Trial Outcomes & Findings for Pertuzumab, Trastuzumab, Hyaluronidase-zzxf and Enzalutamide for Treatment of Metastatic Castration-Resistant Prostate Cancer (NCT NCT05730712)
NCT ID: NCT05730712
Last Updated: 2026-05-15
Results Overview
ORR is defined as the proportion 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.
COMPLETED
PHASE2
7 participants
Up to 1 year
2026-05-15
Participant Flow
Participant milestones
| Measure |
Treatment (HP, Enzalutamide)
Patients 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.\> \> Biopsy: Undergo biopsy\>
\> Biospecimen Collection: Undergo collection of blood and tissue samples\>
\> Computed Tomography: Undergo CT\>
\> Echocardiography: Undergo ECHO\>
\> Enzalutamide: Given PO\>
\> Hyaluronidase-zzxf/Pertuzumab/Trastuzumab: Given SC\>
\> Magnetic Resonance Imaging: Undergo MRI\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pertuzumab, Trastuzumab, Hyaluronidase-zzxf and Enzalutamide for Treatment of Metastatic Castration-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Treatment (HP, Enzalutamide)
n=7 Participants
Patients 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.\> \> Biopsy: Undergo biopsy\>
\> Biospecimen Collection: Undergo collection of blood and tissue samples\>
\> Computed Tomography: Undergo CT\>
\> Echocardiography: Undergo ECHO\>
\> Enzalutamide: Given PO\>
\> Hyaluronidase-zzxf/Pertuzumab/Trastuzumab: Given SC\>
\> Magnetic Resonance Imaging: Undergo MRI\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|
|
Age, Continuous
|
66.0 years
n=11 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=11 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=11 Participants
|
|
ECOG Performance Status
0
|
6 Participants
n=11 Participants
|
|
ECOG Performance Status
1
|
1 Participants
n=11 Participants
|
|
PSA
|
11.2 ng/mL
n=11 Participants
|
|
Gleason Total Score
7
|
2 Participants
n=11 Participants
|
|
Gleason Total Score
9
|
3 Participants
n=11 Participants
|
|
Gleason Total Score
10
|
2 Participants
n=11 Participants
|
|
Any Prior Radiotherapy
|
5 Participants
n=11 Participants
|
|
Any Metastatic Disease
|
7 Participants
n=11 Participants
|
|
Lymph Node Metastatic Site
|
5 Participants
n=11 Participants
|
|
Liver Metastatic Site
|
1 Participants
n=11 Participants
|
|
Subcutaneous Tissue Metastatic Site
|
0 Participants
n=11 Participants
|
|
Abdominal Wall Metastatic Site
|
0 Participants
n=11 Participants
|
|
Bone Metastatic Site
|
5 Participants
n=11 Participants
|
|
CNS Metastatic Site
|
0 Participants
n=11 Participants
|
|
Lung Metastatic Site
|
4 Participants
n=11 Participants
|
|
Other Metastatic Site
|
4 Participants
n=11 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearORR is defined as the proportion 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.
Outcome measures
| Measure |
Treatment (HP, Enzalutamide)
n=6 Participants
Patients 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.
\>
\> Biopsy: Undergo biopsy
\>
\> Biospecimen Collection: Undergo collection of blood and tissue samples
\>
\> Computed Tomography: Undergo CT
\>
\> Echocardiography: Undergo ECHO
\>
\> Enzalutamide: Given PO
\>
\> Hyaluronidase-zzxf/Pertuzumab/Trastuzumab: Given SC
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|
|
Overall Response Rate (ORR)
|
50 percentage of participants
Interval 11.81 to 88.19
|
SECONDARY outcome
Timeframe: Up to 1 yearPFS 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.
Outcome measures
| Measure |
Treatment (HP, Enzalutamide)
n=6 Participants
Patients 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.
\>
\> Biopsy: Undergo biopsy
\>
\> Biospecimen Collection: Undergo collection of blood and tissue samples
\>
\> Computed Tomography: Undergo CT
\>
\> Echocardiography: Undergo ECHO
\>
\> Enzalutamide: Given PO
\>
\> Hyaluronidase-zzxf/Pertuzumab/Trastuzumab: Given SC
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|
|
Progression-free Survival (PFS)
|
NA months
Interval 2.52 to
There are not enough events to calculate median and upper bound.
|
SECONDARY outcome
Timeframe: Up to 1 yearOS is defined as the time from study entry to death from any cause.
Outcome measures
| Measure |
Treatment (HP, Enzalutamide)
n=6 Participants
Patients 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.
\>
\> Biopsy: Undergo biopsy
\>
\> Biospecimen Collection: Undergo collection of blood and tissue samples
\>
\> Computed Tomography: Undergo CT
\>
\> Echocardiography: Undergo ECHO
\>
\> Enzalutamide: Given PO
\>
\> Hyaluronidase-zzxf/Pertuzumab/Trastuzumab: Given SC
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|
|
Overall Survival (OS)
|
NA months
Interval 3.75 to
There are not enough events to calculate median and upper bounds.
|
SECONDARY outcome
Timeframe: Up to 1 yearThe 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.
Outcome measures
| Measure |
Treatment (HP, Enzalutamide)
n=7 Participants
Patients 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.
\>
\> Biopsy: Undergo biopsy
\>
\> Biospecimen Collection: Undergo collection of blood and tissue samples
\>
\> Computed Tomography: Undergo CT
\>
\> Echocardiography: Undergo ECHO
\>
\> Enzalutamide: Given PO
\>
\> Hyaluronidase-zzxf/Pertuzumab/Trastuzumab: Given SC
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|
|
Number of Participants With Treatment-related Grade 3 or Higher Adverse Event
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearAssessed 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. .
Outcome measures
| Measure |
Treatment (HP, Enzalutamide)
n=7 Participants
Patients 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.
\>
\> Biopsy: Undergo biopsy
\>
\> Biospecimen Collection: Undergo collection of blood and tissue samples
\>
\> Computed Tomography: Undergo CT
\>
\> Echocardiography: Undergo ECHO
\>
\> Enzalutamide: Given PO
\>
\> Hyaluronidase-zzxf/Pertuzumab/Trastuzumab: Given SC
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|
|
Change in Quality of Life (QoL) From Baseline
|
-2.00 score on a scale
Interval -11.5 to 0.39
|
Adverse Events
Treatment (HP, Enzalutamide)
Serious adverse events
| Measure |
Treatment (HP, Enzalutamide)
n=7 participants at risk
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
14.3%
1/7 • Number of events 2 • Up to 1 year
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
Other adverse events
| Measure |
Treatment (HP, Enzalutamide)
n=7 participants at risk
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
2/7 • Number of events 2 • Up to 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • Number of events 2 • Up to 1 year
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
|
General disorders and administration site conditions
Fatigue
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
|
Investigations
Neutrophil count decreased
|
14.3%
1/7 • Number of events 3 • Up to 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
42.9%
3/7 • Number of events 7 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
28.6%
2/7 • Number of events 5 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.6%
2/7 • Number of events 2 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
1/7 • Number of events 2 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Ataxia
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Dysgeusia
|
42.9%
3/7 • Number of events 3 • Up to 1 year
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Paresthesia
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 2 • Up to 1 year
|
|
Vascular disorders
Hypertension
|
42.9%
3/7 • Number of events 15 • Up to 1 year
|
|
Vascular disorders
Thromboembolic event
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place