What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly next-generation hormonal agents like abiraterone acetate and enzalutamide, have several known side effects. Abiraterone acetate can cause hypertension, hypokalemia, fluid retention, and liver function abnormalities. Enzalutamide may lead to fatigue, hot flashes, hypertension, and a risk of seizures. Both treatments can also result in cardiovascular issues, metabolic changes, sexual dysfunction, gynecomastia, and bone density loss.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that target androgen receptors or other pathways involved in cancer progression. Abiraterone acetate and enzalutamide are next-generation hormonal agents that inhibit androgen receptor signaling, crucial for prostate cancer cell growth. Additionally, lutetium Lu 177 vipivotide tetraxetan, a radioligand therapy, has been approved for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). Immunotherapies like pembrolizumab are also approved for specific genetic profiles in mCRPC. These treatments share a common goal of inhibiting pathways critical to cancer progression, similar to the investigational drug Opevesostat.

What other types of research exist?

Promising novel alternatives to Opevesostat for prostate cancer patients in 2024 include: 1) Sipuleucel-T, an immunotherapy that has shown improved overall survival in mCRPC patients. 2) Pembrolizumab, a PD-1 inhibitor for patients with specific genetic markers (dMMR or high TMB). 3) Ra-223, a radiopharmaceutical for patients with bone metastases, which has shown improved survival and reduced skeletal-related events. 4) BAT (Bipolar Androgen Therapy), which has shown potential in restoring sensitivity to other hormonal therapies like enzalutamide and abiraterone.

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Hormone Therapy

Opevesostat + Hormone Therapy for Prostate Cancer

Phase 3

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

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

Must have

Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization

Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 82 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new drug called opevesostat for advanced prostate cancer patients who don't respond to usual care. The drug aims to stop the cancer from growing and spreading, potentially helping patients live longer.

Who is the study for?

This trial is for men with advanced prostate cancer that has spread and worsened despite hormone therapy. They must have tried one hormonal drug already, be in good physical shape (able to perform daily activities), and have normal organ function. Men who've had small cell prostate cancer or more than six cycles of a specific chemotherapy aren't eligible.

What is being tested?

The study compares MK-5684 plus hormone replacement against other drugs like abiraterone acetate or enzalutamide in controlling advanced prostate cancer. It measures how long patients live without their disease getting worse on scans and overall survival, especially focusing on those with certain genetic features of the cancer.

What are the potential side effects?

Possible side effects include fatigue, nausea, skin rash, changes in blood pressure due to hormone treatments, liver function changes from MK-5684, and potential allergic reactions to any of the medications used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My prostate cancer is confirmed and not of the small cell type.

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My scans show cancer has spread to my bones or other parts of my body.

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I have either been treated with PARPi, was considered not suitable for it, or I refused PARPi treatment.

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My testosterone levels are below 50 ng/dL due to ongoing treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 82 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 82 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 82 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Radiographic Progression-free Survival (rPFS)

Secondary study objectives

Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Total Score

Duration of Response (DOR)

Number of Participants Who Discontinue Study Treatment Due to an AE

+9 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: hormone replacement therapy (HRT)+ opevesostatExperimental Treatment4 Interventions

Participants receive opevesostat 5 mg by oral tablets twice daily (BID) plus dexamethasone 1.5 mg by oral tablets and fludrocortisone acetate 0.1 mg oral tablet once daily (QD) continuously until disease progression. Hydrocortisone 100 mg (oral or intramuscular \[IM\]) will also be provided to participants for use as rescue medication.

Group II: Alternative next generation hormonal agent (NHA)Active Control3 Interventions

Participants receive Abiraterone 1000 mg QD by oral tablets plus Prednisone 5 mg BID by oral tablets or Enzalutamide 160 mg QD by oral tablets until disease progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Hydrocortisone

2005

Completed Phase 4

~1280

Fludrocortisone acetate

2024

Completed Phase 1

~20

0 / 5Eligibility criteria met

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, such as abiraterone acetate and enzalutamide, work by targeting the androgen receptor pathway, which is essential for the growth and survival of prostate cancer cells. Abiraterone acetate inhibits the enzyme CYP17A1, reducing androgen production, while enzalutamide blocks androgen receptors, preventing androgens from stimulating cancer cell growth. Understanding these mechanisms is crucial for patients as it helps in selecting the most effective treatment based on the cancer's specific characteristics and progression, potentially improving outcomes and managing resistance to therapy.

Recent Advances in Epigenetic Biomarkers and Epigenetic Targeting in Prostate Cancer.