza) with abiraterone and prednisone or prednisolone[15]EMA authorisedno biomarker restriction stated in the EMA indication for this combination; mCRPC when chemotherapy is not clinically indicated. · Central authorisation does not determine national reimbursement. The source does not rank this combination against other androgen-axis or PARP options. Confidence/conflicts: high for EMA authorised indication; no conflict identified.

United Kingdom

  • active surveillance[16]NICE recommendednot biomarker-specific; CPG 1-3 localised prostate cancer contexts with restrictions by risk group. · Active surveillance is risk-stratified and not recommended by NICE for CPG 4-5. This entry does not imply suitability for an individual patient. Confidence/conflicts: high for NICE recommendation text; no conflict identified.
  • hormone therapy, chemotherapy when spread, supportive symptom care as part of specialist team management[17]Standard option (per NHS)not biomarker-specific; broad treatment/supportive context; chemotherapy if cancer has spread. · NHS public information is broad and not a treatment-selection guideline. It should be paired with NICE, oncologist/urologist, and local pathway details. Confidence/conflicts: medium-high; source is authoritative public information but broad. No conflict identified.
  • lutetium-177 vipivotide tetraxetan (Pluvicto)[18]NICE recommendedPSMA-positive disease; after 2 or more treatments including an AR pathway inhibitor and taxane-based chemotherapy. · Recommendation depends on PSMA positivity, prior-treatment sequence, and the commercial arrangement. It does not establish access in every UK setting or suitability for pre-taxane use. Confidence/conflicts: high for NICE recommendation; no conflict identified.
  • olaparib (Lynparza) with abiraterone and prednisone or prednisolone[19]NICE recommendedno BRCA requirement stated by NICE recommendation; untreated hormone-relapsed metastatic prostate cancer. · NICE appraisal applies to the NHS England context and does not determine devolved/private access. The recommendation is for the specified untreated hormone-relapsed metastatic setting. Confidence/conflicts: high for NICE recommendation; no conflict identified.
  • radical prostatectomy or radical radiotherapy[16]NICE recommendednot biomarker-specific; CPG 3 localised; CPG 4-5 localised and locally advanced prostate cancer when long-term control is likely. · Category is recorded as surgery because radical prostatectomy is one option, but the same NICE cell also supports radical radiotherapy. Choice depends on risk group, anatomy, comorbidity, and patient preferences. Confidence/conflicts: high for NICE recommendation text; no conflict identified.

Japan

  • olaparib (Lynparza) with abiraterone and prednisolone[20]PMDA-approved (Japan)BRCA-mutated; BRCA-mutated castration-resistant prostate cancer with distant metastasis. · Manufacturer announcement is MHLW-attributed but not the current Japanese package insert. Confirm current label, companion diagnostic requirements, reimbursement, and prednisolone wording locally. Confidence/conflicts: medium-high; combination-specific approval is source-backed by manufacturer/MHLW-attributed announcement, with primary-label follow-up needed. No conflict identified.

Russia

Thailand

  • Abiraterone acetate (Zytiga) with prednisone[22]ApprovedNot biomarker-selected; Metastatic CRPC; metastatic high-risk CSPC. · NDI document supports indication text but not reimbursement, formulary access, or center-level availability. The prescribing document states that GnRH analogue treatment should continue unless bilateral orchiectomy has been done. Confidence/conflicts: High for Thai NDI indication text; reimbursement not established.
  • Docetaxel with prednisone or prednisolone[23]ApprovedNot biomarker-selected; Metastatic prostate cancer resistant to hormonal/androgen-dependent control, as described in the Thai product document. · NDI document supports an approved chemotherapy indication, not a full treatment sequence or reimbursement guarantee. Toxicity monitoring, premedication, and fitness for chemotherapy require oncology assessment. Confidence/conflicts: High for Thai NDI indication text; reimbursement and sequencing not established. Primary source is in Thai. English summary pending human review — confirm exact wording with your care team.
  • Enzalutamide (Xtandi)[24]ApprovedNot biomarker-selected; mHSPC; high-risk nmCRPC; chemo-not-yet-indicated mCRPC after ADT; post-docetaxel mCRPC. · NDI prescribing document supports indication text and clinical-use conditions but not reimbursement, hospital formulary availability, or individual eligibility. Continued medical or surgical castration is described in the prescribing document. Confidence/conflicts: High for Thai NDI indication text; reimbursement not established. Primary source is in Thai. English summary pending human review — confirm exact wording with your care team.
  • Enzalutamide (Xtandi)[24]ApprovedNot biomarker-selected; mHSPC; high-risk nmCRPC; chemo-not-yet-indicated mCRPC after ADT; post-docetaxel mCRPC. · NDI prescribing document supports indication text and clinical-use conditions but not reimbursement, hospital formulary availability, or individual eligibility. Continued medical or surgical castration is described in the prescribing document. Confidence/conflicts: High for Thai NDI indication text; reimbursement not established. Primary source is in Thai. English summary pending human review — confirm exact wording with your care team.
  • Niraparib plus abiraterone acetate (Akeega) with prednisone or prednisolone[25]ApprovedBRCA1/2 mutation, germline or somatic; BRCA1/2-mutated mCRPC when chemotherapy is not clinically indicated. · Positive BRCA status must be established before treatment according to the prescribing document. NDI does not establish reimbursement, testing availability, or local access. Confidence/conflicts: High for Thai NDI indication text; reimbursement and BRCA testing access not established.
  • Olaparib (Lynparza) monotherapy or olaparib with abiraterone and prednisone/prednisolone[26]ApprovedHomologous recombination repair (HRR) gene mutations for olaparib monotherapy; no genomic testing required in the source for olaparib plus abiraterone/prednisone use; HRR-mutated mCRPC after prior new hormonal agent for monotherapy; mCRPC when chemotherapy is not clinically indicated for combination use. · NDI document supports indication text, mutation-testing requirements, and prescribing context but not reimbursement or local laboratory availability. HRR testing method and specimen type should be validated locally. Confidence/conflicts: High for Thai NDI indication text; reimbursement and validated local testing access not established.

출처

  1. DailyMed / U.S. National Library of Medicine — official U.S. drug label · official U.S. drug label
  2. DailyMed / U.S. National Library of Medicine — official U.S. drug label · official U.S. drug label
  3. National Cancer Institute (NCI) — national cancer agency evidence summary · national cancer agency evidence summary
  4. U.S. Food and Drug Administration (FDA) — drug label / prescribing information · drug label / prescribing information
  5. DailyMed / U.S. National Library of Medicine — official U.S. drug label · official U.S. drug label
  6. DailyMed / U.S. National Library of Medicine — official U.S. drug label · official U.S. drug label
  7. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  8. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  9. DailyMed / U.S. National Library of Medicine — official U.S. drug label · official U.S. drug label
  10. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  11. Institute for Quality and Efficiency in Health Care (IQWiG) — national HTA dossier assessment project page · national HTA dossier assessment project page
  12. Haute Autorité de Santé (HAS) — national HTA/reimbursement opinion · national HTA/reimbursement opinion
  13. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  14. Haute Autorité de Santé (HAS) — national HTA/reimbursement opinion · national HTA/reimbursement opinion
  15. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  16. National Institute for Health and Care Excellence (NICE) — national guideline · national guideline
  17. NHS — national health service patient information · national health service patient information
  18. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  19. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  20. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review report / olaparib regulatory context · regulator review report / olaparib regulatory context
  21. Russian Society of Clinical Oncology (RUSSCO) / RosOncoWeb — professional society clinical recommendations PDF · professional society clinical recommendations PDF
  22. Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository
  23. Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository
  24. Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository
  25. Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository
  26. Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository

위 내용은 공식 규제·접근 상태일 뿐, 의학적 조언이나 추천이 아니고, 적격성을 판단하지도 않습니다. 어떤 선택지가 적합한지는 환자의 상황과 종양내과 팀에 달려 있습니다. 규제 상태는 바뀔 수 있으니 표시된 출처에서 확인하세요. 임상 세부 내용은 영문이 정본입니다. 최종 확인 2026-06-12.