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Metastatic Castration-Resistant Prostate AdenocarcinomaPhase 2PluvEquityNCT07860554

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

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Bone Scan in people with Metastatic Castration-Resistant Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, run by Emory University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Biopsy Procedure, Biospecimen Collection and Bone Scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteUnited States
Study dates
2 Nov 2026to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Participants must self-identify as being African-American
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
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  • Participants must have histological pathological, and/or cytological confirmation of adenocarcinoma of the prostate
  • Participants have PSMA-positive disease on PSMA scan
  • Participants must have a castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L)
  • Participants must have progressed only once on prior second generation androgen receptor-directed therapy (ARDT) (abiraterone, enzalutamide, darolutamide, or apalutamide)
  • First generation androgen receptor inhibitor therapy (e.g. bicalutamide) is allowed but not considered as prior ARDT therapy
  • Second generation ARDT must be the most recent therapy received
  • Participants must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:
  • Serum/plasma PSA progression defined as 2 increases in PSA measured at least 1 week apart. The minimal start value is 2.0 ng/mL; 1.0 ng/mL is the minimal starting value if confirmed rise in PSA is the only indication of progression
  • Soft-tissue progression defined (Prostate Cancer Working Group Scher Prostate Cancer 2016 Oncology Response Criteria [PCWG3]-modified Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1 [Eisenhauer et al 2009, Scher et al 2016])
  • Progression of bone disease: two new lesions; only positivity on the bone scan defines metastatic disease to bone (PCWG3 criteria [Scher et al 2016])
  • Participants must have ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to randomization
  • Participants must have recovered to ≤ grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, etc.) except alopecia
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
  • Platelets ≥ 100 x 10^9/L
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin < 2 x the institutional upper limit of normal (ULN). For participants with known Gilbert's syndrome ≤ 3 x ULN is permitted
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 x ULN OR ≤ 5.0 x ULN for participants with liver metastases
  • Estimate glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73m^2 using the Modification of Diet in Renal Disease (MDRD) equation
  • Albumin ≥ 2.5 g/dL
  • Candidates for change in ARDT as assessed by the treating physician
  • Participants cannot have previously progressed nor had intolerable toxicity to both enzalutamide and abiraterone

Who cannot join

  • 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
  • Known hypersensitivity to any of the study treatments or its excipients or to drugs of similar classes
  • Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, biological therapy, or investigational therapy
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  • Transfusion or use of bone marrow stimulating agents for the sole purpose of making a subject eligible for study inclusion
  • Participants with a history of central nervous system (CNS) metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity. Participants with CNS metastases are eligible if received therapy (surgery, radiotherapy, gamma knife), asymptomatic and neurologically stable without corticosteroids. Participants with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired
  • A superscan as seen in the baseline bone scan, defined as 99mTc bone scintigraphy pattern demonstrating diffuse, confluent, and intense radiotracer uptake throughout the majority of the axial and appendicular skeleton, with markedly reduced or absent renal visualization and minimal soft tissue activity
  • Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression
  • History or current diagnosis of the following electrocardiography (ECG) abnormalities indicating significant risk of safety for study participants:
  • Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third degree AV block)
  • History of familial long QT syndrome or known family history of Torsades de Pointe
  • Cardiac or cardiac repolarization abnormality, including any of the following: history of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to starting study treatment
  • Concurrent serious (as determined by the principal investigator) medical conditions, including, but not limited to New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation
  • HIV-infected participants who are at a low risk of AIDS-related outcomes may participate in this trial
  • Participants with an active documented coronavirus disease 2019 (COVID-19) infection (any grade of disease severity) at time of informed consent may be included only when completely recovered (in accordance with local guidance)
  • Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. Participants with a prior history of malignancy that has been adequately treated and who have been disease free and treatment free for more than 3 years prior to randomization are eligible, as are participants with adequately treated non-melanoma skin cancer and superficial bladder cancer
  • Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 14 weeks after stopping study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF
  • Unmanageable concurrent bladder outflow obstruction or urinary incontinence. Note: Participants with bladder outflow obstruction or urinary incontinence, which is manageable and controlled with best available standard of care (including [incl.] pads, drainage) are allowed
  • History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
  • Any condition that precludes raised arms position
  • Eligible for treatments other than ARDT based on presence of any mutations or biomarkers that are known as predictors of better response (e.g., AR-V7 or BRCA)
  • Not able to understand and to comply with study instructions and requirements

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wilena Session contact

404-778-3448

wsessio@emory.edu

United States1 site

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Jacob E. Berchuck, MD, 404-778-1900, jberchuck@emory.edu

    Jacob E. Berchuck, MD

Other trials in United States

About this study

Official title: A Phase II Study to Validate the Efficacy and Safety of Pluvicto in African American Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To establish the clinical efficacy of lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in African American (AA) men with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on one androgen receptor pathway inhibitor (ARPI) and have not been treated with taxane chemotherapy for mCRPC.

SECONDARY OBJECTIVES:

  1. To establish in AA men with mCRPC who have progressed on one androgen receptor (AR) pathway inhibitor and have not been treated with taxane chemotherapy for mCRPC the:

Ia. Safety and tolerability of Pluvicto; Ib. Overall survival following treatment with Pluvicto; Ic. Objective radiographic response rate to Pluvicto; Id. Prostate specific antigen (PSA) response rate to Pluvicto; Ie. Impact of Pluvicto on quality of life.

TERTIARY/EXPLORATORY OBJECTIVES:

  1. Identify tumor genomic and transcriptional profiles that are associated with response to Pluvicto in AA men.

II. Identify circulating tumor deoxyribonucleic acid (DNA) molecular features that are associated with response to Pluvicto in AA men.

III. Evaluate the association of genetic ancestry with response to Pluvicto in AA men.

OUTLINE:

Patients receive Pluvicto intravenously (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 prostate specific membrane antigen (PSMA) positron emission tomography (PET), computed tomography (CT), bone scan, single photon emission computed tomography (SPECT), collection of blood samples, and optional biopsy throughout the trial.

After completion of study treatment, patients are followed up every 3 months for up to 36 months.

Being tested
Biopsy Procedure, Biospecimen Collection, Bone Scan, Computed Tomography, Lutetium Lu 177 Vipivotide Tetraxetan
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo collection of blood samples

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Lutetium Lu 177 Vipivotide TetraxetanDrug

    Also called 177Lu-labeled PSMA-617, 177Lu-PSMA-617, AAA 617, AAA-617

    Given IV

  • PSMA PET ScanProcedure or surgery

    Also called Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography

    Undergo PSMA PET scan

  • Questionnaire AdministrationOther

    Ancillary studies

  • Single Photon Emission Computed TomographyProcedure or surgery

    Also called Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography

    Undergo SPECT

Study groups in NCT07860554
Study groupRoleWhat they receive
Treatment (Pluvicto)ExperimentalPatients 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.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Drug: Lutetium Lu 177 Vipivotide Tetraxetan; Procedure: PSMA PET Scan; Other: Questionnaire Administration; Procedure: Single Photon Emission Computed Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Up to 36 months

  5. Prostate specific antigen (PSA) response rate

    Will be defined as the proportion of subjects achieving a ≥ 50% decline (PSA50) or ≥ 90% decline (PSA90) in PSA from baseline, confirmed per Prostate Cancer Working Group Scher Prostate Cancer 2016 Oncology Response criteria. PSA50 and PSA90 will be summarized with 2-sided 95% confidence intervals using the Clopper-Pearson method.

    Measured: Up to 36 months

  6. Health related quality of life (FACT-P)

    Will be quantified through patient-reported outcome instruments administered during study participation using the Functional Assessment of Cancer Therapy-Prostate (FACT-P). Descriptive statistics such as mean, median, interquartile range, and min/max will be reported for continuous variables, and frequencies and percentages will be reported for categorical variables.

    Measured: Up to 36 months

  7. Health related quality of life (FACT-RNT)

    Will be quantified through patient-reported outcome instruments administered during study participation using the Functional Assessment of Cancer Therapy-Radionuclide Therapy (FACT-RNT). Descriptive statistics such as mean, median, interquartile range, and min/max will be reported for continuous variables, and frequencies and percentages will be reported for categorical variables.

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2026
  2. Study start2 Nov 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07860554
Sponsor's protocol ID
2026P000169
Other IDs
P30CA138292, NCI-2026-06345, WINSHIP6884-26, 2026P000169
Acronym
PluvEquity
Status last verified
Sep 2026
First submitted
25 Sep 2026
Last updated
6 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Bone Scan in people with Metastatic Castration-Resistant Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wilena Session (404-778-3448, wsessio@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07860554.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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