P1, N=174, Recruiting, Astellas Pharma Global Development, Inc. | Trial completion date: Apr 2025 --> May 2029 | Trial primary completion date: Dec 2024 --> Aug 2025

P2, N=58, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2030 --> Mar 2032 | Initiation date: Dec 2024 --> Mar 2025 | Trial primary completion date: Dec 2030 --> Mar 2031

P1, N=19, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2024 --> Jul 2025

Abiraterone combined with prednisone effectively relieves bone pain and improves PSA response rates in CRPC patients, suggesting benefits in enhancing quality of life and reducing testosterone levels without increasing adverse reactions. This therapy appears to have a safety profile comparable to that of conventional treatments.

In vivo experiments also revealed that combination therapy significantly inhibited tumour growth and reduced inducible expression of PPP1CA. PPP1CA is a key driver for abiraterone resistance, and nodularin-R enhances the anti-CRPC effects of abiraterone by inhibiting PPP1CA.

P2, N=60, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Sep 2024 --> Dec 2024

P2, N=0, Withdrawn, M.D. Anderson Cancer Center | Active, not recruiting --> Withdrawn

P3, N=72, Not yet recruiting, Emory University

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.

P1, N=26, Terminated, DisperSol Technologies, LLC | N=54 --> 26 | Active, not recruiting --> Terminated; Dose escalation portion of the study completed, one expansion cohort was eliminated due to change in standard of care, and the second cohort was not enrolled based on future development considerations.

These findings demonstrate that Abi + Chl treatment lowers autophagy levels and suppresses tumors more effectively than Abi alone.

No abstract available

P2, N=58, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

In this study, we calculated the binding free energy landscape of known ligands at this site using Funnel Metadynamics. Our results characterize this binding site and indicate that nonheme-interacting ligands could effectively bind to CYP17A1, providing a novel approach to the design of CYP17A1 inhibitors.

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.

P1/2, N=102, Active, not recruiting, University of Michigan Rogel Cancer Center | Recruiting --> Active, not recruiting

Abi-DTPA was the main form in the plasma and exhibited lower toxicity after intravenous administration. These findings suggest that Abi-DTPA can be used as a novel injectable anti-prostate cancer agent.

P1, N=174, Recruiting, Astellas Pharma Global Development, Inc. | Phase classification: P1/2 --> P1 | N=100 --> 174

P3, N=246, Recruiting, Universitaire Ziekenhuizen KU Leuven

P2, N=60, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Jun 2024 --> Sep 2024

P1/2, N=49, Completed, Laekna Limited | Active, not recruiting --> Completed | N=74 --> 49 | Trial completion date: Oct 2024 --> Mar 2024

Our results unveiled a new role of L1CAM in the acquisition of the NE phenotype in PC, contributing to the NE differentiation-related therapeutic resistance of CRPC.

As other known AKR1C3 inhibitors, compound 4 determined a significantly increased activity of abiraterone, a drug approved for advanced prostate cancer. Compound 4 also showed a synergic effect with doxorubicin in osteosarcoma cell lines; specifically, the effect is correlated with AKR1C3 expression. In this research work, therefore, the use of AI allowed the identification of a new structure as an AKR1C3 inhibitor and its potential to enhance the effect of chemotherapeutics.

The combination of Prog and Abi represents a promising therapeutic approach for GBM, showing potential in suppressing tumor growth, extending survival, and modulating the immune microenvironment. These findings warrant further exploration into the clinical applicability of this strategy to improve outcomes for GBM patients.

P2, N=43, Not yet recruiting, Qilu Hospital of Shandong University

"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)."

We also challenged this system with abiraterone, a steroidogenic inhibitor, to validate its suitability as an in vitro platform for endocrine toxicology tests...Finally, we showed that the production of testosterone and estradiol in this system can be inhibited in response to the steroidogenic inhibitor. Taken together, our organoid system provides a promising in vitro platform for male reproductive toxicology studies on testis morphogenesis, somatic cell maturation, and endocrine production.

P2, N=100, Recruiting, University of Washington | Trial completion date: Jul 2029 --> Jul 2031 | Trial primary completion date: Jul 2024 --> Jul 2026

Additionally, through in silico analysis, we identified target genes and transcription factors of the two miRNAs, including PTEN and HOXB13, which are known to play roles in AA resistance in mCRPC. In summary, our study highlights two c-miRNAs as potential companion diagnostics of AA in mCRPC patients, offering novel insights for informed decision-making in the treatment of mCRPC.

The first is the hydroxylation of pregnenolone or progesterone to the corresponding 17α-hydroxy steroid, followed by a lyase reaction that converts these 17α-hydroxy intermediates to the androgens dehydroepiandrosterone and androstenedione, respectively...Extensive sequential backbone 1H,15N and 13C nuclear magnetic resonance assignments have now been made for oxidized CYP17A1 bound to the prostate cancer drug and inhibitor abiraterone...These assignments allow more complete interpretation of the structural perturbations observed upon cytb5 addition. Possible mechanism(s) for the effector activity of cytb5 are discussed in light of this new information.

P2, N=131, Active, not recruiting, Janssen Biotech, Inc. | Trial completion date: Jul 2024 --> Jul 2025

Our data indicated that the combination of metformin with AA and the combination of metformin, silodosin and AA decreased the hTERT levels when compared to control, AA, and silodosin with AA. The administration of metformin resulted in a reduction of hTERT levels in the PC3 cell line, but the impact of silodosin on hTERT levels was not statistically significant compared to AA group.

P=N/A, N=40, Active, not recruiting, Massachusetts General Hospital | Trial completion date: Dec 2021 --> Dec 2024 | Trial primary completion date: Dec 2021 --> Jun 2024

Adding AAP to salvage radiation therapy and goserelin resulted in high bRFS and alt-bRFS. AEs remained manageable, although a close liver surveillance is advised. CTC count appears as a promising biomarker for prognosis and predicting response to treatment.

P2, N=150, Active, not recruiting, Northwestern University | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2028 --> May 2024

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.

P1/2, N=13, Terminated, Institute of Cancer Research, United Kingdom | Trial completion date: Oct 2024 --> Nov 2023 | Active, not recruiting --> Terminated; Funder decided that response outcomes to date did not support continuation of the study.

P2, N=64, Recruiting, Mayo Clinic | Not yet recruiting --> Recruiting

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.

P2, N=64, Not yet recruiting, Mayo Clinic

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