Metastatic prostate cancer, or cancer that has spread beyond the lymph nodes, affects 8% of patients with prostate cancer and is associated with poorer
5-year survival rates (38%)2

Percentages of US patients with castration-resistant, castration-sensitive, HRR-mutated, and BRCA-mutated prostate cancer
Percentages of US patients with castration-resistant, castration-sensitive, HRR-mutated, and BRCA-mutated prostate cancer

~80%-90% of patients
with prostate cancer
remain castration sensitive within 5 years of follow-up
from diagnosis3*

~10%-20% of patients with prostate cancer progress to castration-resistant disease within 5 years of follow-up3*

Percentages of US patients with castration-resistant, castration-sensitive, HRR-mutated, and BRCA-mutated prostate cancer
Percentages of US patients with castration-resistant, castration-sensitive, HRR-mutated, and BRCA-mutated prostate cancer

~39% of mCRPC patients in the US are positive for HRR mutations4†

~20% of mCRPC patients in the US are positive for BRCA mutations specifically4†

*Percentages are from an observation based on a systematic review of 5 studies that included 70,086 patients observed for up to 12 years.

†Based on a global survey conducted in 2020 of mCRPC patients with BRCA or other HRR mutations. Percentages and ns shown are from the US population.

Patients with BRCA1/2 mutations are at risk for more aggressive disease and poorer outcomes5

Streamline the path to care now for targeted treatment later

Earlier genetic testing provides more control over future treatment options

Genetic testing visual

Guidelines recommend conducting germline genetic testing for advanced prostate cancer patients at the time of initial diagnosis6,7


  • If the patient has:
    • Positive family history of prostate cancer
    • Ashkenazi Jewish ancestry
    • Family or personal history of breast cancer
    • High-risk, very high-risk, regional, or metastatic prostate cancer regardless of family history
  • At the time of metastatic diagnosis, conduct tumor testing for HRR mutations in patients with metastatic prostate cancer if not previously performed, with consideration of re-evaluation upon progression. Also consider6:
    • Tumor mutational burden testing
    • Tumor testing for microsatellite instability (MSI) or deficient mismatch repair (dMMR)
    • Multigene molecular testing
  • If the patient has:
    • Positive family history of prostate cancer
    • Ashkenazi Jewish ancestry
    • Family or personal history of breast cancer
    • High-risk, very high-risk, regional, or metastatic prostate cancer regardless of family history
  • At the time of metastatic diagnosis, conduct tumor testing for HRR mutations in patients with metastatic prostate cancer if not previously performed, with consideration of re-evaluation upon progression. Also consider6:
    • Tumor mutational burden testing
    • Tumor testing for microsatellite instability (MSI) or deficient mismatch repair (dMMR)
    • Multigene molecular testing

Select patients for treatment with PARPis based on the presence of a deleterious BRCA
 mutation (germline and/or somatic)8-11

  • Negative result from a plasma specimen does not mean that the patient’s tumor is negative for BRCA mutations8
  • If the plasma specimen has a negative result, consider performing further genomic testing using tumor specimens as clinically indicated8

Multiple genetic tests are commercially available to help you assess BRCA mutations in patients with prostate cancer. 

In the pre-docetaxel setting, rucaparib is a preferred option for patients with BRCA1 or BRCA2 mutations12 

National Comprehensive Cancer Network® (NCCN®) makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.

LEARN MORE ABOUT THE FLEXIBILITY RUBRACA OFFERS ALONG THE mCRPC JOURNEY

EXPLORE NOW

BRCA, BReast CAncer gene; HRR, homologous recombination repair; mCRPC, metastatic castration-resistant prostate cancer; PARPi, poly (adenosine diphosphate-ribose) polymerase inhibitor. 

REFERENCES: 1. Key statistics for prostate cancer. American Cancer Society. Accessed September 10, 2025. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html 2. Cancer stat facts: prostate cancer. National Cancer Institute Surveillance, Epidemiology, and End Results Program. https://seer.cancer.gov/statfacts/html/prost.html 3. Kirby M, Hirst C, Crawford ED. Characterising the castration-resistant prostate cancer population: a systematic review. Int J Clin Pract. 2011;65(11):1180-1192. 4. Leith A, Ribbands A, Kim J, et al. Real-world homologous recombination repair mutation testing in metastatic castration-resistant prostate cancer in the USA, Europe and Japan. Future Oncol. 2022;18(8):937-951. 5. Na R, Zheng SL, Han M, et al. Germline mutations in ATM and BRCA1/2 distinguish risk for lethal and indolent prostate cancer and are associated with early age at death. Eur Urol. 2017;71(5):740-747. 6. Tuffaha H, Edmunds K, Fairbairn D, et al. Clinical guidelines for genetic testing in prostate cancer: a scoping review. Prostate Cancer Prostatic Dis. 2024;27(3):594-603. 7. Xu J, Lu J, Gielzak M, et al. Germline testing for prostate cancer patients: evidence-based evaluation of genes recommended by NCCN guidelines. Prostate. 2025;85(11):1087-1095. 8. RUBRACA (rucaparib). Prescribing Information. pharmaand GmbH. 2025. 9. Lynparza (olaparib). Prescribing Information. AstraZeneca Pharmaceuticals LP. 2025. 10. Akeega (niraparib and abiraterone acetate). Prescribing Information. Janssen Biotech, Inc. 2024. 11. Talzenna (talazoparib). Prescribing Information. Pfizer Inc. 2025 12. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.2.2026. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed October 9, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Tap for safety information

 

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

RUBRACA® (rucaparib) is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/
or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA.

SELECT IMPORTANT SAFETY INFORMATION

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with RUBRACA, and are potentially fatal adverse reactions. In 2141 treated patients with ovarian and prostate cancer, MDS/AML occurred in 34 patients (1.6%), including those in long term follow-up. Of these, 14 occurred during treatment or during the 28-day safety follow-up (0.7%).

The duration of RUBRACA treatment prior to the diagnosis of MDS/AML ranged from < 2 months to approximately 72 months. The cases were typical of secondary MDS/
cancer therapy-related AML; in all cases, patients had received previous platinum-containing chemotherapy regimens and/
or other DNA damaging agents.

In ARIEL3, of patients with ovarian cancer associated with a germline and/or somatic BRCA mutation who were treated with RUBRACA, MDS/AML occurred in 9 out of 129 (7%) patients treated with RUBRACA and 4 out of 66 (6%) patients treated with placebo. The duration of therapy with RUBRACA in patients who developed secondary MDS/cancer therapy-related AML varied from 1.2 to 4.7 years.

In TRITON3, MDS/AML occurred in 2 out of 201 patients (1%) with a BRCA mutation treated with RUBRACA. The duration of therapy with RUBRACA in patients who developed secondary MDS/cancer therapy-related AML varied from 1.4 to 2.3 years.

Do not start RUBRACA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities
(> 4 weeks), interrupt RUBRACA or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after
4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics.

If MDS/AML is confirmed, discontinue RUBRACA.

Based on findings from genetic toxicity and animal reproduction studies, RUBRACA can cause fetal harm. Advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of RUBRACA. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of RUBRACA.

Most common adverse reactions of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON3 (≥10%, Grade 1-4) were fatigue/asthenia (61%), musculoskeletal pain (53%), nausea (51%), decreased appetite (34%), diarrhea (31%), constipation (31%), vomiting (25%), dyspnea (19%), dysgeusia (18%), edema (18%), abdominal pain (17%), dizziness (16%), weight decreased (16%), rash (13%), headache (12%), peripheral neuropathy (12%), photosensitivity reaction (12%), and urinary tract infection (10%).

Most common select laboratory abnormalities of patients with BRCA-mutated mCRPC treated with RUBRACA
in TRITON3 (≥ 25%, Grade 1-4) were increased ALT (68%), decreased neutrophils
(67%), decreased phosphate (64%), decreased hemoglobin (60%), increased AST (59%), increased creatinine (56%), increased glucose (45%), decreased lymphocytes (43%), decreased sodium (35%), decreased platelets (34%), and increased calcium (29%).

Most common adverse reactions of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), decreased appetite (28%), rash (27%), constipation (27%), vomiting (22%), and diarrhea (20%).

Most common laboratory abnormalities of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON2 (≥ 35%; Grade 1-4) were increased ALT (69%), decreased leukocytes (69%), decreased phosphate (68%), decreased absolute neutrophil count (62%), decreased hemoglobin (59%), increased alkaline phosphatase (44%), increased creatinine (43%), decreased lymphocytes (42%), increased triglycerides (42%), decreased platelets (40%), and decreased sodium (38%).

Concomitant administration of RUBRACA with CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates can increase the systemic exposure of these substrates, which may increase the frequency or severity of adverse reactions of these substrates. If concomitant administration is unavoidable between RUBRACA and substrates of these enzymes where minimal concentration changes may lead to serious adverse reactions, decrease the substrate dosage in accordance with the approved prescribing information.

If concomitant administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing the frequency of international normalized ratio (INR) monitoring.

Full Prescribing Information available at: https://www.rubracahcp.com.

For medical information inquiries within the U.S., contact pharma& at medinfo.us@pharmaand.com.

You may report adverse events to the FDA at 1-800-FDA-1088 or www.fda.gov/
medwatch.

Alternatively, to report an adverse event or reaction, contact pharma& at pv@pharmaand.com.

To report a product complaint, contact pharma& at complaints@pharmaand.com.

Please see full Prescribing Information for RUBRACA.

EXPANDED INDICATION

NOW APPROVED FOR USE 
BEFORE OR AFTER CHEMOTHERAPY

for the treatment of BRCA-mutated mCRPC1

  • ⁨⁨Backed by new clinical data from the Phase 3 trial, TRITON3
  • The first and only PARPi studied head-to-head with chemotherapy2
  • Can be used after ANY ARPI

Learn more about the updated indication in the full Prescribing Information

View Updated Prescribing Information

ARPI, androgen receptor pathway inhibitor; BRCA, BReast CAncer gene; mCRPC, metastatic castration-resistant prostate cancer;

PARPi, poly (adenosine diphosphate-ribose) polymerase inhibitor.

REFERENCES: 1. RUBRACA (rucaparib). Prescribing Information. pharmaand GmbH. 2025. 2. Fizazi K, Piulats JM, Reaume MN, et al. Rucaparib or physician’s choice in metastatic prostate cancer. N Engl J Med. 2023;388(8):719-732.

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