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Prostate Cancer MetastaticPhase 2CaRPETNCT06610825

Castrate Resistant Prostate Cancer Enhertu Therapy

A Phase 2 study testing Enhertu in people with Prostate Cancer Metastatic and Prostate Cancer, run by Washington D.C. Veterans Affairs Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Use of Enhertu as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer Metastatic, Prostate Cancer, CRPC
What is being tested?
Enhertu
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
5 Mar 2025to Oct 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • ECOG 0 or 1
  • LVEF at least 50%
  • Adequate Blood Clotting function
  • Adequate Organ and Bone Marrow function
  • Adequate Renal function
  • Adequate Hepatic function

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Asha Escobar contact

2027431090

asha.escobar@va.gov

Martha Antonio contact

martha.antonio@va.gov

United States1 site, 1 recruiting

  • Washington DC VAMC

    Washington D.C., District of Columbia, 20422

    Asha Escobar, 2027431090, asha.escobar@Va.gov

    Maneesh Jain, MD

    Recruiting

Other trials in United States

About this study

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

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

Read the 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.

Being tested
Enhertu
Keywords
prostate cancer, metastatic prostate cancer, Enhertu, HER2 positive, Trastuzumab deruxtecan, crpc, phase 2
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnhertuDrug

    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.

Study groups in NCT06610825
Study groupRoleWhat they receive
Enhertu for HER2 positive metastatic castrate resistant prostate cancerExperimentalNot described
Receives: Drug: Enhertu

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

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

    Measured: 2 years

Secondary outcomes (4)

  1. Progression Free Survival

    Measured: 2 years

  2. Overall Survival

    Measured: 2 years

  3. Disease Control Rate

    Measured: 2 years

  4. Duration of Response

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2024
  2. Study start5 Mar 2025
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06610825
Sponsor's protocol ID
1803020
Acronym
CaRPET
Status last verified
Apr 2026
First submitted
20 Sep 2024
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zamalloa N, Rose J, Lap CJ, Rajendran R, Estephan F, Jatwani K, Poudel A, Subrahmanyam R, Hurley PJ, Nava VE, Jain M. Historical Perspective of HER2 Testing and Treatment in Prostate Cancer. Curr Oncol. 2026 Feb 2;33(2):91. doi: 10.3390/curroncol33020091.

    PubMed 41744855

  • 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.

    PubMed 40638235

  • 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.

    PubMed 39496182

  • 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.

    PubMed 38622987

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enhertu in people with Prostate Cancer Metastatic and Prostate Cancer, run by Washington D.C. Veterans Affairs Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Asha Escobar (2027431090, asha.escobar@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06610825, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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