^
    6d
    HARMONY: Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations (clinicaltrials.gov)
    P2, N=64, Not yet recruiting, Qian Qin
    New P2 trial • Metastases
    |
    docetaxel • Zejula (niraparib) • abiraterone acetate • Akeega (abiraterone/niraparib)
    1m
    LUNAAR: 177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer (clinicaltrials.gov)
    P1/2, N=30, Not yet recruiting, Rohan Garje
    New P1/2 trial • Metastases
    |
    Zejula (niraparib) • abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Akeega (abiraterone/niraparib)
    2ms
    STAMPEDE2: A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer (clinicaltrials.gov)
    P3, N=8000, Not yet recruiting, University College, London
    New P3 trial • Metastases
    |
    docetaxel • Zejula (niraparib) • Xtandi (enzalutamide capsule) • abiraterone acetate • Erleada (apalutamide) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Akeega (abiraterone/niraparib)
    9ms
    U.S. Food and Drug Administration (FDA) Approves FoundationOne CDx as a Companion Diagnostic for Janssen’s AKEEGA (niraparib and abiraterone acetate Dual Action Tablet) for Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer (Businesswire)
    "Foundation Medicine Inc., today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne® CDx to be used as a companion diagnostic for Janssen Biotech, Inc. (Janssen’s) AKEEGA™ (niraparib and abiraterone acetate Dual Action Tablet), which was approved by the FDA for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC)."
    FDA event
    |
    FoundationOne® CDx
    |
    Akeega (abiraterone/niraparib)
    10ms
    CJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations (clinicaltrials.gov)
    P2, N=30, Recruiting, Mayo Clinic | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    SPOP (Speckle Type BTB/POZ Protein)
    |
    SPOP mutation
    |
    Zejula (niraparib) • abiraterone acetate • Akeega (abiraterone/niraparib)
    1year
    CJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Mayo Clinic | Initiation date: Mar 2023 --> Jun 2023
    Trial initiation date • Metastases
    |
    SPOP (Speckle Type BTB/POZ Protein)
    |
    SPOP mutation
    |
    Zejula (niraparib) • abiraterone acetate • Akeega (abiraterone/niraparib)
    over1year
    CJNJ-67652000 and Prednisone for the Treatment of Men With Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Mayo Clinic
    New P2 trial • Metastases
    |
    SPOP (Speckle Type BTB/POZ Protein)
    |
    SPOP mutation
    |
    Zejula (niraparib) • abiraterone acetate • Akeega (abiraterone/niraparib)