Can you provide a list of FDA-approved drugs for prostate cancer, including medicines used for earlier and advanced stages?
Quick Answer
There is no single prostate-cancer drug that is appropriate for every stage. Treatment depends on whether cancer is localized, has returned after local treatment, has spread to other parts of the body, remains sensitive to androgen-deprivation therapy, has become castration-resistant, and whether the tumor carries specific genetic or molecular features.
For many men with localized early prostate cancer, medicines are not the primary treatment. Depending on risk, management may involve active surveillance, surgery or radiation. Drug therapy becomes particularly important in higher-risk disease, recurrence and metastatic prostate cancer.
The FDA-approved systemic treatment landscape now includes androgen-deprivation medicines, androgen-receptor pathway inhibitors, chemotherapy, PARP inhibitors for selected molecular subtypes, immunotherapy and radiopharmaceuticals.
The original version of this page listed only a few medicines, including abiraterone, cabazitaxel, degarelix and sipuleucel-T. That list is now substantially outdated. Prostate-cancer treatment has changed considerably, with several new indications and biomarker-directed treatments added in recent years.
Why Prostate Cancer Stage and Biology Matter
Before looking at individual drugs, it helps to understand that doctors do not choose prostate-cancer medication simply from a list of FDA approvals.
Treatment can depend on:
- whether the cancer is localized or metastatic;
- whether it is still sensitive to androgen deprivation;
- whether it has become castration-resistant;
- previous surgery, radiation, hormone therapy or chemotherapy;
- PSA behavior and imaging results;
- symptoms and sites of metastasis;
- overall health and other medical conditions; and
- tumor biomarkers such as BRCA1/2 or other homologous recombination repair (HRR) alterations and PSMA expression.
For background on how disease extent is described, see our guide to prostate cancer stages.
What About Early or Localized Prostate Cancer?
This is one of the most important corrections to the old page: early prostate cancer does not automatically require a cancer drug.
For localized disease, options may include active surveillance for selected lower-risk cancers, radical prostatectomy, radiation therapy, or combinations of radiation and androgen-deprivation therapy for selected higher-risk disease.
Therefore, a list of medications should not imply that newly diagnosed localized prostate cancer is routinely treated with tablets, injections or chemotherapy alone.
Major FDA-Approved Drug Groups for Prostate Cancer
| Drug group | Examples | Where they may be used |
|---|---|---|
| Androgen-deprivation therapy (ADT) | Leuprolide, goserelin, triptorelin, histrelin; degarelix; relugolix (Orgovyx) | Used to suppress testosterone in multiple settings, particularly advanced/metastatic disease and in combination with other therapies. |
| Androgen-receptor pathway therapy | Abiraterone (Zytiga), enzalutamide (Xtandi), apalutamide (Erleada), darolutamide (Nubeqa) | Used in several hormone-sensitive and castration-resistant settings depending on the specific drug and FDA indication. |
| Chemotherapy | Docetaxel, cabazitaxel (Jevtana) | Used in selected metastatic hormone-sensitive or metastatic castration-resistant disease. |
| PARP inhibitors / biomarker-directed therapy | Olaparib (Lynparza), rucaparib (Rubraca), talazoparib (Talzenna), niraparib + abiraterone (Akeega) | Used for selected metastatic cancers with BRCA or other qualifying HRR alterations; exact biomarker and treatment-history requirements differ by product. |
| Immunotherapy | Sipuleucel-T (Provenge) | For selected men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. |
| Radiopharmaceutical therapy | Radium-223 (Xofigo), lutetium Lu 177 vipivotide tetraxetan (Pluvicto) | Used in specific metastatic settings. Pluvicto requires PSMA-positive disease and its FDA indications have expanded. |
Androgen-Deprivation Therapy (ADT)
Prostate cancer cells commonly depend on androgen signaling. Androgen-deprivation therapy lowers testosterone or blocks the hormonal signals that stimulate prostate-cancer growth.
GnRH Agonists
Examples include leuprolide, goserelin, triptorelin and histrelin. These medicines suppress testicular testosterone production after an initial hormonal response.
GnRH Antagonists
Degarelix is an injectable GnRH antagonist. Relugolix (Orgovyx) is an oral GnRH receptor antagonist FDA approved for adults with advanced prostate cancer.
Unlike GnRH agonists, antagonists suppress testosterone without the same initial testosterone surge or “flare.”
ADT can cause important long-term effects including hot flashes, sexual dysfunction, loss of bone density, changes in body composition and metabolic effects. These need ongoing medical management.
Abiraterone (Zytiga)
Abiraterone acetate inhibits CYP17, an enzyme involved in androgen production. It is generally administered with corticosteroid therapy such as prednisone.
Abiraterone has FDA-approved roles in metastatic prostate cancer, including metastatic castration-resistant prostate cancer and metastatic high-risk castration-sensitive prostate cancer.
Patients require monitoring because treatment can affect blood pressure, potassium levels, fluid balance and liver function.
Enzalutamide (Xtandi)
Enzalutamide is an androgen-receptor inhibitor with several prostate-cancer indications.
Importantly, its role is no longer limited to advanced metastatic disease. In 2023, the FDA approved enzalutamide for non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis. This may be used with leuprolide or, for selected patients, as enzalutamide monotherapy.
Apalutamide (Erleada)
Apalutamide is another androgen-receptor inhibitor. It is FDA approved in settings including non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.
Darolutamide (Nubeqa)
Darolutamide is an androgen-receptor inhibitor used in prostate cancer.
It has FDA-approved indications for non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer. In June 2025, the FDA expanded its metastatic castration-sensitive indication so that darolutamide can be used without requiring docetaxel as part of the regimen.
Docetaxel and Cabazitaxel Chemotherapy
Docetaxel
Docetaxel is a taxane chemotherapy drug used in prostate cancer. It has an established role in metastatic castration-resistant disease and may also be incorporated into treatment of selected men with metastatic hormone-sensitive disease.
Cabazitaxel (Jevtana)
Cabazitaxel is another taxane chemotherapy used for metastatic castration-resistant prostate cancer after prior docetaxel-containing treatment.
Because taxane chemotherapy can cause serious adverse effects, including bone-marrow suppression and infection risk, treatment requires oncology supervision and blood-count monitoring.
PARP Inhibitors: Why Genetic Testing Now Matters
One of the largest changes since the original version of this article is the arrival of biomarker-directed treatment.
Some prostate cancers contain alterations in genes responsible for DNA repair. These tumors may be susceptible to PARP inhibition.
Olaparib (Lynparza)
Olaparib has FDA-approved uses in selected metastatic castration-resistant prostate cancers with qualifying homologous recombination repair alterations. It is also approved with abiraterone and prednisone or prednisolone for BRCA-mutated metastatic castration-resistant prostate cancer.
Rucaparib (Rubraca)
In December 2025, the FDA granted regular approval to rucaparib for adults with deleterious BRCA-mutated metastatic castration-resistant prostate cancer previously treated with an androgen-receptor-directed therapy. An FDA-approved companion diagnostic is used for patient selection.
Talazoparib (Talzenna) + Enzalutamide
Talazoparib in combination with enzalutamide is FDA approved for HRR gene-mutated metastatic castration-resistant prostate cancer.
Niraparib + Abiraterone (Akeega)
Akeega combines niraparib with abiraterone acetate. It is approved with prednisone for selected BRCA-mutated metastatic castration-resistant prostate cancer.
In December 2025, the FDA also approved Akeega with prednisone for adults with BRCA2-mutated metastatic castration-sensitive prostate cancer, based on an FDA-approved test.
Sipuleucel-T (Provenge)
Sipuleucel-T is a cellular immunotherapy, sometimes described as a therapeutic cancer vaccine.
It is designed to stimulate an immune response against prostate cancer and is used for selected men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
It is a treatment for existing cancer, not a vaccine given to healthy men to prevent prostate cancer.
Radium-223 (Xofigo)
Radium-223 dichloride is a radiopharmaceutical that targets areas of increased bone turnover.
It is used in selected men with castration-resistant prostate cancer that has spread to bone and should be considered according to its specific FDA indication and the patient’s pattern of metastatic disease.
Pluvicto: An Important Newer PSMA-Targeted Treatment
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a radioligand therapy that targets prostate-specific membrane antigen (PSMA).
Its role has expanded considerably since its original 2022 approval.
In March 2025, the FDA expanded Pluvicto for adults with PSMA-positive metastatic castration-resistant prostate cancer who had received androgen-receptor pathway inhibitor therapy and were considered appropriate to delay taxane chemotherapy.
Then, on July 31, 2026, the FDA approved Pluvicto in combination with androgen-receptor pathway inhibitor therapy for adults with PSMA-positive metastatic androgen pathway modulation-naïve or sensitive prostate cancer, previously referred to as metastatic hormone-sensitive prostate cancer.
Patients must be selected using an approved PSMA PET imaging product based on PSMA expression.
Are Older Antiandrogens Still FDA Approved?
Yes. Older androgen-receptor blockers such as bicalutamide, flutamide and nilutamide have FDA-approved prostate-cancer indications.
However, modern treatment strategies increasingly use newer androgen-receptor pathway inhibitors in many settings because treatment recommendations evolve as stronger clinical evidence becomes available.
An FDA approval and a current preferred guideline treatment are therefore not necessarily the same thing.
Is There One Complete Drug List for Every Patient?
No. A simple alphabetical list can actually be misleading because the important question is not merely, “Is this drug FDA approved for prostate cancer?” but:
- FDA approved for which disease state?
- before or after which previous treatment?
- with or without ongoing ADT?
- does the patient need a particular BRCA/HRR mutation?
- does the tumor need to be PSMA positive?
- is chemotherapy appropriate?
- are there bone-only or visceral metastases?
- what other health conditions affect treatment safety?
That is why prostate-cancer treatment should be planned with a urologist and medical/radiation oncology team rather than selected from an online medication list.
What Should a Patient Ask Before Starting a Prostate Cancer Drug?
Useful questions include:
- What exact stage and disease state do I have?
- Is my cancer hormone-sensitive or castration-resistant?
- Do I need tumor or germline genetic testing?
- Should my cancer be tested for BRCA or other HRR alterations?
- Do I need PSMA PET imaging?
- What benefit is expected from this treatment?
- What are the major side effects and monitoring requirements?
- Will I continue androgen-deprivation therapy?
- What alternatives are available?
The FDA-approved prostate-cancer treatment landscape is now far broader than the four medicines listed on the original version of this page. Modern treatment includes hormonal therapy, androgen-receptor pathway inhibitors, chemotherapy, immunotherapy, PARP inhibitors selected by tumor genetics, and PSMA-targeted radiopharmaceutical treatment.
For an individual patient, however, the most important step is not choosing a drug from this list. It is first establishing the exact disease state, previous treatment history and relevant biomarkers. Those details determine which FDA-approved options are actually appropriate.
Dr. Albana Greca, MD, MMedSc
Family Physician / General Practitioner
Founder & Lead Medical Author, Prostate Treatment Options
Medical References
U.S. Food and Drug Administration. Prostate Cancer: Symptoms, Tests and Treatments.
U.S. Food and Drug Administration. FDA approval notifications for prostate-cancer therapies, including enzalutamide, darolutamide, PARP-inhibitor combinations, rucaparib and lutetium Lu 177 vipivotide tetraxetan.
National Cancer Institute. Hormone Therapy for Prostate Cancer.
National Cancer Institute. Prostate Cancer Treatment (PDQ).
Last evidence update: September 2026.