What side effects are associated with this type of intervention?

Common treatments for prostate cancer, including androgen deprivation therapy (ADT), abiraterone, enzalutamide, and chemotherapy agents like docetaxel and cabazitaxel, have distinct side effect profiles. ADT can cause hot flashes, decreased libido, and osteoporosis. Abiraterone is associated with hypertension and hypokalemia. Enzalutamide may lead to fatigue, hot flashes, and a risk of seizures. Chemotherapy agents like docetaxel and cabazitaxel can cause neuropathy, alopecia, and myelosuppression. Proton beam therapy (PBT) primarily results in gastrointestinal and genitourinary adverse effects. Each treatment's side effects should be carefully considered in consultation with a healthcare provider.

What prior FDA approvals exist?

Several drugs have received FDA approval for the treatment of advanced prostate cancer. Androgen receptor inhibitors such as enzalutamide, apalutamide, and darolutamide block the androgen receptor signaling pathway, which is crucial for prostate cancer cell growth. Radioligand therapies like lutetium Lu 177 vipivotide tetraxetan target prostate-specific membrane antigen (PSMA) to deliver radiation directly to cancer cells. Immunotherapies, including sipuleucel-T, stimulate the immune system to attack prostate cancer cells. These treatments have shown efficacy in improving overall survival and progression-free survival in various clinical trials.

What other types of research exist?

Promising novel alternatives to JNJ-80038114 for prostate cancer patients include: 1) Relugolix, an oral gonadotropin-releasing hormone antagonist, which offers a new approach for advanced prostate cancer. 2) JNJ-63576253, a next-generation androgen receptor antagonist effective against wild-type and clinically relevant ligand binding domain mutations in metastatic castration-resistant prostate cancer. 3) BAT (Bipolar Androgen Therapy), which has shown potential in restoring sensitivity to abiraterone and enzalutamide in patients with metastatic castration-resistant prostate cancer.

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JNJ-80038114 for Prostate Cancer

Phase 1

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

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

Must have

At least 1 prior treatment for mCRPC

Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3)

Must not have

Brain metastasis or known seizure history

Known allergies to JNJ-80038114 or its excipients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find the best amount of a new drug, JNJ-80038114, and ensure it is safe for people who might benefit from it.

Who is the study for?

Men with advanced prostate cancer who have already tried at least one treatment can join this trial. They should be in good physical shape (able to perform daily activities without much help) and have their major organs working well. Participants must agree to use effective birth control, and they cannot have brain metastases, a history of seizures, severe ongoing side effects from previous cancer treatments, or allergies to the study drug.

What is being tested?

The trial is testing JNJ-80038114's safety and optimal dosing for men with advanced prostate cancer. The first part will find the best dose by gradually increasing it among different groups. In the second part, more people will take this found dose to see how safe it is.

What are the potential side effects?

Possible side effects are not detailed here but may include reactions related to prior anticancer therapies since participants with severe lasting effects from such treatments are excluded.

Eligibility Criteria

Inclusion Criteria

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

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I have had at least one treatment for metastatic castration-resistant prostate cancer.

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My prostate cancer has spread and does not respond to hormone therapy.

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

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My organ functions are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain metastasis or a history of seizures.

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I am allergic to JNJ-80038114 or its ingredients.

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I am not currently receiving any cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years 6 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

Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)

Parts 1 and 2: Number of Participants With AEs by Severity

Parts 1 and 2: Number of Participants With Adverse Events (AEs)

Secondary study objectives

Duration of Response (DOR)

Number of Participants With Antibodies to JNJ-80038114

Objective Response Rate (ORR)

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: Dose ExpansionExperimental Treatment1 Intervention

Participants will receive JNJ-80038114 at the recommended Phase 2 dose (RP2D) determined in Part 1.

Group II: Part 1: Dose EscalationExperimental Treatment1 Intervention

Participants will receive JNJ-80038114. The dose levels will be escalated based on the dose limiting toxicities (DLTs) evaluation by the study evaluation team (SET).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

JNJ-80038114

2022

Completed Phase 1

~40

0 / 7Eligibility 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

Prostate cancer treatments primarily target the androgen receptor pathway, which is crucial for prostate cancer cell growth. Androgen deprivation therapy (ADT) reduces testosterone levels, slowing cancer progression. Chemotherapy, such as docetaxel, disrupts cancer cell division. Newer targeted therapies, like enzalutamide and abiraterone, inhibit androgen receptor signaling more precisely. Understanding these mechanisms helps patients and doctors choose the most effective treatment, manage side effects, and improve outcomes.

Focal therapy for localized prostate cancer in the era of routine multi-parametric MRI.Androgen deprivation therapy in advanced prostate cancer: is intermittent therapy the new standard of care?Overview of international collaborative group prostate cancer trials.