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

ConditionsMetastatic Castration-Resistant Prostate AdenocarcinomaStage IVB Prostate Cancer AJCC v8
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorEmory University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have the ability to understand and sign an approved informed consent form (ICF) prior to participation in any study procedures

Participants must have the ability to understand and comply with all protocol requirements

Participants must have the ability to understand and comply with institutional radiation safety requirements

Participants must be ≥ 18 years of age

Disqualifiers

Previous treatment with any of the following within 6 months of enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation

Previous PSMA-targeted radioligand therapy is not allowed

Prior treatment with cytotoxic chemotherapy for castration resistant or castrate sensitive prostate cancer (e.g., taxanes, platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy or biological therapy (including monoclonal antibodies). (Note: Taxane exposure [maximum 6 cycles] in the adjuvant or neoadjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neoadjuvant therapy. Prior treatment with sipuleucel-T is allowed)

Any investigational agents within 28 days prior to day of randomization

Trial design

Design model

Single group

Treatments tested in this trial

  • Biopsy Procedure

    Procedure/Surgery

    Undergo biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood samples

  • Bone Scan

    Procedure/Surgery

    Undergo bone scan

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Lutetium Lu 177 Vipivotide Tetraxetan

    Drug

    Given IV

  • PSMA PET Scan

    Procedure/Surgery

    Undergo PSMA PET scan

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Single Photon Emission Computed Tomography

    Procedure/Surgery

    Undergo SPECT

Treatment groups

88 Participants
are divided into 1 treatment group
Group A: Treatment (Pluvicto)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Radiographic progression-free survival (rPFS)

Will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median rPFS will be estimated using the Brookmeyer-Crowley approach.

Time frame
From the start of study treatment to the first objective documentation of radiographic disease progression or death, assessed up to 36 months

Secondary outcomes

1

Incidence of adverse events

Will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Frequencies and percentages will be used to summarize safety events. Toxicities will be tabulated by grade, association, and cycle number.

Time frame
Up to 36 months
2

Overall survival

Will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median overall survival will be estimated using the Brookmeyer-Crowley approach.

Time frame
From the start of study treatment to the date of death, assessed up to 36 months
3

Objective response rate

ORR is defined as the proportion of subjects achieving a best overall response of complete response (CR) or partial response (PR). Will be summarized with a 2-sided 95% confidence interval using the Clopper-Pearson method.

Time frame
Up to 36 months
4

Disease control rate (DCR)

DCR is defined as the proportion of subjects achieving a best overall response of CR, PR, or stable disease.

Time frame
Up to 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Novartis

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: