Pluvicto for the Treatment of African American Men With Metastatic Castration-Resistant Prostate Cancer

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07860554
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Metastatic Castration-Resistant Prostate Adenocarcinoma
  • Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Lutetium Lu 177 Vipivotide Tetraxetan — DRUG
    Given IV
  • PSMA PET Scan — PROCEDURE
    Undergo PSMA PET scan
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Single Photon Emission Computed Tomography — PROCEDURE
    Undergo SPECT

Study Details

This phase II trial tests how well Pluvicto works in treating African American patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that has continued to grow and spread despite the surgical removal of the testes or medical intervention to block androgen production (castration-resistant). Pluvicto is a targeted radioligand therapy. It works like a guided missile, combining tumor seeking molecules with a radioactive isotope. It circulates through the bloodstream, binds to a protein on prostate cancer cells called prostate specific membrane antigen, and destroys them using radiation. Pluvicto is approved by the Food and Drug Administration for the treatment of metastatic castration-resistant prostate cancer. This trial may help researchers determine the safety and efficacy of Pluvicto specifically in African American patients with metastatic castration-resistant prostate cancer.

Key Dates

First listed
Oct 6, 2026
Start date
Nov 2, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
88 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Pluvicto)
    Patients receive Pluvicto IV on day 1 of each cycle. Cycles repeat every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo PSMA PET scan, CT scan, bone scan, collection of blood samples, and optional SPECT scans and pre- and post-treatment biopsies.

Primary Outcome Measure

Radiographic progression-free survival (rPFS) [ Time Frame: From the start of study treatment to the first objective documentation of radiographic disease progression or death, assessed up to 36 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Jacob E. Berchuck, MD
[email protected]
404-778-1900
Jacob E. Berchuck, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Emory University Hospital/Winship Cancer Institute· Atlanta, GA

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