Health TrialsbyHealthPanel

Castrate Resistant Prostate Cancer Enhertu Therapy

ConditionsProstate Cancer MetastaticProstate CancerCRPC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorWashington D.C. Veterans Affairs Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

History of interstitial lung disease or pneumonitis requiring steroids

Significant coronary vascular disease

Previous exposure to HER2 targeted therapy

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Enhertu for HER2 positive metastatic castrate resistant prostate cancerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

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

Time frame
2 years

Secondary outcomes

1

Progression Free Survival

Time frame
2 years
2

Overall Survival

Time frame
2 years
3

Disease Control Rate

Time frame
2 years
4

Duration of Response

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington D.C. Veterans Affairs Medical Center

Lead sponsor

Daiichi Sankyo

Collaborator

Cancer Research And Biostatistics

Collaborator

Institute for Clinical Research

Collaborator

Source ClinicalTrials.gov
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