Castrate Resistant Prostate Cancer Enhertu Therapy

NCT06610825 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 1803020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Use of Enhertu as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma.

Conditions

Prostate Cancer Metastatic; Prostate Cancer; CRPC

Keywords

prostate cancer; metastatic prostate cancer; Enhertu; HER2 positive; Trastuzumab deruxtecan; crpc; phase 2

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate by local review, combining radiographic and biochemical responses

  2 years

Secondary Outcomes (4)

• Progression Free Survival

  2 years

• Overall Survival

  2 years

• Disease Control Rate

  2 years

• Duration of Response

  2 years

Study Arms (1)

Enhertu for HER2 positive metastatic castrate resistant prostate cancer

EXPERIMENTAL

Drug: Enhertu

Interventions

Enhertu DRUG

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.

Enhertu for HER2 positive metastatic castrate resistant prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Washington D.C. Veterans Affairs Medical Center: lead
• Daiichi Sankyo: collaborator
• Cancer Research And Biostatistics: collaborator
• Institute for Clinical Research: collaborator

Study Sites (1)

Washington DC VAMC

Washington D.C., District of Columbia, 20422, United States

RECRUITING

Related Publications (4)

• Zamalloa, N.; Rose, J.; Lap, C.J.; Rajendran, R.; Estephan, F.; Jatwani, K.; Poudel, A.; Subrahmanyam, R.; Hurley, P.J.; Nava, V.E.; et al. Historical Perspective of HER2 Testing and Treatment in Prostate Cancer. Curr. Oncol. 2026, 33, 91. https://doi.org/10.3390/curroncol33020091

  BACKGROUND

• 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.

  PMID: 40638235 RESULT

• 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.

  PMID: 39496182 RESULT

• 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.

  PMID: 38622987 RESULT

Related Links

• Enhertu Drug Information

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Maneesh Jain, MD

  Washington DC VA Medical Center

  STUDY CHAIR

• Eric Knoche, MD

  VA St. Louis Healthcare System

  PRINCIPAL INVESTIGATOR

• Suman Kambhampati, MD

  VA Kansas City

  PRINCIPAL INVESTIGATOR

• Julie Graff, MD

  Portland VA Medical Center

  PRINCIPAL INVESTIGATOR

• Bruce Montgomery, MD

  VA Puget Sound HCS

  PRINCIPAL INVESTIGATOR

• David Kosoff, MD

  Wisconsin VA Medical Center

  PRINCIPAL INVESTIGATOR

• Kerry Schaffer, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asha Escobar

CONTACT

2027431090; asha.escobar@va.gov

Martha Antonio

CONTACT

martha.antonio@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: March 5, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)