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Trial Title:
Castrate Resistant Prostate Cancer Enhertu Therapy
NCT ID:
NCT06610825
Condition:
Prostate Cancer Metastatic
Prostate Cancer
CRPC
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
prostate cancer
metastatic prostate cancer
Enhertu
HER2 positive
Trastuzumab deruxtecan
crpc
phase 2
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Enhertu
Description:
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.
Arm group label:
Enhertu for HER2 positive metastatic castrate resistant prostate cancer
Summary:
Use of Enhertu as a Subsequent Line of Therapy in HER2-Positive Metastatic
Castration-Resistant Prostate Adenocarcinoma.
Detailed description:
This Phase II clinical trial aims to evaluate the efficacy and safety of Enhertu in HER-2
positive mCRPC who have progressed on prior androgen deprivation therapy and novel
hormonal agents, who are either not candidates for or have refused taxane based
chemotherapy. Led by Dr. Maneesh Jain at the Washington DC VA, the open label multi
center study will include 60 participants treated with Enhertu. Primary endpoints focus
on objective response rates, while secondary measures include safety, progression-free
survival, overall survival, and quality of life.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Pathologically confirmed adenocarcinoma of the prostate
- 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
Exclusion Criteria:
- History of interstitial lung disease or pneumonitis requiring steroids
- Significant coronary vascular disease
- Previous exposure to HER2 targeted therapy
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 2024
Completion date:
October 2028
Lead sponsor:
Agency:
Washington D.C. Veterans Affairs Medical Center
Agency class:
U.S. Fed
Collaborator:
Agency:
Daiichi Sankyo
Agency class:
Industry
Collaborator:
Agency:
Cancer Research And Biostatistics
Agency class:
Other
Collaborator:
Agency:
Institute for Clinical Research
Agency class:
Other
Source:
Washington D.C. Veterans Affairs Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06610825
https://www.enhertu.com/
