Enhertu for Prostate Cancer

(CaRPET Trial)

Overseen By Asha Escobar

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Washington D.C. Veterans Affairs Medical Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Maneesh Jain, MD

Principal Investigator

Washington DC VA Medical Center

Kerry Schaffer, MD

Principal Investigator

Vanderbilt University

Eric Knoche, MD

Principal Investigator

VA St. Louis Healthcare System

Julie Graff, MD

Principal Investigator

Portland VA Medical Center

Linda Verkruyse, MD

Principal Investigator

VA Kansas City

Bruce Montgomery, MD

Principal Investigator

VA Puget Sound HCS

David Kosoff, MD

Principal Investigator

Wisconsin VA Medical Center

Fayez Estephan, MD

Principal Investigator

George Washington University Cancer Center

Eligibility Criteria

Men with advanced prostate cancer that has spread and is resistant to hormone therapy can join. They must have tried other treatments like hormone blockers or chemotherapy, keep taking drugs to lower testosterone, and have a confirmed diagnosis of adenocarcinoma. A tissue sample for testing if the cancer reacts to HER2 treatment is also needed.

Inclusion Criteria

My cancer has worsened despite hormone therapy and possibly chemotherapy.

My tumor sample is prepared for HER2 testing.

My prostate cancer is confirmed to be adenocarcinoma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Enhertu as a subsequent line of therapy for HER2-positive metastatic castration-resistant prostate adenocarcinoma

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Enhertu

Trial Overview The trial tests Enhertu in men whose prostate cancer has worsened despite previous treatments. It's specifically for those with HER2-positive tumors, which means their cancer cells have more of a certain protein that the drug targets.

Participant Groups

Group I: Enhertu for HER2 positive metastatic castrate resistant prostate cancer Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Washington D.C. Veterans Affairs Medical Center

Lead Sponsor

Trials

45

Recruited

18,500+

Daiichi Sankyo

Industry Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Cancer Research And Biostatistics

Collaborator

Trials

1

Recruited

60+

Institute for Clinical Research

Collaborator

Trials

5

Recruited

980+