Clinical trial NCT06610825: Castrate Resistant Prostate Cancer Enhertu Therapy
Official title: A Phase II Clinical Trial to Evaluate the Efficacy and Safety of Fam-Trastuzumab Deruxtecan-Nxki (T-DXd) as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer Metastatic
Prostate Cancer
CRPC
Keywords: prostate cancer
metastatic prostate cancer
Enhertu
HER2 positive
Trastuzumab deruxtecan
crpc
phase 2
Lead sponsor: Washington D.C. Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Daiichi Sankyo
name: Cancer Research And Biostatistics
name: Institute for Clinical Research
First posted: 2024-09-24
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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
* 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:

* History of interstitial lung disease or pneumonitis requiring steroids
* Significant coronary vascular disease
* Previous exposure to HER2 targeted therapy

Primary outcomes:
measure: ORR
timeFrame: 2 years
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
measure: Disease Control Rate
timeFrame: 2 years
measure: Duration of Response
timeFrame: 2 years
Other outcomes:
Locations:
city: Washington DC
country: United States
facility: Washington DC VAMC
state: District of Columbia
Study officials:
affiliation: Washington DC VA Medical Center
name: Maneesh Jain, MD
role: STUDY_CHAIR
affiliation: VA St. Louis Healthcare System
name: Eric Knoche, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Kansas City
name: Linda Verkruyse, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Portland VA Medical Center
name: Julie Graff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Puget Sound HCS
name: Bruce Montgomery, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wisconsin VA Medical Center
name: David Kosoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: George Washington University Cancer Center
name: Karan Jatwani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Kerry Schaffer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.