A Post-Authorization Safety Study (PASS) to characterize the risk of secondary primary malignancy including MDS/AML among metastatic prostate cancer patients exposed to AKEEGA (niraparib/abiraterone acetate fixed-dose combination tablet) plus Prednisone/Prednisolone

Study identification

• EU PAS number:
  EUPAS1000000323
• Study ID:
  1000000323
• Official title and acronym:
  A Post-Authorization Safety Study (PASS) to characterize the risk of secondary primary malignancy including MDS/AML among metastatic prostate cancer patients exposed to AKEEGA (niraparib/abiraterone acetate fixed-dose combination tablet) plus Prednisone/Prednisolone
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  The primary objective is to estimate the incidence of myelodysplastic syndrome / acute myeloid leukemia and other second primary malignancies among patients exposed to AKEEGA and other BRCA1/2 mutated patients exposed to AAP or other neoadjuvant hormonal therapies (NHTs) indicated for metastatic castrate resistant prostate cancer (mCRPC).
• Study status:
  Planned

Research institutions and networks

Institutions

Johnson & Johnson

Study timelines

Date when funding contract was signed

Planned: 17/07/2024

Actual: 17/07/2024

Study start date

Planned: 24/04/2025

Date of final study report

Planned: 31/12/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Johnson and Johnson

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)