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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

Must not have

Other histologic types of prostate cancers such as ductal, sarcomatous, lymphoma, small cell, and neuroendocrine tumors

Presence of known lymph node involvement on CT (N1 by PSMA allowed with up to 3 LNs each ≤1 cm) or distant metastases by CT and NM bone scan

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years post-prostatectomy

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

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

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My prostate cancer is not the usual type.

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My scans show cancer has spread to my lymph nodes or other parts.

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I have received immunotherapy or vaccine therapy for prostate cancer.

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I am not taking any hormonal therapy or medications for prostate enlargement.

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I have an autoimmune disease that needs treatment with drugs that affect my immune system.

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I do not have any severe infections or heart, lung, blood, or mental health conditions that would make me unsuitable for the study.

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I have received treatments like radiation, hormone therapy, or chemotherapy for prostate cancer.

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

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

Primary study objectives

Recurrence-free survival (RFS)

Secondary study objectives

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 study objectives

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%

Weight loss

100%

Hypocalcemia

100%

Hypoalbuminemia

100%

Hyperglycemia

100%

Anorexia

100%

Abdominal pain

100%

Pain

100%

Chills

100%

Alanine aminotransferase increased

100%

Alkaline phosphatase increased

100%

Bloating

100%

Lymphocyte count decreased

100%

Neoplasms benign, malignant and

100%

Anemia

100%

Vomiting

100%

Flatulence

100%

Fatigue

100%

Fever

100%

Platelet count decreased

100%

White blood cell decreased

100%

Aspartate aminotransferase increased

100%

Proteinuria

100%

Dyspnea

100%

Pruritus

100%

Constipation

100%

Nausea

100%

Hyponatremia

100%

Myalgia

100%

Headache

100%

Insomnia

100%

Hematoma

100%

Hypotension

100%

80%

60%

40%

20%

Study treatment Arm

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

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

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

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

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 / 11Eligibility criteria met