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Castration-Resistant Prostate CarcinomaPhase 2NCT05730712

Pertuzumab, Trastuzumab, Hyaluronidase-zzxf and Enzalutamide for Treatment of Metastatic Castration-Resistant Prostate Cancer

A Phase 2 study testing Biopsy, Biospecimen Collection and Computed Tomography in people with Castration-Resistant Prostate Carcinoma and Stage IVB Prostate Cancer AJCC v8, run by Mayo Clinic at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This phase II trial tests how well pertuzumab, trastuzumab, hyaluronidase-zzxf and enzalutamide works in treating patients with castration-resistant prostate cancer that has spread from where it first started to other places in the body (metastatic). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Biopsy, Biospecimen Collection and Computed Tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
3 sitesUnited States
Study dates
8 Mar 2024to 10 Apr 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • PRE-REGISTRATION: Age >= 18 years.
  • PRE-REGISTRATION: Clinically or histologically confirmed diagnosis of second-generation antiandrogen-refractory metastatic castration-resistant prostate cancer.
  • PRE-REGISTRATION: Measurable disease as defined by the Prostate Cancer Working Group (PCWG3) criteria.
  • PRE-REGISTRATION: Prior treatment required:
  • Second generation anti-androgen (2GAA) therapy (e.g., enzalutamide, abiraterone) at any time prior registration.
  • PRE-REGISTRATION: Provide written informed consent.
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  • PRE-REGISTRATION: Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
  • PRE-REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance.
  • PRE-REGISTRATION: Willingness to provide mandatory blood specimens for correlative research.
  • PRE-REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research.
  • REGISTRATION: Plasma NRG-1 level >= 4 ng/ml
  • REGISTRATION: Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.
  • REGISTRATION: Hemoglobin >= 9.0 g/dL
  • REGISTRATION: Absolute neutrophil count (ANC) >= 1500/mm^3
  • REGISTRATION: Platelet count >= 100,000/mm^3
  • REGISTRATION: Total bilirubin =< 1.5 x upper limit of normal (ULN)
  • REGISTRATION: Alanine aminotransferase (ALT) and aspartate transaminase (AST) =< 3 x ULN (=< 5 x ULN for patients with liver involvement).
  • REGISTRATION: PT/INR/aPTT =<1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy.
  • REGISTRATION: Calculated creatinine clearance >= 45 ml/min using the Cockcroft-Gault formula.
  • REGISTRATION: Left ventricular ejection fraction (LVEF) >= 50% =< 15 days prior to registration.
  • REGISTRATION: Provide written informed consent.
  • REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance.
  • REGISTRATION: Willingness to provide mandatory blood specimens for correlative research.
  • REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research.
  • REGISTRATION: Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).

Who cannot join

  • PRE-REGISTRATION: History of myocardial infarction =< 6 months prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life threatening ventricular arrhythmias.
  • PRE-REGISTRATION: Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment.
  • EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment.
  • PRE-REGISTRATION: Uncontrolled intercurrent non-cardiac illness including, but not limited to:
  • Ongoing or active infection
  • Psychiatric illness/social situations
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  • Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
  • Any other conditions that would limit compliance with study requirements
  • PRE-REGISTRATION: Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.
  • NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
  • PRE-REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the prostate cancer.
  • PRE-REGISTRATION: Thromboembolic event =< 60 days prior to pre-registration.
  • PRE-REGISTRATION: Serious cardiac illness or medical conditions including, but not confined to, the following:
  • History of NCI CTCAE v5.0 Grade >= 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) Class >= II
  • High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate >= 100/min at rest, significant ventricular arrhythmia [ventricular tachycardia], or higher-grade atrioventricular [AV]-block, such as second-degree AVblock Type 2 [Mobitz II] or third-degree AV-block)
  • Serious cardiac arrhythmia or severe conduction abnormality not controlled by adequate medication
  • Angina pectoris requiring anti-angina medication
  • Clinically significant valvular heart disease
  • Evidence of transmural infarction on electrocardiogram (ECG)
  • Poorly controlled hypertension (e.g., systolic > 180 mm Hg or diastolic > 100mmHg)
  • PRE-REGISTRATION: Serious cardiac arrhythmia or severe conduction abnormality not controlled by adequate medication.
  • PRE-REGISTRATION: Angina pectoris requiring anti-angina medication.
  • PRE-REGISTRATION: Clinically significant valvular heart disease.
  • PRE-REGISTRATION: Evidence of transmural infarction on electrocardiogram (ECG).
  • PRE-REGISTRATION: Poorly controlled hypertension (e.g., systolic > 180 mm Hg or diastolic > 100mmHg).
  • PRE-REGISTRATION: History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease (e.g., severe left ventricular systolic dysfunction [LVSD], left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome.
  • REGISTRATION: Any of the following because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects:
  • Pregnant persons
  • Nursing persons
  • Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception
  • REGISTRATION: Failure to recover from any of the following therapies prior to registration:
  • Major surgery
  • Chemotherapy
  • Infection requiring systemic treatment
  • REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • REGISTRATION: Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy.
  • NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
  • REGISTRATION: Uncontrolled intercurrent illness including, but not limited to:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Or psychiatric illness/social situations that would limit compliance with study requirements.
  • REGISTRATION: Currently receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  • REGISTRATION: Other active malignancy =< 3 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment (e.g., other hormonal therapy, chemotherapy) for their cancer.
  • REGISTRATION: History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
  • REGISTRATION: Known hypersensitivity to pertuzumab, or trastuzumab, or hyaluronidase, or to any of its excipients.
  • REGISTRATION: Requirement for drugs or substances which can interfere with the actions of the study drugs (enzalutamide or pertuzumab/trastuzumab/hyaluronidase-zzxf). Consult pharmacist for review.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: Phase II Trial of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf (HP) Plus Enzalutamide for the Treatment of Selected Patients With Metastatic Castration-Resistant Prostate Cancer (TraPPer)

This phase II trial tests how well pertuzumab, trastuzumab, hyaluronidase-zzxf and enzalutamide works in treating patients with castration-resistant prostate cancer that has spread from where it first started to other places in the body (metastatic). Pertuzumab and trastuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called human epidermal growth factor receptor-2 (HER2). HER2 is found on some cancer cells. When pertuzumab or trastuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows pertuzumab and trastuzumab to be given by injection under the skin and shortens their administration time compared to pertuzumab or trastuzumab alone. Chemotherapy drugs, such as enzalutamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pertuzumab, trastuzumab, hyaluronidase-zzxf and enzalutamide may kill more cancer cells.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Evaluate the preliminary efficacy of the combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf plus enzalutamide with regard to objective response rate (Prostate Cancer Clinical Trials Working Group 3 [PCWG 3.0]) in enzalutamide-refractory metastatic castration-resistant prostate cancer.

SECONDARY OBJECTIVES:

  1. Estimate the radiographic progression-free survival for this combination. II. Estimate the overall survival for this combination.

EXPLORATORY OBJECTIVES:

  1. Assessment of this combination for adverse events according to clinical judgment and patient-reported outcomes (Patient Reported Outcomes-Common Terminology Criteria for Adverse Events [PRO-CTCAE] - Prostate Cancer).

II. Assessment of patient quality of life using Functional Assessment of Cancer Therapy- Prostate (FACT-P) questionnaire.

CORRELATIVE OBJECTIVES:

  1. Determine the correlation between outcomes as above and systemic NRG-1 levels at baseline and over time.

II. Determine the correlation between outcomes as above and change in HER2/HER3/androgen receptor (AR) gene signatures.

OUTLINE:

Patients receive pertuzumab, trastuzumab, and hyaluronidase-zzxf subcutaneously (SC) on day 1 of each cycle and enzalutamide orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography (ECHO), biopsy, computed tomography (CT), and magnetic resonance imaging (MRI) scans and collection of blood samples throughout the study.

After completion of study treatment, patients are followed up every 3 months until progressive disease then every 6 months thereafter.

Being tested
Biopsy, Biospecimen Collection, Computed Tomography, Echocardiography, Enzalutamide
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood and tissue samples

  • Computed TomographyProcedure or surgery

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

    Undergo CT

  • EchocardiographyProcedure or surgery

    Also called EC

    Undergo ECHO

  • EnzalutamideDrug

    Also called ASP9785, MDV3100, Xtandi

    Given PO

  • Hyaluronidase-zzxf/Pertuzumab/TrastuzumabDrug

    Also called Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf, Pertuzumab/Trastuzumab/Hyaluronidase-zzxf, Phesgo

    Given SC

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR

    Undergo MRI

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT05730712
Study groupRoleWhat they receive
Treatment (HP, enzalutamide)ExperimentalPatients receive pertuzumab, trastuzumab, and hyaluronidase-zzxf SC on day 1 of each cycle and enzalutamide PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO, biopsy, CT, and MRI scans and collection of blood samples throughout the study.
Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography; Drug: Enzalutamide; Drug: Hyaluronidase-zzxf/Pertuzumab/Trastuzumab; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration

What is being measured

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

  1. Overall Response Rate (ORR)

    ORR is defined as the percentage of patients who experience either a partial response or complete response as defined by Prostate Cancer Working Group 3 (PCWG3). Overall Response per Prostate Cancer Working Group 3 (PCWG3) is a composite assessment integrating soft-tissue disease evaluated by RECIST v1.1 and bone disease evaluated separately using PCWG3 bone scan criteria. Complete Response (CR) is disappearance of all soft-tissue target lesions (with lymph nodes <10 mm short axis) and no bone progression; Partial Response (PR) is a ≥30% decrease in the sum of diameters of soft-tissue target lesions with no bone progression; Stable Disease (SD) is neither CR/PR nor Progressive Disease. Progressive Disease (PD) is declared by radiographic progression in either domain, defined as RECIST v1.1 progression or confirmed bone progression using the PCWG3 2+2 rule for new bone lesions, regardless of PSA changes.

    Measured: Up to 1 year

Secondary outcomes (4)

  1. Progression-free Survival (PFS)

    PFS is defined as the time from study entry to the first of either confirmed radiographic disease progression or death from any cause, determined based on Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria.

    Measured: Up to 1 year

  2. Overall Survival (OS)

    OS is defined as the time from study entry to death from any cause.

    Measured: Up to 1 year

  3. Number of Participants With Treatment-related Grade 3 or Higher Adverse Event

    The rate of patients experiencing any Grade 3 or higher adverse event > deemed at least possibly related to treatment will be reported. The maximum grade for each type of adverse event by patient will also be

    > summarized by frequencies and percentages using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: Up to 1 year

  4. Change in Quality of Life (QoL) From Baseline

    Assessed using the Functional Assessment of Cancer Therapy - Prostate (FACT-P), a 39-item questionnaire that measures quality of life (QOL) in men with prostate cancer. Questions are answered on a scale of 0-4 where 0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; and 4=very much. FACT-P is composed of five subscales: Physical Well-Being (7 items; score range 0-28), Social/Family Well-Being (7 items; 0-28), Emotional Well-Being (6 items; 0-24), Functional Well-Being (7 items; 0-28), and the Prostate Cancer Subscale (12 items; 0-48). Subscale scores are summed to compute a total FACT-P score ranging from 0 to 156, with higher scores indicating better quality of life and lower scores indicating worse quality of life. Patient responses to the FACT-P will be summarized descriptively by the change in FACT-P score from baseline at last assessment. .

    Measured: Up to 1 year

Timeline

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

  1. First posted16 Feb 2023
  2. Study start8 Mar 2024
  3. Primary completion10 Apr 2025
  4. Study completion10 Apr 2025

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
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05730712
Sponsor's protocol ID
MC210504
Other IDs
NCI-2022-10773, MC210504, 21-013057
Status last verified
May 2026
First submitted
7 Feb 2023
Last updated
9 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biopsy, Biospecimen Collection and Computed Tomography in people with Castration-Resistant Prostate Carcinoma and Stage IVB Prostate Cancer AJCC v8, run by Mayo Clinic at 3 sites 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 25 inclusion and 48 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: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Yes. Results are posted in the registry (first posted 15 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Up to 1 year). 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 NCT05730712.

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 9 Jun 2026.

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