# Prostate cancer

The EU has approved 28 indications of 12 drugs in prostate cancer. 4 of them need a biomarker result: BRCA1/2 (3) and PSMA (1). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

## Approved indications

### BRCA1/2 mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Niraparib + abiraterone](https://oncolabels.com/drugs/niraparib-abiraterone) (Akeega) | Germline and/or somatic BRCA 1/2 mutations | + prednisone or prednisolone | 1st line, metastatic | Castration-resistant only; Chemotherapy is not clinically indicated |
| [Olaparib](https://oncolabels.com/drugs/olaparib) (Lynparza) | BRCA1/2 mutation (germline and/or somatic) | Monotherapy | 2nd line, metastatic | Castration-resistant only; After prior therapy that included a new hormonal agent; Castration-resistant |
| [Niraparib + abiraterone](https://oncolabels.com/drugs/niraparib-abiraterone) (Akeega) | Germline and/or somatic BRCA 1/2 mutations | + prednisone or prednisolone and androgen deprivation therapy (ADT) | Metastatic | Hormone-sensitive only |

### PSMA-positive

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Lutetium (177Lu) vipivotide tetraxetan](https://oncolabels.com/drugs/lutetium-177lu-vipivotide-tetraxetan) (Pluvicto) | PSMA-positive | + androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition | 3rd line+, metastatic | Castration-resistant only; After AR pathway inhibition and taxane-based chemotherapy; Progressive disease |

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Degarelix](https://oncolabels.com/drugs/degarelix) (Firmagon) | None | Monotherapy | Neoadjuvant | High-risk localised or locally advanced; hormone-dependent disease |
| [Abiraterone](https://oncolabels.com/drugs/abiraterone) (Zytiga, Abiraterone Krka) | None | + prednisone or prednisolone | 1st line, metastatic | Castration-resistant only; Failure of androgen deprivation therapy; Asymptomatic or mildly symptomatic; chemotherapy is not yet clinically indicated |
| [Abiraterone](https://oncolabels.com/drugs/abiraterone) (Zytiga, Abiraterone Krka) | None | + prednisone or prednisolone, and androgen deprivation therapy (ADT) | 1st line, metastatic | Hormone-sensitive only; Newly diagnosed; high risk |
| [Enzalutamide](https://oncolabels.com/drugs/enzalutamide) (Xtandi) | None | Monotherapy | 1st line, metastatic | Castration-resistant only; Failure of androgen deprivation therapy; Asymptomatic or mildly symptomatic; chemotherapy is not yet clinically indicated |
| [Olaparib](https://oncolabels.com/drugs/olaparib) (Lynparza) | None | + abiraterone and prednisone or prednisolone | 1st line, metastatic | Castration-resistant only; Chemotherapy is not clinically indicated; castration-resistant Ambiguous in the label (line of therapy): check the SmPC. |
| [Talazoparib](https://oncolabels.com/drugs/talazoparib) (Talzenna) | None | + enzalutamide | 1st line, metastatic | Castration-resistant only; Chemotherapy is not clinically indicated |
| [Abiraterone](https://oncolabels.com/drugs/abiraterone) (Zytiga, Abiraterone Krka) | None | + prednisone or prednisolone | 2nd line, metastatic | Castration-resistant only; Progressed on or after a docetaxel-based chemotherapy regimen |
| [Enzalutamide](https://oncolabels.com/drugs/enzalutamide) (Xtandi) | None | Monotherapy | 2nd line, metastatic | Castration-resistant only; Progressed on or after docetaxel therapy |
| [Apalutamide](https://oncolabels.com/drugs/apalutamide) (Erleada) | None | + androgen deprivation therapy (ADT) | Metastatic | Hormone-sensitive only |
| [Apalutamide](https://oncolabels.com/drugs/apalutamide) (Erleada) | None | Monotherapy | Locally advanced | Castration-resistant only; High risk of developing metastatic disease |
| [Darolutamide](https://oncolabels.com/drugs/darolutamide) (Nubeqa) | None | + androgen deprivation therapy | Metastatic | Hormone-sensitive only |
| [Darolutamide](https://oncolabels.com/drugs/darolutamide) (Nubeqa) | None | + docetaxel and androgen deprivation therapy | Metastatic | Hormone-sensitive only |
| [Darolutamide](https://oncolabels.com/drugs/darolutamide) (Nubeqa) | None | Monotherapy | Locally advanced | Castration-resistant only; High risk of developing metastatic disease |
| [Degarelix](https://oncolabels.com/drugs/degarelix) (Firmagon) | None | + radiotherapy | Any line | High-risk localised or locally advanced; hormone-dependent disease |
| [Degarelix](https://oncolabels.com/drugs/degarelix) (Firmagon) | None | Monotherapy | Advanced | Hormone-dependent disease |
| [Enzalutamide](https://oncolabels.com/drugs/enzalutamide) (Xtandi) | None | + androgen deprivation therapy | Locally advanced | Hormone-sensitive only; High-risk biochemical recurrent (BCR); unsuitable for salvage-radiotherapy |
| [Enzalutamide](https://oncolabels.com/drugs/enzalutamide) (Xtandi) | None | + androgen deprivation therapy | Metastatic | Hormone-sensitive only |
| [Enzalutamide](https://oncolabels.com/drugs/enzalutamide) (Xtandi) | None | Monotherapy | Locally advanced | Hormone-sensitive only; High-risk biochemical recurrent (BCR); unsuitable for salvage-radiotherapy |
| [Enzalutamide](https://oncolabels.com/drugs/enzalutamide) (Xtandi) | None | Monotherapy | Locally advanced | Castration-resistant only; High-risk |
| [Leuprorelin](https://oncolabels.com/drugs/leuprorelin) (Camcevi) | None | + radiotherapy | Any line | High-risk localised or locally advanced; hormone dependent |
| [Leuprorelin](https://oncolabels.com/drugs/leuprorelin) (Camcevi) | None | Monotherapy | Advanced | Hormone dependent |
| [Radium Ra223 dichloride](https://oncolabels.com/drugs/radium-ra223-dichloride) (Xofigo) | None | + LHRH analogue | Metastatic | Castration-resistant only; In progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment; Symptomatic bone metastases; no known visceral metastases |
| [Radium Ra223 dichloride](https://oncolabels.com/drugs/radium-ra223-dichloride) (Xofigo) | None | Monotherapy | Metastatic | Castration-resistant only; In progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment; Symptomatic bone metastases; no known visceral metastases |
| [Relugolix](https://oncolabels.com/drugs/relugolix) (Orgovyx) | None | Monotherapy | Advanced | Hormone-sensitive |

## Tumour-agnostic approvals

Approved for any solid tumour that carries the alteration, wherever the tumour started.

### EpCAM

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Catumaxomab](https://oncolabels.com/drugs/catumaxomab) (Korjuny) | EpCAM-positive | Monotherapy | 2nd line | Malignant ascites; not eligible for further systemic anticancer therapy Ambiguous in the label (tumour site, line of therapy): check the SmPC. |

### HER2

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2-positive (IHC 3+) | Monotherapy | 2nd line, advanced | After prior treatment; No satisfactory treatment options |

### NTRK fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Entrectinib](https://oncolabels.com/drugs/entrectinib) (Rozlytrek) | NTRK fusion | Monotherapy | Any line | No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Larotrectinib](https://oncolabels.com/drugs/larotrectinib) (Vitrakvi) | NTRK fusion | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Repotrectinib](https://oncolabels.com/drugs/repotrectinib) (Augtyro) | NTRK fusion | Monotherapy | Advanced | Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older |

### RET fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Selpercatinib](https://oncolabels.com/drugs/selpercatinib) (Retsevmo) | RET fusion | Monotherapy | Advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older |

## Label wording

- **Degarelix** (Firmagon), Prostate cancer, advanced: “for treatment of adult male patients with advanced hormone-dependent prostate cancer.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/firmagon-epar-product-information_en.pdf)
- **Degarelix** (Firmagon), Prostate cancer, any line: “for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/firmagon-epar-product-information_en.pdf)
- **Degarelix** (Firmagon), Prostate cancer, neoadjuvant: “as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/firmagon-epar-product-information_en.pdf)
- **Radium Ra223 dichloride** (Xofigo), Prostate cancer, metastatic: “Xofigo monotherapy or in combination with luteinising hormone releasing hormone (LHRH) analogue is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastases, in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment (see section 4.4).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xofigo-epar-product-information_en.pdf)
- **Radium Ra223 dichloride** (Xofigo), Prostate cancer, metastatic: “Xofigo monotherapy or in combination with luteinising hormone releasing hormone (LHRH) analogue is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastases, in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment (see section 4.4).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xofigo-epar-product-information_en.pdf)
- **Enzalutamide** (Xtandi), Prostate cancer, locally advanced: “as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xtandi-epar-product-information_en.pdf)
- **Enzalutamide** (Xtandi), Prostate cancer, locally advanced: “as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xtandi-epar-product-information_en.pdf)
- **Enzalutamide** (Xtandi), Prostate cancer, metastatic: “in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xtandi-epar-product-information_en.pdf)
- **Enzalutamide** (Xtandi), Prostate cancer, locally advanced: “for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xtandi-epar-product-information_en.pdf)
- **Enzalutamide** (Xtandi), Prostate cancer, 1st line, metastatic: “for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xtandi-epar-product-information_en.pdf)
- **Enzalutamide** (Xtandi), Prostate cancer, 2nd line, metastatic: “for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xtandi-epar-product-information_en.pdf)
- **Relugolix** (Orgovyx), Prostate cancer, advanced: “Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/orgovyx-epar-product-information_en.pdf)
- **Leuprorelin** (Camcevi), Prostate cancer, advanced: “CAMCEVI is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/camcevi-epar-product-information_en.pdf)
- **Leuprorelin** (Camcevi), Prostate cancer, any line: “CAMCEVI is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/camcevi-epar-product-information_en.pdf)
- **Niraparib + abiraterone** (Akeega), Prostate cancer, metastatic: “in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline and/or somatic).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/akeega-epar-product-information_en.pdf)
- **Niraparib + abiraterone** (Akeega), Prostate cancer, 1st line, metastatic: “for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA 1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/akeega-epar-product-information_en.pdf)
- **Olaparib** (Lynparza), Prostate cancer, 2nd line, metastatic: “as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf)
- **Olaparib** (Lynparza), Prostate cancer, 1st line, metastatic: “in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf)
- **Lutetium (177Lu) vipivotide tetraxetan** (Pluvicto), Prostate cancer, 3rd line+, metastatic: “Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane-based chemotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/pluvicto-epar-product-information_en.pdf)
- **Apalutamide** (Erleada), Prostate cancer, locally advanced: “in adult men for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erleada-epar-product-information_en.pdf)
- **Apalutamide** (Erleada), Prostate cancer, metastatic: “in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erleada-epar-product-information_en.pdf)
- **Abiraterone** (Zytiga, Abiraterone Krka), Prostate cancer, 1st line, metastatic: “the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zytiga-epar-product-information_en.pdf)
- **Abiraterone** (Zytiga, Abiraterone Krka), Prostate cancer, 1st line, metastatic: “the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zytiga-epar-product-information_en.pdf)
- **Abiraterone** (Zytiga, Abiraterone Krka), Prostate cancer, 2nd line, metastatic: “the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zytiga-epar-product-information_en.pdf)
- **Talazoparib** (Talzenna), Prostate cancer, 1st line, metastatic: “Talzenna is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/talzenna-epar-product-information_en.pdf)
- **Darolutamide** (Nubeqa), Prostate cancer, locally advanced: “- non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/nubeqa-epar-product-information_en.pdf)
- **Darolutamide** (Nubeqa), Prostate cancer, metastatic: “- metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/nubeqa-epar-product-information_en.pdf)
- **Darolutamide** (Nubeqa), Prostate cancer, metastatic: “- metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/nubeqa-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/tumours/prostate-cancer