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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
3d
Randomized Phase II Study of Durvalumab with or without Tremelimumab in Patients with Metastatic Castration Resistant Prostate Cancer. (PubMed, Clin Cancer Res)
D+T is active in mCRPC but patient selection remains a challenge. Further studies to develop predictive biomarkers are warranted.
P2 data • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8)
|
TMB-H • PD-L1 overexpression
|
Imfinzi (durvalumab) • Xtandi (enzalutamide capsule) • Imjudo (tremelimumab) • abiraterone acetate
4d
New P1/2 trial
|
abiraterone acetate • prednisone • M9466
4d
Study of Abiraterone Acetate Without Exogenous Glucocorticoids in Men With Castration-resistant Prostate Cancer (clinicaltrials.gov)
P2, N=60, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Sep 2024 --> Dec 2024
Trial completion date
|
abiraterone acetate
5d
Cabozantinib and Abiraterone With Checkpoint Inhibitor Immunotherapy in Metastatic Hormone Sensitive Prostate Cancer (CABIOS Trial) (clinicaltrials.gov)
P1, N=18, Active, not recruiting, Washington University School of Medicine | Trial completion date: Mar 2026 --> Sep 2025
Trial completion date
|
Opdivo (nivolumab) • Cabometyx (cabozantinib tablet) • abiraterone acetate • prednisone
6d
EPI-7386-CS-001: Oral EPI-7386 in Patients with Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P1, N=99, Active, not recruiting, ESSA Pharmaceuticals | Recruiting --> Active, not recruiting | Trial completion date: Sep 2026 --> Jan 2025 | Trial primary completion date: Apr 2026 --> Oct 2024
Enrollment closed • Trial completion date • Trial primary completion date
|
abiraterone acetate • Erleada (apalutamide) • masofaniten (EPI-7386)
10d
Study of Relugolix in Men with Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P1, N=48, Completed, Sumitomo Pharma Switzerland GmbH | Active, not recruiting --> Completed | N=72 --> 48 | Trial completion date: May 2025 --> May 2024 | Trial primary completion date: May 2025 --> May 2024
Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
docetaxel • abiraterone acetate • prednisone • Erleada (apalutamide) • Orgovyx (relugolix) • Yonsa (abiraterone acetate)
12d
ProstACT-GLOBAL: The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT GLOBAL) (clinicaltrials.gov)
P3, N=430, Recruiting, Telix Pharmaceuticals (Innovations) Pty Limited | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy • Metastases
|
docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • 177Lu-rosopatamab tetraxetan (TLX591)
15d
Efficacy and Predictive Factors Analysis of Androgen Deprivation Plus Novel Hormone Therapy as Neoadjuvant Treatment for High-Risk Prostate Cancer. (PubMed, Prostate)
Herein, we demonstrated the superior performance of ADT plus apalutamide in achieving pCR or MRD and in extending BCR duration among HRPC patients. Post-intervention pre-RP PSA content as well as genetic shifts, especially in the AR axis, are critical indicators of patient pathological and clinical outcomes. These findings highlight the significance of genetic testing and PSA content monitoring in treating HRPC patients.
Journal
|
TP53 (Tumor protein P53)
|
TP53 mutation
|
abiraterone acetate • Erleada (apalutamide)
15d
Tumor regression after neoadjuvant hormonal therapy in high risk prostate cancer: pathological outcomes from a randomized phase II trial. (PubMed, World J Urol)
There are subgroups of patients, such as those with low baseline cancer burden and PTEN/ERG wild-type status, more likely to achieve good response with nADT. In the case of long term oncological benefit to be proven, nADT might be an additional therapeutic resource for these patients.
Clinical • P2 data • Journal
|
PTEN (Phosphatase and tensin homolog)
|
abiraterone acetate • prednisone • Erleada (apalutamide) • goserelin acetate
17d
Trial primary completion date
|
AR (Androgen receptor)
|
AR splice variant 7 • AR-V7 positive • AR-V7 negative • AR splice variant 7 negative
|
docetaxel • abiraterone acetate • prednisone • cabazitaxel
18d
CURLu177PSM0001: 177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P3, N=439, Active, not recruiting, Curium US LLC | Trial completion date: Jun 2029 --> Feb 2029
Trial completion date • Metastases
|
Xtandi (enzalutamide capsule) • abiraterone acetate • prednisone
22d
Side effect management algorithms for niraparib/abiraterone acetate in prostate cancer. (PubMed, Can J Urol)
These algorithms are intended to provide practical assistance to Canadian clinicians managing the most common AEs encountered with the novel combination, niraparib/AA+P, for mCRPC.
Journal • Adverse events • BRCA Biomarker • PARP Biomarker
|
BRCA (Breast cancer early onset)
|
BRCA mutation
|
Zejula (niraparib) • abiraterone acetate • prednisone
26d
New P2 trial • Metastases
|
Xtandi (enzalutamide capsule) • abiraterone acetate
27d
PSA-DEEP02: PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer (clinicaltrials.gov)
P=N/A, N=152, Not yet recruiting, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
New trial • Metastases
|
docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • prednisone • Nubeqa (darolutamide) • Erleada (apalutamide)
27d
Trial withdrawal
|
abiraterone acetate
28d
New P3 trial • Metastases
|
abiraterone acetate • bicalutamide • Orgovyx (relugolix) • leuprolide acetate for depot suspension • Yonsa (abiraterone acetate)
28d
Trial completion date • Combination therapy • Metastases
|
abiraterone acetate • prednisone • Erleada (apalutamide)
29d
Androgen receptor pathway inhibitors and drug-drug interactions in prostate cancer. (PubMed, ESMO Open)
These interactions, particularly through pathways like CYP2D6 inhibition by abiraterone and CYP3A4 induction by enzalutamide and apalutamide, necessitate a thorough understanding to optimize therapeutic outcomes and minimize adverse effects. This review aims to delineate the efficacy of ARPIs in prostate cancer management and elucidate their interaction with common medications, highlighting the importance of vigilant drug management to optimize patient care.
Review • Journal
|
CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
|
Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide)
1m
Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 (Apalutamide) in Castration-Resistant Prostate Cancer (CRPC) (clinicaltrials.gov)
P1/2, N=127, Active, not recruiting, Aragon Pharmaceuticals, Inc. | Trial completion date: Dec 2024 --> Dec 2027
Trial completion date • Metastases
|
abiraterone acetate • Erleada (apalutamide)
1m
Circ_0001047 inhibits prostate cancer progression and enhances abiraterone sensitivity via miR-122-5p/FKBP5/PHLPP1/AKT axis in vitro. (PubMed, Discov Oncol)
This study revealed a novel mechanism by which circ_0001047 regulates PCa progression and treatment sensitivity via the miR-122-5p/FKBP5/PHLPP1/AKT axis. These findings deepen our comprehension of the molecular mechanisms in latent PCa progression and treatment resistance.
Preclinical • Journal
|
PHLPP1 (PH Domain And Leucine Rich Repeat Protein Phosphatase 1) • FKBP5 (FKBP Prolyl Isomerase 5) • MIR122 (MicroRNA 122)
|
FKBP5 expression
|
abiraterone acetate
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) | Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Jul 2024 --> Dec 2024
Trial completion date • Trial primary completion date
|
docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • prednisone • cabazitaxel
1m
Physical Function During ARSI Treatment (clinicaltrials.gov)
P=N/A, N=24, Recruiting, UNC Lineberger Comprehensive Cancer Center | Active, not recruiting --> Recruiting
Enrollment open • Metastases
|
Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide)
1m
Trial primary completion date • Metastases
|
Xtandi (enzalutamide capsule) • abiraterone acetate • vobramitamab duocarmazine (MGC018)
1m
Simultaneous Autophagy and Androgen Receptor Inhibition in a Prostate Cancer Xenograft Model. (PubMed, Cancers (Basel))
These findings demonstrate that Abi + Chl treatment lowers autophagy levels and suppresses tumors more effectively than Abi alone.
Preclinical • Journal
|
FOLH1 (Folate hydrolase 1) • ATG5 (Autophagy Related 5) • BECN1 (Beclin 1)
|
AR expression • FOLH1 expression • ATG5 expression
|
abiraterone acetate • prednisone
1m
PROCeed-BR: Real-life Experience in Brazil in Patients With Castration-resistant Prostate Cancer Treated With Olaparib+Abiraterone (clinicaltrials.gov)
P=N/A, N=80, Not yet recruiting, AstraZeneca | Trial completion date: Sep 2025 --> Dec 2025 | Trial primary completion date: Sep 2025 --> Dec 2025
Trial completion date • Trial primary completion date • Real-world evidence • Real-world
|
Lynparza (olaparib) • abiraterone acetate
1m
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials (clinicaltrials.gov)
P=N/A, N=120, Recruiting, Duke University | Trial completion date: Oct 2026 --> Apr 2027 | Trial primary completion date: Oct 2026 --> Apr 2027
Trial completion date • Trial primary completion date • Tumor cell • Metastases
|
abiraterone acetate
1m
Targeted Delivery of AR-V7 siRNA with Bivalent PSMA Aptamers Effectively Suppresses the Growth of Enzalutamide-Resistant Prostate Cancer. (PubMed, Mol Pharm)
For FDA-approved second-generation androgen receptor (AR) antagonists, including enzalutamide (ENZ) and abiraterone (AA), patients who initially respond to them eventually develop resistance. ENZ combined with PAP can significantly inhibit 22Rv1 xenograft growth in mice without experiencing castration. Owing to the low toxicity, PAP has potential to offer a new antiandrogen treatment for current ENZ-resistant PCa.
Journal
|
AR (Androgen receptor)
|
AR splice variant 7 • AR-V7 expression • FOLH1 expression
|
Xtandi (enzalutamide capsule) • abiraterone acetate
1m
Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial (clinicaltrials.gov)
P2, N=474, Not yet recruiting, Alliance for Clinical Trials in Oncology
New P2 trial
|
carboplatin • Xtandi (enzalutamide capsule) • abiraterone acetate • cabazitaxel • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Ezharmia (valemetostat)
1m
Enrollment change
|
docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • prednisone • Nubeqa (darolutamide) • cabazitaxel • Erleada (apalutamide) • cetrelimab (JNJ-63723283) • JNJ-8343
1m
A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P1, N=57, Active, not recruiting, Aragon Pharmaceuticals, Inc. | Trial completion date: Dec 2024 --> Dec 2027
Trial completion date • Metastases
|
abiraterone acetate • prednisone • Erleada (apalutamide)
1m
New P3 trial • Metastases
|
Xtandi (enzalutamide capsule) • abiraterone acetate • mevrometostat (PF-06821497)
1m
Combining Ipilimumab With Abiraterone Acetate Plus Prednisone in Chemotherapy and Immunotherapy-naïve Patients With Progressive Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov)
P1/2, N=57, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
Trial completion date • Trial primary completion date • Metastases
|
Yervoy (ipilimumab) • abiraterone acetate • prednisone
2ms
Journal
|
AR (Androgen receptor)
|
abiraterone acetate • niclosamide
2ms
Study Evaluating Zenocutuzumab in Patients with or Without Molecularly Defined Cancers (clinicaltrials.gov)
P2, N=90, Active, not recruiting, Merus N.V. | Recruiting --> Active, not recruiting
Enrollment closed
|
NRG1 (Neuregulin 1)
|
NRG1 fusion
|
Gilotrif (afatinib) • Xtandi (enzalutamide capsule) • abiraterone acetate • zenocutuzumab (MCLA-128)
2ms
Enrollment open
|
docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • mevrometostat (PF-06821497)
2ms
Connecting Gene Variation to Treatment Outcomes in Metastatic Castration-Resistant Prostate Adenocarcinoma: Insights into Second-Generation Androgen Receptor Axis-Targeted Therapies. (PubMed, Int J Mol Sci)
Second-generation androgen receptor axis-targeted (ARAT) agents, namely abiraterone acetate (AbA) and enzalutamide (ENZ), are currently used in the management of metastatic castration-resistant PC (mCRPC). In the same subgroup, significant associations of HSD3B1 rs1047303 (CC/CA vs. AA; HR = 3.41; p = 0.025), YBX1 rs12030724 (AT vs. AA; HR = 3.54; p = 0.039) and YBX1 rs10493112 (log-rank test, p = 0.041; CC vs. AA/AC; HR = 3.22; p = 0.053) with overall survival were also observed, which were confirmed by multivariate Cox analyses. Although validation with larger cohorts is required, these findings suggest that SNPs could enhance the prognosis assessment of mCRPC patients, leading to a more personalised treatment.
Journal • Metastases
|
CYP17A1 (Cytochrome P450 Family 17 Subfamily A Member 1) • YBX1 (Y-Box Binding Protein 1) • HSD3B1 (Hydroxy-Delta-5-Steroid Dehydrogenase 3 Beta- And Steroid Delta-Isomerase 1)
|
YBX1 rs10493112
|
Xtandi (enzalutamide capsule) • abiraterone acetate
2ms
New P2 trial
|
abiraterone acetate • dexamethasone
2ms
Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer (clinicaltrials.gov)
P2, N=60, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Oct 2024 --> Oct 2026 | Trial primary completion date: Oct 2024 --> Oct 2026
Trial completion date • Trial primary completion date • Metastases
|
abiraterone acetate • Erleada (apalutamide) • Yonsa (abiraterone acetate)
2ms
Body composition in recurrent prostate cancer and the role of steroidogenic genotype. (PubMed, Endocr Relat Cancer)
Men with biochemically recurrent prostate cancer (BCR) who received 8 months of LHRH analog (LHRHa) +/- abiraterone acetate (AAP) were eligible if they had: 1) CT imaging of L3 prior to and after treatment, and 2) nucleated cells collected...An inherited polymorphism in SRD5A2 and T2DM were associated with differential skeletal muscle toxicity. These findings suggest that inherited polymorphisms may contribute to the body composition toxicity observed with HT.
Journal
|
HSD3B1 (Hydroxy-Delta-5-Steroid Dehydrogenase 3 Beta- And Steroid Delta-Isomerase 1) • SRD5A2 (Steroid 5 Alpha-Reductase 2)
|
abiraterone acetate
2ms
Enrollment closed
|
DRD (DNA Repair Deficiency)
|
DDR • DRD
|
Zejula (niraparib) • abiraterone acetate • leuprolide acetate for depot suspension
2ms
ORIC-944-01: Study of ORIC-944 in Patients with Metastatic Prostate Cancer (clinicaltrials.gov)
P1, N=250, Recruiting, ORIC Pharmaceuticals | N=42 --> 250 | Trial completion date: Jun 2024 --> Sep 2026 | Trial primary completion date: May 2023 --> Dec 2024
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide) • ORIC-944
2ms
Addition of Opaganib to Androgen Antagonists in Patients With mCRPC (clinicaltrials.gov)
P2, N=69, Completed, Medical University of South Carolina | Active, not recruiting --> Completed
Trial completion
|
Xtandi (enzalutamide capsule) • abiraterone acetate • Yeliva (opaganib)