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

Conditions

• Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Enoblituzumab — DRUG
  Enoblituzumab 15mg/kg IV (in the vein) every 2 weeks for 12 weeks prior to radical prostatectomy on day 84.
• Standard of Care — OTHER
  Radical prostatectomy within 4-8 weeks of randomization.

Study Details

This study evaluates the efficacy, anti-tumor effect, and immunogenicity of neoadjuvant enoblituzumab given before radical prostatectomy. Patients will be randomized to enoblituzumab for a total of 12 weeks beginning 84 days before radical prostatectomy or standard of care arms.

Key Dates

Start date

Feb 16, 2024

Status verified

Oct 2025

Primary completion

Mar 1, 2029

Completion

Mar 1, 2029

Study Design

Enrollment

219 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Enoblituzumab
  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.
• Active Comparator: Standard of Care
  Patients will undergo standard of care radical prostatectomy within 4-8 weeks of randomization.

Primary Outcome Measure

Recurrence-free survival (RFS) [ Time Frame: 3 years post-prostatectomy ]

Central Contacts

• Carolyn Chapman GU oncology
  4109551239
  [email protected]
• Carolyn Chapman, RN
  443-287-7841

Locations (5)

Find similar trials in Chicago, IL

Related Studies

• Collection of Blood From Patients With Cancer
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
  Enrolling By Invitation · National Institutes of Health Clinical Center (CC) · Bethesda, Maryland
• Follow-Up Study of Subjects Previously Enrolled in Poxviral Vector Gene Transfer Studies
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Collection of Blood From Patients With Prostate Cancer
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland