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Neoadjuvant Enoblituzumab for Prostate Cancer (HEAT Trial)

Phase 2

Recruiting

Led By Eugene Shenderov

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

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

Must have

Radical prostatectomy has been scheduled

Age ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years post-prostatectomy

Awards & highlights

HEAT Trial Summary

This trial evaluates a therapy (enoblituzumab) given before surgery to treat prostate cancer. Patients will be randomly assigned to receive the therapy or standard care.

Who is the study for?

Men with high-risk localized prostate cancer that hasn't spread to lymph nodes, bones, or organs. Eligible participants must have a specific type of tumor (adenocarcinoma), certain levels of blood cells and organ function, agree to use barrier contraception, and be able to follow study requirements. Those who've had prior treatments for prostate cancer or have other health conditions like autoimmune diseases are excluded.Check my eligibility

What is being tested?

The trial is testing the effectiveness of Enoblituzumab given before surgery compared to standard care in men with high-risk prostate cancer. Participants will either receive Enoblituzumab for 12 weeks before their scheduled radical prostatectomy or undergo the usual treatment without this drug.See study design

What are the potential side effects?

Enoblituzumab may cause immune-related reactions because it's designed to activate the body's defense system against cancer cells. This can sometimes lead to inflammation in various parts of the body, which might result in symptoms like fatigue, skin rashes, fever, or more serious issues depending on where the reaction occurs.

HEAT Trial Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for a surgery to remove my prostate.

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I am 18 years old or older.

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I am fully active or able to carry out light work.

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My initial prostate biopsy shows significant cancer presence.

HEAT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years post-prostatectomy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years post-prostatectomy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years post-prostatectomy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recurrence-free survival (RFS)

Secondary outcome measures

Anti-tumor response (central pathological response graded according to standard criteria) to enoblituzumab versus SOC

Anti-tumor response (cleaved PARP staining and quantification of tumor cell apoptosis) to enoblituzumab versus SOC

Assess the immune response (CD8 Granzyme B) to enoblituzumab versus SOC

+9 more

Other outcome measures

Cytokines and chemokines

FC Receptor Genotyping

Global Expression Profiling of Tumor Tissues

+12 more

Side effects data

From 2022 Phase 1 trial • 3 Patients • NCT04630769

100%

Investigations - Other, specify

100%

Abdominal pain

100%

Infections and infestations - Other,

100%

Nausea

100%

Skin infection

100%

Blood and lymphatic system disorders - Other, specify

100%

Lymphocyte count decreased

100%

White blood cell decreased

100%

Thromboembolic event

100%

Anemia

100%

Blood lactate dehydrogenase increased

100%

Abdominal distension

100%

Small intestinal obstruction

100%

Anorexia

100%

Diarrhea

100%

Vomiting

100%

Sore throat

100%

Dyspepsia

100%

Constipation

100%

General disorders and administration site conditions - Other, specify

100%

Hepatobiliary disorders - Other, specify

100%

Hypocalcemia

100%

Neutrophil count decreased

100%

Hypoalbuminemia

100%

Renal and urinary disorders - Other, specify

100%

Proteinuria

100%

Edema limbs

100%

Fatigue

100%

Urinary tract infection

100%

Hypomagnesemia

100%

Hyponatremia

100%

Back pain

100%

80%

60%

40%

20%

Study treatment Arm

Monotherapy: IP FT516 at 9 x 10^7 Cells/Dose on Day 1, 8, and 15

Monotherapy: IP FT516 at 9 x 10^8 Cells/Dose on Day 1, 8, and 15

Monotherapy: IP FT516 at 3 x 10^8 Cells/Dose on Day 1, 8, and 15

HEAT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EnoblituzumabExperimental Treatment1 Intervention

Men with localized intermediate and high-risk prostate cancer will be given neoadjuvant Enoblituzumab 15mg/kg IV every 2 weeks for 12 weeks, followed by a radical prostatectomy on day 84, with follow-up visits 30 days, 90 days, 6 months, and 9 months post-prostatectomy. PSA values will be tracked for 3 years post-prostatectomy.

Group II: Standard of CareActive Control1 Intervention

Patients will undergo standard of care radical prostatectomy within 4-8 weeks of randomization.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enoblituzumab

2021

Completed Phase 1

~180

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

558 Previous Clinical Trials

32,701 Total Patients Enrolled

56 Trials studying Prostate Cancer

3,129 Patients Enrolled for Prostate Cancer

MacroGenicsIndustry Sponsor

48 Previous Clinical Trials

5,157 Total Patients Enrolled

3 Trials studying Prostate Cancer

279 Patients Enrolled for Prostate Cancer

Eugene ShenderovPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Enoblituzumab been granted clearance by the Federal Drug Administration?

"Taking into account the Phase 2 status of Enoblituzumab, Power assessed its safety as a 2 on their scale. This is due to limited evidence for efficacy while some data points exist which attest to safety."

Answered by AI

Are there any remaining vacancies for this research study?

"According to the current information on clinicaltrials.gov, this particular medical study is no longer enrolling individuals as it was last updated in August of 2023. Nevertheless, there are still 1356 alternative trials actively seeking participants for their respective research projects."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Neoadjuvant Enoblituzumab vs SOC in Men With High-Risk Localized Prostate Cancer

2024. "Trial of Neoadjuvant Enoblituzumab vs SOC in Men With High-Risk Localized Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06014255.