What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly androgen receptor inhibitors like enzalutamide and abiraterone, and chemotherapy agents like docetaxel and cabazitaxel, have several known side effects. Enzalutamide can cause fatigue, peripheral edema, and diarrhea, while abiraterone is associated with hypertension, hypokalemia, and liver function abnormalities. Chemotherapy agents such as docetaxel and cabazitaxel often lead to neutropenia, neuropathy, and alopecia. These treatments can also cause gastrointestinal issues, fatigue, and increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, particularly for castration-resistant prostate cancer (CRPC). These include androgen receptor inhibitors such as enzalutamide, apalutamide, and darolutamide, which block androgen receptor signaling. Additionally, abiraterone acetate, which inhibits androgen production, has been approved. Radioligand therapy with lutetium Lu 177 vipivotide tetraxetan has also been approved for PSMA-positive metastatic CRPC. Immunotherapy options like pembrolizumab are available for patients with specific genetic markers. While BET inhibitors like ZEN003694 are still under investigation, these existing treatments provide a range of options for managing advanced prostate cancer.

What other types of research exist?

Promising novel alternatives to ZEN003694 for prostate cancer patients include: 1) Lutetium Lu 177 vipivotide tetraxetan, which has shown significant improvement in progression-free survival and overall survival in mCRPC patients. 2) Regorafenib, a multitargeted kinase inhibitor, which has demonstrated activity in progressive or metastatic osteosarcoma and may have potential in prostate cancer. 3) Enzalutamide, which is already used in combination with ZEN-3694 and has shown efficacy in mCRPC. These alternatives should be discussed with a healthcare provider to determine the best treatment plan.

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ZEN003694 Continuation for Prostate Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Zenith Epigenetics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial continues to provide ZEN003694 to patients who have already shown improvement from it in an earlier study. The medication helps by changing certain body functions related to their condition. Patients must have been part of an earlier study with this medication to join this continuation trial.

Who is the study for?

This trial is for prostate cancer patients who saw benefits from a previous ZEN003694 study. They should be in good physical condition (ECOG status of 0 or 1) and have handled the drug well before. Participants must start this follow-up within two weeks after their last dose in the original trial, unless given more time by the sponsor.

What is being tested?

The study continues treatment with ZEN003694 for those who benefited previously, alongside Enzalutamide, an established prostate cancer medication. The aim is to see if ongoing treatment maintains or improves patient outcomes.

What are the potential side effects?

While specific side effects are not listed here, participants must have tolerated ZEN003694 well during prior trials to join this continuation protocol. Side effects may include those experienced earlier plus any associated with Enzalutamide.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2019 Phase 1 & 2 trial • 75 Patients • NCT02711956

58%

Visual impairment

52%

Nausea

42%

Fatigue

32%

Decreased appetite

32%

Dysgeusia

19%

Thrombocytopenia

16%

Diarrhea

10%

Weight decreased

10%

Taste disorder

10%

Photosensitivity reaction

10%

Constipation

10%

Photopsia

10%

Vomiting

10%

Dizziness

10%

Blood creatinine increased

Intervertebral discitis

Acute kidney injury

Musculoskeletal pain

Myocardial ischaemia

Spinal cord compression

Rash maculopapular

100%

80%

60%

40%

20%

Study treatment Arm

DE/DC A+B 96 mg ZEN003694 + Enzalutamide

DE A+B 36 mg ZEN003694 + Enzalutamide

DE/DC A+B 48 mg ZEN003694 + Enzalutamide

DE A+B 60 mg ZEN003694 + Enzalutamide

DE A+B 72 mg ZEN003694 + Enzalutamide

DE A+B 120 mg ZEN003694 + Enzalutamide

DE A+B 144 mg ZEN003694 + Enzalutamide

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental: ZEN003694 in Combination with EnzalutamideExperimental Treatment2 Interventions

Patients who have completed participation in their original ZEN003694-002 protocol and have clinical benefit as determined by the investigator may continue to receive treatment with ZEN003694 in combination with enzalutamide

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~3820

ZEN003694

2016

Completed Phase 2

~120

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include androgen deprivation therapy (ADT), androgen receptor signaling inhibitors, and BET inhibitors like ZEN003694. ADT reduces androgen levels, which prostate cancer cells need to grow. Androgen receptor signaling inhibitors, such as enzalutamide and abiraterone, block the androgen receptor or inhibit androgen production, preventing cancer cell proliferation. BET inhibitors target proteins that regulate gene expression, including genes involved in cancer growth and survival. Understanding these mechanisms helps in selecting treatments tailored to the cancer's specific characteristics and resistance patterns.

Treatment pathways of Japanese prostate cancer patients - A retrospective transition analysis with administrative data.