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DRUG:

abiraterone acetate

i
Other names: CB 7630, JNJ-212082, CB-7630, CB7630, BR9004
Company:
Generic mfg.
Drug class:
CYP17A1 inhibitor
2d
Randomized Phase II Study of ADT + Abiraterone vs ADT + Docetaxel + Abiraterone (clinicaltrials.gov)
P2, N=150, Active, not recruiting, Northwestern University | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2028 --> May 2024
Enrollment closed • Trial primary completion date • Metastases
|
docetaxel • abiraterone acetate • dexamethasone injection
4d
Prognostic and Predictive Role of SPOP Mutations in Prostate Cancer: A Systematic Review and Meta-analysis. (PubMed, Eur Urol Oncol)
Patients with SPOPmut PC seem to exhibit superior oncological outcomes compared with patients with SPOPwt. Tailored risk stratification and treatment approaches should be explored in such patients.
Retrospective data • Review • Journal
|
SPOP (Speckle Type BTB/POZ Protein)
|
SPOP mutation
|
docetaxel • abiraterone acetate
9d
New P2 trial • Metastases
|
docetaxel • Zejula (niraparib) • abiraterone acetate • Akeega (abiraterone/niraparib)
9d
A Modular Trial of Androgen Signaling Inhibitor Combinations Testing a Risk-Adapted Strategy in Patients with Metastatic Castration-Resistant Prostate Cancer. (PubMed, Clin Cancer Res)
Adding ipilimumab to AAPA did not improve outcomes in men with androgen responsive mCRPC. Despite the addition of carboplatin+cabazitaxel, men in the Unsatisfactory group had shortened survivals. Adaptive designs can enrich for biologically and clinically relevant disease subgroups, to contribute to the development of marker-informed, risk-adapted therapy strategies in men with prostate cancer.
Journal • Metastases
|
PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1) • SPP1 (Secreted Phosphoprotein 1) • IGFBP2 (Insulin-like growth factor binding protein 2)
|
Yervoy (ipilimumab) • carboplatin • abiraterone acetate • prednisone • cabazitaxel • Erleada (apalutamide)
10d
CELLO-1: A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer (clinicaltrials.gov)
P1/2, N=102, Active, not recruiting, Epizyme, Inc. | Trial completion date: Mar 2024 --> Jun 2024 | Trial primary completion date: Mar 2024 --> Jun 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
EZH2 (Enhancer of zeste 2 polycomb repressive complex 2 subunit)
|
Xtandi (enzalutamide capsule) • abiraterone acetate • Tazverik (tazemetostat)
13d
DynaMO: Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P2, N=196, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: May 2025 --> Mar 2026 | Trial primary completion date: May 2025 --> Mar 2026
Trial completion date • Trial primary completion date • Metastases
|
AR (Androgen receptor)
|
Yervoy (ipilimumab) • carboplatin • abiraterone acetate • prednisone • cabazitaxel • Erleada (apalutamide)
14d
CAPItello-281: Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency (clinicaltrials.gov)
P3, N=1012, Active, not recruiting, AstraZeneca | Trial primary completion date: Apr 2025 --> Oct 2024
Trial primary completion date • Metastases
|
PTEN (Phosphatase and tensin homolog)
|
abiraterone acetate • Truqap (capivasertib)
15d
Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland (clinicaltrials.gov)
P=N/A, N=1, Completed, Pfizer | Trial completion date: Jun 2023 --> Apr 2024 | Trial primary completion date: Jun 2023 --> Apr 2024
Trial completion date • Trial primary completion date • HEOR • Real-world evidence • Real-world • Metastases
|
docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • cabazitaxel • Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Xofigo (radium Ra-223 dichloride) • leuprolide acetate for depot suspension
15d
Enrollment open
|
abiraterone acetate • Yonsa (abiraterone acetate)
15d
New trial • Real-world evidence • Real-world • Metastases
|
Lynparza (olaparib) • abiraterone acetate
16d
KNIGHTS: High-Risk Metachronous Oligometastatic Prostate Cancer Trial (clinicaltrials.gov)
P2, N=88, Recruiting, University of Maryland, Baltimore | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • CHEK2 (Checkpoint kinase 2) • RAD51B (RAD51 Paralog B) • RAD54L (DNA Repair And Recombination Protein RAD54)
|
BRCA2 mutation • BRCA1 mutation • ATM mutation • PALB2 mutation • FANCA mutation
|
Zejula (niraparib) • abiraterone acetate
16d
New P2 trial • Metastases
|
Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
21d
Trial primary completion date • Combination therapy • Metastases
|
Verzenio (abemaciclib) • abiraterone acetate • prednisone
22d
Predicting abiraterone efficacy in advanced prostate cancer: Insights from marker of proliferation Ki67. (PubMed, Prostate)
This study highlights KI67 positivity in prostate biopsy as a strong predictor of abiraterone efficacy in advanced PCa. These insights will assist clinicians in anticipating clinical outcomes and refining treatment decisions for PCa patients.
Journal • Metastases
|
MKI67 (Marker of proliferation Ki-67)
|
abiraterone acetate
22d
ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P2, N=200, Recruiting, Zenith Epigenetics | Phase classification: P2b --> P2 | Trial completion date: Sep 2024 --> Jun 2025 | Trial primary completion date: Mar 2024 --> Dec 2024
Phase classification • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Xtandi (enzalutamide capsule) • abiraterone acetate • ZEN-3694
22d
New P2 trial
|
abiraterone acetate • Yonsa (abiraterone acetate)
23d
PET/CT Characterization of Treatment Resistance (clinicaltrials.gov)
P=N/A, N=20, Recruiting, University of Wisconsin, Madison | Trial completion date: Sep 2024 --> Mar 2027 | Trial primary completion date: Sep 2024 --> Mar 2025
Trial completion date • Trial primary completion date
|
abiraterone acetate
24d
Micro RNAs to Predict Response to Androgen Deprivation Therapy (clinicaltrials.gov)
P=N/A, N=42, Active, not recruiting, Medical College of Wisconsin | N=60 --> 42
Enrollment change
|
docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • bicalutamide • Erleada (apalutamide) • triptorelin • goserelin acetate • leuprolide acetate for depot suspension
25d
First-line combination treatment with PARP and androgen receptor-signaling inhibitors in HRR-deficient mCRPC: Applying clinical study findings to clinical practice in the United States. (PubMed, Cancer Treat Rev)
Here, we review the newly approved PARPi plus ARSI treatments within the context of the mCRPC treatment landscape, provide an overview of practical considerations for the combinations in clinical practice, highlight the importance of HRR testing, and discuss the benefits of treatment intensification for patients with mCRPC.
Review • Journal
|
HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
|
Lynparza (olaparib) • Talzenna (talazoparib) • Zejula (niraparib) • Xtandi (enzalutamide capsule) • abiraterone acetate • prednisone
27d
Stereotactic Ablative Radiation Therapy for Abiraterone-Resistant, Oligoprogressive Metastatic Prostate Cancer (clinicaltrials.gov)
P=N/A, N=30, Recruiting, Sunnybrook Health Sciences Centre | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2025
Trial completion date • Trial primary completion date • Metastases
|
abiraterone acetate
29d
Study of PCUR-101 in Combination With ADT in Patients With mCRPC (clinicaltrials.gov)
P1, N=7, Terminated, Pellficure Pharmaceuticals, Inc | N=48 --> 7 | Recruiting --> Terminated; Business Decision due to insufficient enrollment
Enrollment change • Trial termination • Combination therapy • Metastases
|
abiraterone acetate • prednisone
30d
Current Systemic Therapy in Men with Metastatic Castration-Sensitive Prostate Cancer. (PubMed, Curr Oncol Rep)
In less than a decade, evidence was chronologically provided that (1) systemic treatment intensification with docetaxel improves outcomes, including survival, in men with mCSPC, (2) then that these outcomes are also improved when a second-generation androgen receptor pathway inhibitor (ARPI) is combined with androgen deprivation therapy (ADT), and (3) using a "triplet systemic therapy," which consists in the combination of ADT, an ARPI and docetaxel, further improves outcomes, including survival...Combining prostate radiotherapy and intensified systemic treatment including abiraterone may be synergistic as suggested in the PEACE-1 trial...Importantly, most evidence currently available was obtained in men with de novo metastases, while for those with metastatic relapse after definitive local treatment, the role of treatment intensification is less well established. Treatment intensification is nowadays the standard of care for patients with de novo mCSPC as it leads to outcomes improvement, including survival, and the standard of care is evolving almost on a yearly basis.
Review • Journal • BRCA Biomarker • Metastases
|
BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • FOLH1 (Folate hydrolase 1)
|
FOLH1 expression
|
docetaxel • abiraterone acetate
30d
Tamarack: A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors (clinicaltrials.gov)
P2, N=382, Active, not recruiting, MacroGenics | N=100 --> 382 | Trial completion date: Dec 2026 --> May 2027 | Trial primary completion date: Dec 2026 --> May 2027
Enrollment change • Trial completion date • Trial primary completion date • Metastases
|
abiraterone acetate • vobramitamab duocarmazine (MGC018)
1m
Trial completion • Metastases
|
Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide)
1m
Trial of ARV-110 and Abiraterone in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
P1, N=40, Active, not recruiting, Arvinas Androgen Receptor, Inc. | Trial primary completion date: Apr 2024 --> Jul 2024
Trial primary completion date • Combination therapy • Metastases
|
abiraterone acetate • bavdegalutamide (ARV-110)
1m
P3 data • Journal • PARP Biomarker • Metastases
|
HRD (Homologous Recombination Deficiency)
|
Lynparza (olaparib) • abiraterone acetate
1m
Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients (clinicaltrials.gov)
P3, N=200, Recruiting, The First Affiliated Hospital with Nanjing Medical University
New P3 trial • Metastases
|
docetaxel • abiraterone acetate
1m
Real-World Overall Survival and Treatment Patterns by PTEN Status in Metastatic Castration-Resistant Prostate Cancer. (PubMed, JCO Precis Oncol)
PTEN LOF, identified with genomic testing, was associated with decreased survival and negative prognoses in patients with mCRPC.
Journal • Real-world evidence • Real-world • Metastases
|
PTEN (Phosphatase and tensin homolog)
|
Xtandi (enzalutamide capsule) • abiraterone acetate
1m
Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of ARN 509 in Combination With Abiraterone Acetate (clinicaltrials.gov)
P1, N=6, Completed, Aragon Pharmaceuticals, Inc. | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Feb 2024
Trial completion • Trial completion date • Combination therapy • Metastases
|
abiraterone acetate • prednisone • Erleada (apalutamide)
1m
A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan (clinicaltrials.gov)
P=N/A, N=979, Active, not recruiting, Janssen Pharmaceutical K.K. | Trial completion date: Aug 2024 --> Oct 2025 | Trial primary completion date: Aug 2024 --> Oct 2025
Trial completion date • Trial primary completion date • Metastases
|
docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • bicalutamide • Erleada (apalutamide) • goserelin acetate
1m
New P1/2 trial • Metastases
|
Zejula (niraparib) • abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Akeega (abiraterone/niraparib)
1m
CABPOSTAAT: Docetaxel Versus Cabazitaxel Post Abiraterone or Enzalutamide (clinicaltrials.gov)
P2, N=214, Active, not recruiting, Centre hospitalier de l'Université de Montréal (CHUM) | Recruiting --> Active, not recruiting
Enrollment closed
|
docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • prednisone • cabazitaxel
2ms
Enrollment closed • Metastases
|
CD4 (CD4 Molecule)
|
Oncotype DX Genomic Prostate Score® Assay
|
abiraterone acetate • prednisone • Erleada (apalutamide)
2ms
CHOMP: A Study of CHeckpoint Inhibitors in Men With prOgressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation (clinicaltrials.gov)
P2, N=30, Recruiting, VA Office of Research and Development | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
Trial completion date • Trial primary completion date • Checkpoint inhibition • Mismatch repair • Metastases
|
EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • CDK12 (Cyclin dependent kinase 12) • PMS1 (PMS1 protein homolog 1)
|
MSI-H/dMMR
|
Keytruda (pembrolizumab) • abiraterone acetate
2ms
Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov)
P2, N=30, Recruiting, Peking Union Medical College | Initiation date: Dec 2023 --> May 2024
Trial initiation date • Metastases
|
cisplatin • erlotinib • carboplatin • sorafenib • AiTan (rivoceranib) • albumin-bound paclitaxel • abiraterone acetate • bicalutamide • larotinib (Z650) • ESG401 • Entyvio (vedolizumab)
2ms
Trial completion date • Metastases
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ATM (ATM serine/threonine kinase) • BRCA (Breast cancer early onset)
|
BRCA2 mutation • BRCA1 mutation • ATM mutation • BRCA1 mutation + ATM mutation
|
docetaxel • Xtandi (enzalutamide capsule) • Rubraca (rucaparib) • abiraterone acetate
2ms
New P3 trial • Metastases
|
docetaxel • Zejula (niraparib) • Xtandi (enzalutamide capsule) • abiraterone acetate • Erleada (apalutamide) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Akeega (abiraterone/niraparib)
2ms
A Neoadjuvant Study of Abiraterone Acetate, Leuprolide Acetate, and Belzutifan in Men With Regional Prostate Cancer (clinicaltrials.gov)
P2, N=0, Withdrawn, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | N=30 --> 0 | Not yet recruiting --> Withdrawn
Enrollment change • Trial withdrawal
|
abiraterone acetate • Welireg (belzutifan) • leuprolide acetate for depot suspension
2ms
Ductal, intraductal, and cribriform carcinoma of the prostate: Molecular characteristics and clinical management. (PubMed, Urol Oncol)
Evidence suggests abiraterone may be superior to docetaxel as a first-line treatment for patients with IDC-P. To address these and other critical pathological attributes, this review examines the molecular pathology, genetics, treatments, and oncologic outcomes associated with CC-P, PDA, and IDC-P with the objective of creating a comprehensive resource with a centralized repository of information on PDA, IDC-P, and CC-P.
Review • Journal • BRCA Biomarker
|
TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • HRD (Homologous Recombination Deficiency) • RB1 (RB Transcriptional Corepressor 1) • PALB2 (Partner and localizer of BRCA2) • CHEK2 (Checkpoint kinase 2) • CHD1 (Chromodomain Helicase DNA Binding Protein 1) • MAP3K7 (Mitogen-Activated Protein Kinase Kinase Kinase 7) • NKX3-1 (NK3 homeobox 1)
|
TP53 mutation • PTEN mutation • PALB2 mutation • CHEK2 mutation
|
docetaxel • abiraterone acetate
2ms
DHODH inhibition represents a therapeutic strategy and improves abiraterone treatment in castration-resistant prostate cancer. (PubMed, Oncogene)
However, the combination treatment with BAY2402234 and abiraterone decreased intratumoral testosterone levels and induced apoptosis, which inhibited the growth of CWR22Rv1 xenograft tumors and patient-derived xenograft organoids. Taken together, these results establish DHODH as a key player in CRPC and as a potential therapeutic target for advanced prostate cancer.
Journal
|
DHODH (Dihydroorotate Dehydrogenase (Quinone))
|
abiraterone acetate • orludodstat (BAY2402234)
2ms
Loss of AR-regulated AFF3 contributes to prostate cancer progression and reduces ferroptosis sensitivity by downregulating ACSL4 based on single-cell sequencing analysis. (PubMed, Apoptosis)
Based on the research of the AR pathway, new drugs for the treatment of CRPC have been developed in clinical practice, such as Abiraterone and enzalutamide. Based on correlation analysis and flow cytometry, we can speculate that AFF3 can impact the sensitivity of the CRPC cell lines to the ferroptosis inducer (RSL3) by regulating ACSL4. Therefore, our findings may provide new insights into the mechanisms of drug resistance in CRPC, and AFF3 may serve as a novel prognostic biomarker in prostate cancer.
Journal
|
AR (Androgen receptor) • ACSL4 (Acyl-CoA Synthetase Long Chain Family Member 4) • AFF3 (AF4/FMR2 Family Member 3)
|
AR mutation • AR expression
|
Xtandi (enzalutamide capsule) • abiraterone acetate • RSL3
2ms
FOcal Radiation for Oligometastatic Castration-rEsistant Prostate Cancer (FORCE) (clinicaltrials.gov)
P2, N=13, Completed, University of Michigan Rogel Cancer Center | Active, not recruiting --> Completed | Trial completion date: Mar 2024 --> Jul 2023
Trial completion • Trial completion date • Metastases
|
docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • cabazitaxel