^
    2ms
    LUNAAR: 177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer (clinicaltrials.gov)
    P1/2, N=0, Withdrawn, Baptist Health South Florida | N=30 --> 0 | Trial completion date: Jul 2028 --> Oct 2028 | Initiation date: Jul 2024 --> Oct 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jul 2026 --> Oct 2026
    Enrollment change • Trial completion date • Trial initiation date • Trial withdrawal • Trial primary completion date • Metastases
    |
    Zejula (niraparib) • abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Akeega (abiraterone/niraparib)
    3ms
    STAMPEDE2: A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer (clinicaltrials.gov)
    P3, N=8000, Recruiting, University College, London | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    docetaxel • Zejula (niraparib) • Xtandi (enzalutamide capsule) • abiraterone acetate • Erleada (apalutamide) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Akeega (abiraterone/niraparib)
    5ms
    U.S. Food and Drug Administration (FDA) Approves FoundationOne Liquid CDx as a Companion Diagnostic for AKEEGA (niraparib and abiraterone acetate) 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 Liquid CDx to be used as a companion diagnostic for AKEEGA (niraparib and abiraterone acetate) from Janssen Biotech, Inc, a Johnson & Johnson company, the first and only FDA-approved dual-action tablet combining PARP inhibition and hormone therapy for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC)."
    FDA event
    |
    FoundationOne® Liquid CDx
    |
    Akeega (abiraterone/niraparib)
    7ms
    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)
    8ms
    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)
    8ms
    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)
    over1year
    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)
    over1year
    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)
    over1year
    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)
    almost2years
    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)