Enhertu for Prostate Cancer

(CaRPET Trial)

Recruiting at 1 trial location

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?

This trial explores whether Enhertu, a HER2-targeted therapy, can treat metastatic castration-resistant prostate cancer, which is difficult to manage. The researchers aim to determine if Enhertu is effective for patients whose cancer has progressed despite other hormone treatments. Men with this type of prostate cancer who have not previously received HER2-targeted therapy may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, ongoing androgen deprivation therapy (ADT) is required to keep testosterone levels low.

Is there any evidence suggesting that Enhertu is likely to be safe for humans?

Previous studies have shown that Enhertu generally has a favorable safety profile. Most side effects were mild to moderate, meaning they were not severe and could be managed. The FDA has already approved Enhertu for breast cancer, indicating its recognized safety to some extent.

While researchers are studying Enhertu for prostate cancer, its use in other cancers provides some understanding of its effects. Serious side effects were less common, but they did occur. Prospective participants should always discuss potential risks and benefits with the study team before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Enhertu is unique because it targets HER2-positive metastatic castrate-resistant prostate cancer, a specific subset of prostate cancer that is particularly aggressive and challenging to treat. Unlike standard treatments like hormone therapy or chemotherapy, Enhertu is an antibody-drug conjugate that directly delivers a potent chemotherapy agent to the cancer cells, which may improve targeting and reduce side effects. Researchers are excited about Enhertu because it offers a novel mechanism of action that could potentially provide more effective treatment options for patients with this difficult-to-treat cancer type.

What evidence suggests that Enhertu might be an effective treatment for prostate cancer?

Studies have shown that Enhertu, also known as fam-trastuzumab deruxtecan-nxki, effectively treats HER2-positive cancers. Previous research found that Enhertu reduced the risk of cancer progression or death by 44% in patients with HER2-positive metastatic breast cancer. Although this study focused on breast cancer, the results are promising for similar cancers, such as HER2-positive metastatic castration-resistant prostate cancer. In this trial, participants will receive Enhertu to evaluate its effectiveness in treating HER2-positive metastatic castration-resistant prostate cancer. Enhertu delivers a cancer-fighting drug directly to cancer cells, helping to stop their growth. Early findings in prostate cancer patients have shown positive responses, suggesting that Enhertu could be a beneficial treatment for this specific type of prostate cancer. ^{1 2 4 6 7}

Who Is on the Research Team?

Eric Knoche, MD

Principal Investigator

VA St. Louis Healthcare System

Kerry Schaffer, MD

Principal Investigator

Vanderbilt University

Julie Graff, MD

Principal Investigator

Portland VA Medical Center

Bruce Montgomery, MD

Principal Investigator

VA Puget Sound HCS

Maneesh Jain, MD

Principal Investigator

Washington DC VA Medical Center

Suman Kambhampati, MD

Principal Investigator

VA Kansas City

David Kosoff, MD

Principal Investigator

Wisconsin VA Medical Center

Karan Jatwani, MD

Principal Investigator

George Washington University Cancer 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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06610825

Castrate Resistant Prostate Cancer Enhertu Therapy 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12401083/

Clinical response to novel combination of trastuzumab ... Clinical response to novel combination of trastuzumab deruxtecan and abiraterone in HER2-expressing metastatic castration-resistant prostate cancer · Abstract.

3. careacross.com careacross.com/clinical-trials/trial/NCT06610825

Castrate Resistant Prostate Cancer Enhertu Therapy Primary endpoints focus on objective response rates, while secondary measures include safety, progression-free survival, overall survival, and quality of life.

4. enhertuhcp.com enhertuhcp.com/en/breast/efficacy/efficacy-data

Efficacy data | ENHERTU® (fam-trastuzumab deruxtecan-nxki) Median time to first onset was 5.5 months (range: 0.9 to 31.5). Fatal outcomes due to ILD and/or pneumonitis occurred in 0.9% of patients treated with ENHERTU.

5. astrazeneca-us.com astrazeneca-us.com/media/press-releases/2025/ENHERTU-fam-trastuzumab-deruxtecan-nxki-plus-pertuzumab-reduced-the-risk-of-disease-progression-or-death-by-44-percent-vs-THP-as-1st-line-therapy-in-patients-with-HER2-positive-metastatic-breast-cancer-in-DESTINY-Breast09-Phase-III-trial.html

ENHERTU® (fam-trastuzumab deruxtecan-nxki) plus ... ENHERTU® (fam-trastuzumab deruxtecan-nxki) plus pertuzumab reduced the risk of disease progression or death by 44% vs. THP as 1st-line therapy ...

6. enhertuhcp.com enhertuhcp.com/en/breast/safety

Safety Data | ENHERTU® (fam-trastuzumab deruxtecan-nxki) The benefit-risk profile of ENHERTU was established in DESTINY-Breast031. The majority of adverse reactions were Grade 1 or 21,2.

7. aacrjournals.org aacrjournals.org/clincancerres/article/31/12_Supplement/LB1-04/752273/Abstract-LB1-04-Efficacy-and-safety-of-trastuzumab

Efficacy and safety of trastuzumab deruxtecan (T-DXd) vs ... Efficacy and safety of trastuzumab deruxtecan (T-DXd) vs physician's choice of chemotherapy (TPC) by pace of disease progression on prior ...