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NCT05730712 · ClinicalTrials.gov registry record · Phase 2
Pertuzumab, Trastuzumab, Hyaluronidase-zzxf and Enzalutamide for Treatment of Metastatic Castration-Resistant Prostate Cancer
A Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
- 3
- Study locations
NCT05730712: Completed Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, sponsored by Mayo Clinic.
NCT05730712 is a Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma that has completed, run by Mayo Clinic. The registered enrollment target is 7 participants, below the 177-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05730712, a Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
- 3
- Study locations
Study 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). 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.
Primary Outcome
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
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- DRUG Enzalutamide
- PROCEDURE Echocardiography
Study Locations (3)
Arizona
- Mayo Clinic in Arizona - Scottsdale
Florida
- Mayo Clinic in Florida - Jacksonville
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2024-03-08 |
| Est. Completion | 2025-04-10 |
| Phase | Phase 2 |
What the finished NCT05730712 record still lists
NCT05730712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 177-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Stage IVB Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05730712 reports a single indexed study location in Arizona, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05730712 about?
NCT05730712 is a clinical study titled "Pertuzumab, Trastuzumab, Hyaluronidase-zzxf and Enzalutamide for Treatment of Metastatic Castration-Resistant Prostate Cancer". 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 antibod...
What is the current status of trial NCT05730712?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2024-03-08. Estimated completion is 2025-04-10.
What conditions does trial NCT05730712 study?
This clinical trial studies the following conditions: Stage IVB Prostate Cancer AJCC v8, Castration-Resistant Prostate Carcinoma.
What interventions are being tested in trial NCT05730712?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Enzalutamide (DRUG), Echocardiography (PROCEDURE).
Who is sponsoring clinical trial NCT05730712?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05730712 being conducted?
This trial has 3 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05730712's enrollment target sits among peer trials
7 44th of 45 higher than 1 of 45 other Stage IVB Prostate Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IVB Prostate Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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