NCT03751436

Enzalutamide With Venetoclax in Treating Patients With Metastatic Castration Resistant Prostate Cancer

Completed Phase 1 Last updated 16 October 2023

What this trial tests

Phase 1 trial testing Enzalutamide in Castration Levels of Testosterone in 10 participants. Completed in 11 August 2023.

Timeline

2 August 2019

Primary endpoint
18 July 2022

11 August 2023

Quick facts

Lead sponsor	Roswell Park Cancer Institute
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	2 August 2019
Primary completion	18 July 2022
Estimated completion	11 August 2023
Sites	1 location across United States

Drugs / interventions tested

• Enzalutamide (enzalutamide) — full drug profile →
• Venetoclax (venetoclax) — full drug profile →

Conditions studied

• Castration Levels of Testosterone — all drugs for Castration Levels of Testosterone →
• Castration-Resistant Prostate Carcinoma — all drugs for Castration-Resistant Prostate Carcinoma →
• Metastatic Prostate Carcinoma — all drugs for Metastatic Prostate Carcinoma →
• Metastatic Prostate Carcinoma in the Soft Tissue — all drugs for Metastatic Prostate Carcinoma in the Soft Tissue →

Sponsor

Roswell Park Cancer Institute

Who can join

18 and older, male only, with Castration Levels of Testosterone or Castration-Resistant Prostate Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase Ib/II trial studies the side effects and best dose of venetoclax when given together with enzalutamide and to see how well they work in treating patients with castration resistant prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, may lessen the amount of androgens made by the body. Venetoclax may target a special group of prostate cancer cells that is known to lead to resistance to treatment. Giving enzalutamide and venetoclax may work better in treating patients with castration resistant prostate cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Androgen receptor (AR) heterogeneity in prostate cancer and therapy resistance.
   Jamroze A, Chatta G, Tang DG. · · 2021 · cited 109× · PMID 34118355 · DOI 10.1016/j.canlet.2021.06.006
2. Understanding and targeting prostate cancer cell heterogeneity and plasticity.
   Tang DG. · · 2022 · cited 81× · PMID 34844845 · DOI 10.1016/j.semcancer.2021.11.001
3. Precision medicine by designer interference peptides: applications in oncology and molecular therapeutics.
   Sorolla A, Wang E, Golden E, Duffy C, et al · · 2020 · cited 74× · PMID 31636382 · DOI 10.1038/s41388-019-1056-3
4. BET Bromodomain Inhibition Blocks an AR-Repressed, E2F1-Activated Treatment-Emergent Neuroendocrine Prostate Cancer Lineage Plasticity Program.
   Kim DH, Sun D, Storck WK, Welker Leng K, et al · · 2021 · cited 65× · PMID 34145028 · DOI 10.1158/1078-0432.ccr-20-4968
5. Targeting the Intrinsic Apoptosis Pathway: A Window of Opportunity for Prostate Cancer.
   Westaby D, Jimenez-Vacas JM, Padilha A, Varkaris A, et al · · 2021 · cited 31× · PMID 35008216 · DOI 10.3390/cancers14010051
6. A Genome-Wide CRISPR Activation Screen Identifies PRRX2 as a Regulator of Enzalutamide Resistance in Prostate Cancer.
   Rodríguez Y, Unno K, Truica MI, Chalmers ZR, et al · · 2022 · cited 27× · PMID 35405009 · DOI 10.1158/0008-5472.can-21-3565
7. BCL2 expression is enriched in advanced prostate cancer with features of lineage plasticity.
   Westaby D, Jiménez-Vacas JM, Figueiredo I, Rekowski J, et al · · 2024 · cited 19× · PMID 39286979 · DOI 10.1172/jci179998
8. Preclinical Study Using ABT263 to Increase Enzalutamide Sensitivity to Suppress Prostate Cancer Progression Via Targeting BCL2/ROS/USP26 Axis Through Altering ARv7 Protein Degradation.
   Xu H, Sun Y, Huang CP, You B, et al · · 2020 · cited 14× · PMID 32235588 · DOI 10.3390/cancers12040831