Enhertu for Prostate Cancer

(CaRPET Trial)

Overseen By Martha Antonio

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Washington D.C. Veterans Affairs Medical Center

Must be taking: Androgen deprivation therapy

Must not be taking: HER2 targeted therapy

Disqualifiers: Interstitial lung disease, Coronary vascular disease, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Karan Jatwani, MD

Principal Investigator

George Washington University Cancer Center

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+