Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-03-05
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Enhertu for HER2 positive metastatic castrate resistant prostate cancer
Enhertu
This is an open label, multi-center, single arm, phase II study designed to investigate the anti-tumor activity, efficacy and safety of Enhertu in HER2-positive metastatic castrate-resistant prostate cancer patients who progressed on androgen deprivation therapy and novel hormonal agents (such as Abiraterone and Enzalutamide), who also progressed, refused, or were not candidates to receive taxane-based chemotherapy.
Interventions
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Enhertu
This is an open label, multi-center, single arm, phase II study designed to investigate the anti-tumor activity, efficacy and safety of Enhertu in HER2-positive metastatic castrate-resistant prostate cancer patients who progressed on androgen deprivation therapy and novel hormonal agents (such as Abiraterone and Enzalutamide), who also progressed, refused, or were not candidates to receive taxane-based chemotherapy.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of mCRPC
* Documented progression on androgen deprivation and novel hormonal agents, with or without progression on taxane containing regimen
* Ongoing ADT to maintain serum testosterone levels below 50 ng/dL
* Formalin fixed paraffin embedded tumor tissue for HER2 immunohistochemistry
* Life expectancy 6 months
* ECOG 0 or 1
* LVEF at least 50%
* Adequate Blood Clotting function
* Adequate Organ and Bone Marrow function
* Adequate Renal function
* Adequate Hepatic function
Exclusion Criteria
* Significant coronary vascular disease
* Previous exposure to HER2 targeted therapy
18 Years
MALE
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Cancer Research And Biostatistics
UNKNOWN
Institute for Clinical Research
OTHER
Washington D.C. Veterans Affairs Medical Center
FED
Responsible Party
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Principal Investigators
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Maneesh Jain, MD
Role: STUDY_CHAIR
Washington DC VA Medical Center
Eric Knoche, MD
Role: PRINCIPAL_INVESTIGATOR
VA St. Louis Healthcare System
Suman Kambhampati, MD
Role: PRINCIPAL_INVESTIGATOR
VA Kansas City
Julie Graff, MD
Role: PRINCIPAL_INVESTIGATOR
Portland VA Medical Center
Bruce Montgomery, MD
Role: PRINCIPAL_INVESTIGATOR
VA Puget Sound HCS
David Kosoff, MD
Role: PRINCIPAL_INVESTIGATOR
Wisconsin VA Medical Center
Karan Jatwani, MD
Role: PRINCIPAL_INVESTIGATOR
George Washington University Cancer Center
Kerry Schaffer, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Locations
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Washington DC VAMC
Washington D.C., District of Columbia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Rajendran R, Lap CJ, Madapoosi S, Heiraty A, Estephan F, Hahn W, Poudel A, Nava VE, Subrahmanyam R, Jain M. Clinical response to novel combination of trastuzumab deruxtecan and abiraterone in HER2-expressing metastatic castration-resistant prostate cancer. Oncologist. 2025 Sep 1;30(9):oyaf207. doi: 10.1093/oncolo/oyaf207.
Lap CJ, Rajendran R, Martin JM, Uppal M, Escobar A, Heiraty AM, Estephan F, Hahn W, Subrahmanyam R, Nava VE, Jain M. Response of Human Epidermal Growth Factor Receptor 2-Expressing Prostate Cancer to Trastuzumab Deruxtecan. Ann Intern Med. 2024 Dec;177(12):1738-1741. doi: 10.7326/ANNALS-24-01409. Epub 2024 Nov 5. No abstract available.
Estephan F, Lap CJ, Banagan J, Antonio M, Liu S, Diao G, Rozalen AZ, Rajendran R, Krasnow S, Subrahmanyam R, Nava VE, Jain M. The prevalence and clinical significance of HER2 expression in prostate adenocarcinoma. Ann Diagn Pathol. 2023 Dec;67:152219. doi: 10.1016/j.anndiagpath.2023.152219. Epub 2023 Oct 20.
Related Links
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Enhertu Drug Information
Other Identifiers
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1803020
Identifier Type: -
Identifier Source: org_study_id
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